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Website denta.ro SLOVMEDICA September 24th -26th 2009 SLOVMEDICA presents an opportunity for experts active in the field of medicine working in hospitals nursing homes as well as expert health education and science to meet with representatives of companies providing products and services in a wide range of healthcare fields. The exhibition is to present the latest medical techniques technologies and equipment. SLOVMEDICA is the most important event of its kind in Slovakia and will be taking place alongside two other prominent health care exhibitions NON HANDICAP and SLOVAK DENTAL DAYS. Website http // incheba.sk/exhibitions/1717 NON HANDICAP September 24th -26th 2009 7th International exhibition of exhibitors promoting equipment and medical aids for the disabled. Website http // incheba.sk/exhibitions/1717 Global Healthcare Technologies Team SLOVAK DENTAL DAYS September 24th -26th 2009 Website http // incheba.sk/exhibitions/Exhibition_SDD_2009/1738 10th annual specialized Exhibition of Stomatological Instruments Tools and Materials under the banner of the SLOVAK DENTAL DAYS. The exhibition is supported by the Slovak Chamber of Dentists and Association of Dental Producers and Sellers. Throughout its existence the Slovak Dental Days exhibition have established a significant position in the calendar of dental exhibitions in Slovakia and given its size side events and number of exhibitors it remains a very attractive event in its category. Available Market Research Dental Equipment and Services 2009 U.S. Commercial Service Contact Information Name Lucia Maskova Position Commercial Specialist Email lucia.maskova #x40 N0SPAM. trade.gov Phone 00421 2 5920 5317 Global Healthcare Technologies Team Spain Capital Madrid Population 45 million GDP* $1.5 trillion Currency Euro Language Spanish official Catalan-Valenciano Galician and Basque Summary The total healthcare equipment market is estimated at over USD 4 billion. Health spending in Spain is 8.2% of GDP compared with an average of 9% in OECD countries 15% in the U.S 11.1% in France and 10.7% in Germany. U.S. medical equipment is highly regarded by Spanish medical professionals and domestic importers/distributors. The healthcare sector depends heavily on imports which represent approximately 85 percent of the total market. The United States is the one of the main suppliers to Spain with approximately 35 percent of total imports estimated at $1.2 billion. Spain has a public comprehensive medical system. The public sector accounts for approximately 8590 percent of the sector’s activity while the private sector accounts for the remainder. Given the current economic situation greater emphasis is being placed on cost-effective products and equipment to help reduce healthcare costs. Market Entry / Barriers All medical products/equipment imported into Spain need to have the CE Mark. The exporter also needs to notify the Ministry of Health. Importers of medical products require an authorization issued by the Ministry of Health. As a consequence of the requirement that medical products need the CE Mark many U.S. companies have been centralizing their import operations into one single country from which they register and distribute their products to the rest of the EU. The official approach to vitamins and health supplements in Spain is quite different to that of the United States. Certain vitamins and supplements commonly found in the U.S. health food stores are still considered by the Spanish Ministry of Health as prescription medicine and may need to be approved as such. U.S. companies interested in the Spanish market need to provide the Spanish Ministry of Health with technical data on the product’s composition and need to meet the labeling requirements. The approval of products considered drugs can be lengthy. The import of refurbished medical equipment into Spain is technically permitted but both public and private medical providers in Spain have traditionally preferred new equipment. U.S. products that are competitive in price or innovative in the U.S. market have a better chance of success in Spain. There is zero duty on medical devices. Global Healthcare Technologies Team Current Market Trends While the Spanish medical equipment sector has grown over the last several years current budgetary concerns and the growing demand on public health resources is limiting growth somewhat. Nonetheless once the financial situation improves demand should pick up as spending catches up on that of other developed countries. Patients are also becoming more demanding. There is room for more modern and sophisticated equipment. Furthermore life expectancy continues to improve. A growing ageing population will generate greater demand for products directly connected with geriatric ailments and illnesses. Main Competitors The United States and Germany are the two main suppliers with France the U.K. Italy and Switzerland following. However France the U.K. and Holland are also used as storage and redistribution centers for U.S. companies. Imports from Asia are on the rise. Many suppliers in the Spanish industry are subsidiaries of overseas corporations including leading U.S. firms. These well-established firms often represent serious competition for companies trying to break into the market. U.S. medical equipment is highly regarded by Spanish doctors domestic importers and distributors. However there has been a significant shift in sourcing in the disposables segment. More and more disposables are being imported from Asia. The explanation given by sector contacts is that the Public Health System as the principal end-user of imports is leaning more and more towards cheaper disposable products in an effort to restrain expenditures. Current Demand Both the public and private sectors provide healthcare in Spain. The public system accounts for 85 - 90 percent of total healthcare expenditure. The private sector covers the rest. The volume and pricing of healthcare /pharmaceutical products is influenced by official healthcare policies. Because of the current economic situation demand for products has decreased and cost-efficiency has become a determining factor in many cases. The problem of late payments has also been aggravated. Global Healthcare Technologies Team Trade Events ORPROTEC November 26-28 2009 Valencia International Fair for Orthopedics and Assisted Living. Technology for the Disabled and the Senior Citizens. http //orprotec.feriavalencia / EXPODENTAL March 11 – 13 2010 Madrid Dental Equipment Supplies and Services Show. http // ifema.es/web/ferias/expodental/default_i.html U.S. Commercial Service Contact Information Name Helen Crowley Position Commercial Specialist Email helen.crowley #x40 N0SPAM. trade.gov Phone +34 91 308 1548 Global Healthcare Technologies Team Sweden Capital Stockholm Population 9.3 million GDP* $358.4 billion 2008 estimate Currency Swedish Krona Language Swedish Summary The Swedish population of just over 9 million enjoys a very good health. Sweden invests about 9 per cent of its GDP in health and medical services. The infant mortality rate is less than 3.4 deaths per 1 000 in the first year of life and the average life expectancy is 78 years for men and 82 years for women. There are about 30 500 doctors in Sweden or one for every 320 inhabitants. Outpatient care is organized into primary care districts each with 5 000 to 50 000 inhabitants. In 2007 the medical device market employing some 10 000 people was estimated at $3.7 billion and imports of medical devices were estimated at $2 billion. The dental equipment market employing some 7 600 dentists of whom 3 300 work in the private sector was estimated at USD 227 million. U.S. suppliers of dental equipment hold a market share of some 12 percent. Market Entry Sweden’s customs laws and regulations follow those of the EU. This means that Sweden applies external EU tariffs to imports from the U.S. and other non-EU countries. Goods imported to Sweden are also subject to a value-added-tax VAT of 25%. Marking and labeling requirement must follow EU standards and all instruction manuals must be translated into Swedish. Sweden uses the metric system. Products sold in Sweden should be adapted for use with the metric system whenever possible. Electric current in Sweden is 50 Hz AC 230V single-phase and 230/240V three-phase. In Sweden three political and administrative bodies control health care for the country the central government the county councils and the municipalities. The 21 county councils have the responsibility to provide health and medical services and to work for a good standard of health among the population. The county councils decide on the allocation of the resources to the health services and are responsible for the overall planning of the services offered. It is also the county councils that own and run the hospitals health centers and other institutions. The 290 municipalities are responsible for the nursing homes care of the elderly and the disabled. Private health care accounting for some ten percent of total health care costs mainly offers primary care like running health care centers or homes for the elderly. There are a few hospitals that are managed by private entrepreneurs. U.S. firms interested in entering the Swedish market will find that the market is highly competitive and are therefore recommended to establish a local presence either through local agents and distributors or sales subsidiaries. Global Healthcare Technologies Team Current Market Trends The two main factors that are expected to have strong effects on the future Swedish health care system are -an aging population which is likely to lead to increased demand for health care products as well as health care related services such as equipment and supplies for the home health care sector. -Life style related diseases diabetes overweight etc . Main Competitors U.S. suppliers dominate the import market and enjoy a good reputation. Major third-country competitors include Germany Netherlands and Denmark. Domestic production is strong and the medical device sector is one of the leading export sectors in Sweden. Some of the internationally known Swedish medtech companies include Gambro dialysis equipment blood component products Getinge Medical Systems Extended Car and Infection Control Molnlycke Healthcare single- use surgical and wound care and Elekta the Leksell Gamma Knife Major Swedish dental equipment manufacturers include AstraTech implants Nobel Biocare dental implants and TePe oral health products . Main export markets are the Netherlands Norway and Finland. Current Demand Although the health care market operates under cost-containment regulations there is an eagerness to be at the forefront of technological developments. The market looks to the U.S. for developments in research and application of the newest medical technology. U.S. firms will find that the market is quite receptive to high-quality equipment that offers both ease of use and cost efficiency. Future demand are expected in the following areas Telemedicine Medical informatics Non-invasive surgical equipment Orthopedic and prosthetic equipment and Home health care - equipment and supplies Barriers N/A Global Healthcare Technologies Team Trade Events Swedental Stockholm November 12-14 2009 Dental show swedental.org Riksstamman Stockholm November 25-27 2009 riksstamman.se The Annual General Meeting of the Swedish Society of Medicine is Scandinavia’s biggest meeting place for everyone in the health care industry. Biotech/Scanlab Stockholm November 25-27 2009 scanlab.nu Northern Europe’s leading fair within biotechnology and laboratory equipment. Vitalis Goteborg April 27-29 2010 swefair.se Telemedicine e-health Riksstamman Goteborg December 1-3 2010 swefair.se Annual General Meeting of the Swedish Society of Medicine Available Market Research Telemedicine 2008 Medical equipment 2006 U.S. Commercial Service Contact Information Name Catharina Kronstrom Position Senior Commercial Advisor Email catharina.kronstrom #x40 N0SPAM. trade.gov Phone +46-8-783 53 52 Global Healthcare Technologies Team Switzerland Capital Bern Population 7 604 467 GDP* USD 492.6 billion 2008 Currency Swiss Franc Language German French Italian Rhaeto-Romanic Summary The Swiss market for medical equipment and devices is strong and dynamic. Based on the growth in Switzerland’s aging population combined with new technologies and surgical procedures offering faster recovery for patients the projected annual growth is estimated between 6%-10% over the next few years. In 2007 total imports of medical equipment and devices valued at USD 2.6 billion accounted for about 80% of the total market. Market Entry Hospitals clinics cantonal health departments and MD’s buy directly. There is no central procurement agency. U.S. firms can best sell in Switzerland through a qualified importer and distributor who can also offer after-sales service. Swiss medical importers and distributors are experienced and know how to reach out to the numerous market segments and the end-user trade. Current Market Trends With cost-savings pressure on the Swiss healthcare system a growing trend is a decrease in the length of hospital stays. Monitoring of outpatients will therefore become more important and there will be an increased demand for technologies that decrease hospitalization times and for new innovative products that help quicken recovery and rehabilitation. IT also plays a leading role in medical technology and is one of the sectors with highest growth rates. The infrastructure and expertise required for telemedicine are correspondingly well distributed creating ideal conditions for the further expansion of telemedicine. Main Competitors With an import market share of 33.1% in 2007 the U.S. is the largest foreign supplier followed by Germany with 28% France with 8.3% and United Kingdom with 4% and Italy with 3.96%. The Swiss medtech sector comprises of around 700 firms that are wholly or partly focused on medical technology. Of these 300 manufacture their own products – either under their own brand or as an OEM. Many US-based and other international corporations have chosen Switzerland for their European headquarters. While coordinating international activities from their Swiss base many notable firms also produce complex instruments and devices in Switzerland in knowledge-intensive processes. Global Healthcare Technologies Team Current Demand According to experts therapy systems implants and prosthetics are the fastest growing subsectors. Further market trends are miniaturizing and digital techniques. The average Swiss expects that hospitals will have the latest technology therefore U.S.-made products that are on the cutting-edge of technology will have great market potential. Furthermore there is a growing recognition in the medical community that new innovative technologies often contribute to more economical patient care by helping to reduce the length of hospital stays. Barriers The Swiss import climate is favorable to imports of medical equipment and devices with no major roadblocks. Switzerland has aligned its regulatory requirements over a period of years to those of the European Union. The 1972 Free Trade Agreement between Switzerland and the European Community eliminated customs duties and other trade restrictions for industrial and agricultural products. Free trade is therefore possible for about 90% of the goods of Swiss and EU origin. This free trade is also applicable to the European Free Trade Association EFTA of which Switzerland is a member. Products from the U.S. falling under HS Codes 9018.20 9018.50 9018.90 9019.10 9019.20 9021.10 9021.40 9021.50 and 9021.90 are duty free. There is levied a customs duty on U.S. exported products not benefiting from the European Free trade Agreement under HS Codes 90.20.00 9022.3010 9022.3090 9022.9010 9022.9020 9022.9030 9022.9090 which varies between USD 13-369 per 100 kg gross weight. Moreover a Value-Added Tax VAT of 7.6% is assessed. Trade Events Name of event IFAS October 26-28 2009 Location Zurich Switzerland English language website http // ifas-messe.ch Description Biannual trade fair for medical and hospital equipment. Name of event Nanoeurope August 28-28 2009 Location St. Gallen Switzerland English language website http // nanoeurope Description Annual trade show and conference covering nanosciences and relevant equipment and services. Name of event ILMAC September 21-24 2010 Location Basel Switzerland English language website http // ilmac.ch Description Triennial industrial exhibition and conference for research and development environmental and process technology in pharmaceuticals chemicals and biotechnology. Global Healthcare Technologies Team Available Market Research Dental Market March 2007 Laboratory Equipment amp Scientific Instruments November 2007 Medical Equipment and Devices October 2008 U.S. Commercial Service Contact Information Name Elisabeth Mbitha-Schmid Position Commercial Assistant Email elisabeth.mbitha-schmid #x40 N0SPAM. trade.gov Phone +41-31-357 73 13 Global Healthcare Technologies Team Turkey Capital Ankara Population over 70 million GDP* $906.5 billion est. Currency Turkish Lira YTL Language Turkish Summary Turkey has been a growing market for both the medical products and services sectors. In fiscal year 2008 10.8 billion YTL was allocated to the Turkish Ministry of Health MOH by the Government of Turkey GOT . The Ministry of Health MOH budget for FY 2009 showed a 17.5 % increase compared to that of FY 2008 and reached 12.72 billion YTL. Although health expenditures have been growing over the years medical investments are considered to be insufficient to meet the needs of the population. People resident in metropolitans like Istanbul Ankara and Izmir have better access to medical services whereas in rural settlements only basic curative services are being delivered. The Medical Market in Turkey heavily depends on imports as there are only a limited number of local manufacturers of medical equipment. The market is dominated by products from the EU U.S.A. and China. Clinical laboratory equipment reagents ultrasonic scanning apparatus scintigraphic apparatus optical devices endoscopes and disposables are among the products that are heavily imported from the U.S. The increasing observance of infant deaths and infectious diseases show that basic and preventive health services need to be improved on a national scale. Market Entry Most medical equipment suppliers prefer to appoint national and usually exclusive distributors in Turkey. The distributor/importer is knowledgeable about shipping products into Turkey and about building a good reputation with Turkish customers. Currently a large majority of U.S. manufacturers use exclusive distributors to export to Turkey. Prospective agents should be selected on the basis of their organizational and technical ability to support a manufacturer's products in Turkey's own unique national environment. They should be evaluated over time to be sure that they have also earned the respect of customers. The distributor is responsible for advising the manufacturer about the customers' preferences and specific sales requirements. In interviews with hospital buying offices in Turkey a manufacturer's performance was equated with the performance of its distributor. In short a good distributor is the single most important key to success in this market. The critical need therefore is to be cautious in the selection of a Turkish distributor. Due to the critical geographic location of the country Turkey is the main gate the Eurasian Region. Through joint ventures or other types of partnerships American companies can tap the demand in the emerging markets of the Eurasian Region. A number of local Medical Device Manufacturers express their interest in forming partnerships with the American manufacturers to penetrate the growing demand in neighboring countries. Global Healthcare Technologies Team Current Market Trends The following medical devices constitute the best growth prospects for the American companies disposable products advanced med/surgical equipment including angio-cath facilities radiology pathology electronic diagnostic equipment optical devices parts and components of medical devices electronic instruments and appliances for physical and chemical analysis vaccines orthotic and prosthetic equipment and OR/ER systems. Main Competitors Competition comes mainly from the EU countries China and India. Current Demand Disposable products advanced med/surgical equipment including angio-cath facilities radiology pathology electronic diagnostic equipment optical devices parts and components of the medical devices electronic instruments and appliances for physical and chemical analysis vaccines orthotic and prosthetic equipment and OR/ER systems. Barriers The regulatory environment is similar to the EU except for the fact that Turkish Government tends to be stricter with the inspections done at the customs as there is no post market surveillance system in place. In addition to CE marking related requirements all medical products imported to Turkey should bear a product number called "barcode" which is required by the Ministry of Health as part of the registration process. 1 EAN 13 Code UPN The EAN 13 code is required by the Turkish Social Security Institution for reimbursement. The EAN 13 number for a particular product has to be registered by the exclusive distributor of that product in Turkey. The reason for this requirement is to make the post market surveillance process less complicated as the Social Security Institution in Turkey recognizes only one party/importer/distributor that can be held liable for the malfunctions of a particular product. This means the same product number cannot be entered into the system more than once. The sub dealers cannot carry out the registration process as it is solely the responsibility of the exclusive distributor. 2 Translation of User Manuals into Turkish The user manuals of the medical devices have to be translated into Turkish. The translation should be done in the U.S. by a notarized translator. 3 Translation of Labels into Turkish The product labels have to be in Turkish. If the instructions on the labels are clear e.g. universal symbols translation is not required. Global Healthcare Technologies Team Trade Events Name of event Medist 2009 Location Istanbul English language website http // cnr-medist /content/en_index.asp Description The event takes place at the intersection points of global trading in Istanbul and has been marked as a meeting platform for medical device manufacturers/exporters service providers head doctors academicians directors of healthcare centers distributors and importers/purchasing authorities from public and private hospitals. Name of event EXPOMED - International Istanbul Medical Analysis Diagnosis Health Care Hospital Supplies and Rehabilitation Aids Fair Location Istanbul Date March 2009 - repeats in April/May every year. Date for 2010 TBD English language website http // tuyap .tr/webpages/expomed/index.php main=basin Description The largest medical equipment expo in Turkey and is comprehensive of all types of medical equipment and materials. About 1 500 companies display every year from around 50 countries. The number of visitors in 2009 was approximately 30 000 mainly composed of buyers from Turkey Central Asia and neighboring countries. 95% of the visitors surveyed noted that they will be visiting this expo next year too. Name of event LABTEK - International Istanbul Laboratory Technology and Equipment Fair Location Istanbul Date March 2009 - repeats in April/May every year. Date for 2010 TBD takes place in conjunction with EXPOMED English language website http // tuyap .tr/webpages/expomed/index.php main=basin Description The largest laboratory equipment expo in Turkey and is comprehensive of all types of laboratory equipment. About 1 500 companies display every year from around 50 countries. The number of visitors in 2009 was approximately 30 000 mainly composed of buyers from Turkey Central Asia and other neighboring countries. 95% of the visitors surveyed noted that they will be visiting this expo next year too. Available Market Research Please CS Turkey’s website at buyusa.gov/turkey/en U.S. Commercial Service Contact Information Name Ms. Ozge Cirika Position Commercial Specialist Email ozge.cirika #x40 N0SPAM. trade.gov Phone +90-312-457-7169 Name Ms. Ebru Olcay Position Commercial Specialist Email Ebru.Olcay @mail.doc.gov Phone +90-212-335-9223 Global Healthcare Technologies Team Ukraine Capital Kyiv Population 46.38 million GDP2007 $ 140 billion Currency Hryvnya Language Ukrainian Summary The Ukrainian medical equipment market was estimated at 470 million dollars in 2008 and imported equipment dominates. The major exporter to Ukraine is Germany. Experts estimate that due to the financial crisis and the current unstable exchange rate imports will decline. Medical equipment traders are prime contacts for U.S. businesses entering the Ukrainian market due to their extensive networks and ability to identify buyers. The Ukrainian market is receptive to advanced medical equipment offering ease of use and cost savings. Receptivity to used medical equipment is average – on the one hand there is a demand from end-users but on the other hand used equipment cannot be purchased through government tenders. However a potential market for used medical equipment exists with a preferred approach for locating direct sales opportunities private hospitals and clinics rather than sales through distributors. Market Entry U.S. companies entering the Ukrainian market should approach with a long-term perspective. Business in Ukraine is often based on relationships so selecting a good local partner and/or establishing a local office are crucial to long-term success. To find a potential partner we recommend the Commercial Service’s International Partner Search and Gold Key programs to conduct initial screening. For more details please refer to http // buyusa.gov/ukraine/en/8.html U.S. companies should use appropriate due diligence in selection of partners and should be mindful of the parameters of the Foreign Corrupt Practices Act. Kyiv is not the only hub of trade in Ukraine. Look for distributors that have nationwide capabilities including those located in the cities of Dnipropetrovsk Donetsk Lviv Odessa Zaporizhzhya and Kharkiv. These regions are considered important industrial centers of Ukraine and are densely populated. Covering the Ukrainian market from regional offices in Poland or Russia is not effective. An on-the-ground presence is crucial to business development here. Joining the American Chamber of Commerce and obtaining experienced legal and accounting support are other helpful basic steps. While many U.S. firms have experienced marked success here Ukraine is not a market for the first- time exporter. Companies doing business here must develop a tolerance for uncertainly and the persistence to overcome obstacles to doing business. Global Healthcare Technologies Team Current Market Trends The following areas have the best sales potential in Ukraine • Modern equipment offering ease of use and cost savings in the fields of microsurgery radiology and biomedicine • Laboratory equipment i.e. centrifuges ultracentrifuges spectrophotometers nuclear counters blood grouping systems and diagnostic kits • Dental equipment i.e. complete workstations dental syringes needles and laboratory products • Diagnostic systems and disposable items. The Ministry of Public Health priorities for its current work with WHO are HIV/AIDS Tuberculosis and Mental Health. These choices were apparently based on the size and severity of the burden in Ukraine the risk of diseases spreading to more people and the availability of international assistance. In September 2007 the Government of Ukraine announced a 7 – year program to modernize medical equipment in the Ukrainian state-owned healthcare system. Main Competitors Looking at the dynamics of foreign medical manufacturers’ penetration of the Ukrainian market it can be seen that European and Japanese firms are more aggressive than their American competitors. They were the first to establish representative offices and focus on Ukraine as a separate market. Domestic medical equipment production is not competitive on a global scale. Current Demand The Ukrainian market is receptive to high-quality advanced diagnostic and therapeutic equipment. Innovative technologies such as laser-optics in vascular surgery urology gastroenterology dermatology and neurosurgery and new diagnostic devices are becoming more popular. Modern equipment offering ease of use and cost savings is required in the fields of micro-surgery radiology and bio-medicine. Barriers Medical equipment and devices both locally manufactured and imported can be used for medical practice on the territory of Ukraine only after being recorded in the State Register of Medical Equipment and Devices of Ukraine and upon issuance of a registration certificate. Registration is performed by the State Service for Drugs and Medicinal Use Products. According to current regulations government tenders are to be non-discriminatory against foreign bidders with some exceptions granted on a tender-by-tender basis. These exceptions give priority to domestic suppliers. Global Healthcare Technologies Team Trade Events Name of event Public Health Location Kyiv English language website http // publichealth .ua/en/ Description Public Health is the largest medical equipment including dental clinical laboratory and optical and pharmaceuticals trade show in Ukraine with about 400 exhibitors. Public Health 2009 will be held in Kyiv on October 13-16 2009 at the International Exhibition Center. The show organizer for Public Health is Premier Expo a part of the International Trade Exhibitions Group UK. U.S. Commercial Service Contact Information Name Olena Stephanska Position Commercial Specialist Email olena.stephanska #x40 N0SPAM. trade.gov Phone 380-44-4904054 Global Healthcare Technologies Team Argentina Capital Buenos Aires Population 40.3 million GDP* $261 billion 2007 Currency Peso ARS Language Spanish Summary Healthcare expenditures in Argentina are approximately $6.1 billion or about 3 percent of GDP. Measures such as import duty exemptions to alleviate cost burdens on importers and ultimately the end-users are resulting in a continuous flow of critical imported products. While the healthcare market has not completely recovered from the economic crisis of 2001/2002 medical products that cannot be produced locally continue to be a best prospect sector for U.S. exporters. The United States continues to lead the import market and currently holds 33 percent of the market share particularly in higher-end technology products. Imports in the overall medical product sector have traditionally accounted for almost 75 percent of the total market. U.S. companies that offer high quality products at competitive prices can find niche opportunities in the Argentine market. Market Entry Imports of medical products must be performed by an importer registered with the ANMAT the Argentine equivalent to the FDA as a frequent importer of medical equipment. Imported products appear under the name of the local registered importer who will be responsible for the products and the registration process as a representative of the U.S. Company. Requirements vary according to product classification. For countries outside the MERCOSUR area Argentina and its Mercosur partners Brazil Uruguay and Paraguay established the Mercosur common external tariff CET on January 1 1995. The CET currently ranges from zero to 16 percent for medical products plus 0.5% in statistics fee. However legislation in force until end of 2009 exempts imports from non-Mercosur countries from tax and duties on some critical new medical and lab equipment instruments disposables implants diagnostic reagents and pharmaceuticals that cannot be supplied by Argentine manufacturers. In addition under the Capital Goods Law a zero percent import duty for capital goods produced in non- Mercosur countries will remain in effect until January 1 2011. Current Market Trends The market has been growing rapidly in the past four years gradually approaching pre-devaluation import levels although the total market size has decreased in dollar terms due to the devalued peso. The rising trend of imports from the United States that started with a peak growth in 2005 a 65% growth versus 2004 figures and an 18% increase in 2008 versus 2007 figures will continue although at a lower and more stable rate during 2009. Imports of medical equipment devices and instruments were estimated to account for approximately $515 million in 2008 with the United States comprising $165 million of this segment. The import market for diagnostic reagents and clinical lab represents over $250 million and the dental market an additional $25 million approximately. Global Healthcare Technologies Team Main Competitors More than two thousand companies sell medical products and equipment in Argentina of which 25 percent are manufacturers and 75 percent are importers. Brazil poses strong competition since imports enjoy a 0 percent import duty under Mercosur. U.S. Japanese and European-made equipment is known for its high technology and precision whereas Argentine equipment although durable is generally low-tech. Domestic production is limited to basic x-ray devices and peripheral equipment such as illumination systems furniture operating tables ecographs and ECGs monitors oximeters cobalt pumps anesthesia equipment sterilization equipment basic lab equipment instruments for arthroscopy fixation instruments for video endoscopy surgery wheelchairs scales etc Current Demand American companies can take advantage of a more competitive U.S. dollar versus the Euro by offering good quality at competitive prices. Given that most international brand names are already in the market local companies are eager to obtain quality products at a more competitive price. Simpler technology is more easily financed and thus considered mass-market goods. In this competitive market the demand for these products is mostly met although there is still room for new players to enter with niche products. Niche opportunities for U.S. exports include implants specialized disposables lab and diagnostic equipment among others. Components and medical equipment parts offer a strong sales-potential in large part because of the fact that the market conditions require the reconditioning of equipment already in use. Barriers Restrictions apply to imports of used medical equipment. Scarce financing available at the local market is an issue. Trade Events Event Expomedical 2009 Place Centro Costa Salguero Buenos Aires Webpage expomedical .ar Description international exhibition of medical equipment products and supplies. Parallel seminars. Available Market Research Medical Disposables July 2007 Medical Instruments May 2007 Medical Equipment and Devices August 2006 Dental Equipment and Supplies June 2006 Clinical/Analytical Laboratory Instruments and Reagents August 2005 U.S. Commercial Service Contact Information Name Liliana Paz Position Commercial Specialist Email liliana.paz #x40 N0SPAM. trade.gov Phone +54-11-5777-4519 Global Healthcare Technologies Team Brazil Capital Brasilia Population 190 million GDP* 1.5 trillion Currency Real Language Portuguese Summary Brazil is the largest medical equipment market in South America. It is expected that sales of medical equipment and devices will reach US$7 billion in 2009. The total market for medical equipment in Brazil should continue to expand through 2009. Brazil is both a major medical equipment producer and importer. This industry is comprised of a number of related products and services including o Medical equipment and devices. o Dental equipment and products. o Radiological and diagnostic imaging equipment. o Laboratory equipment. Market Entry In addition to the attractive size of the Brazilian medical market US exporters should consider the opportunities offered by Mercosul and use Brazil as a "spring board" for export into Argentina Uruguay and Paraguay. Since compulsory product registration before sale is required for all of Mercosul countries US exporters should consult a local lawyer/consultant before signing a contract with any agent/distributor. Current Market Trends An interesting trend in Brazil is the growing market for home health care products which has increased dramatically in recent years. Brazil has approximately 150 home health care companies compared to approximately 1 440 in the US. In Brazil these companies are increasingly viewed as good ways to cut hospitalization costs while offering better services for patients. Brazilian health insurance companies are responsible for paying 99% of the costs related to home care treatment and as such the U.S. Commercial Service sees the market for home health care products growing dramatically during the coming years. Brazil’s Regional Nursing Council is currently developing procedures on how to regulate this market including standards for health professionals. Main Competitors There is a strong and solid local manufacturing of medical products and disposables in Brazil. Even international companies such as GE BD Phillips and Siemens have some plants in Brazil as a strategy to reduce import costs and to use the country as a regional center of distribution of medical devices. Global Healthcare Technologies Team Current Demand Brazil’s recently strengthened currency has meant that private and public hospitals have greater purchasing power and with continued expansion of Brazil’s private health care sector the market should grow. New opportunities for US exporters abound particularly for o More advanced medical equipment. o Disposables. o Diagnostic devices. o Implants and components. Barriers The registration of medical equipment and devices is imposed and controlled by the National Health Administration Agency – Agência Nacional de Vigilância Sanitária usually referred as ANVISA created in 1999. The agency has enforcement powers similar to FDA including cancellation of operation permits for drugs food medical and cosmetic products and licensing of manufacturers and distributors. No product without clinically or therapeutically proven beneficial substance in its composition can be registered with the ANVISA. For registration purposes both local manufactured and imported products must inform detailed information about the products such as their internal structure and components. Trade Events List 2009 and 2010 events Name of event Dental Show January 2010 Location São Paulo Name of event Hospitalar May 2010 Location São Paulo English language website hospitalar Description Hospitalar is the second largest medical event in the world with more than 1 200 exhibitors. The show is focused on medical equipment and devices in vitro diagnostic products rehab and dental. Available Market Research For further market research for healthcare industries visit the website focusbrazil.org.br/siteUSA/index.htm U.S. Commercial Service Contact Information Name Jefferson Oliveira Position Business Development Specialist Email jefferson.oliveira #x40 N0SPAM. trade.gov Phone 55 11 5186-7136 Global Healthcare Technologies Team Canada Capital Ottawa Population 33 Million GDP* 1 523 216 C$ Millions Currency Dollar Languages English amp French Summary Strictly regulated and different the Canadian market for medical equipment offers excellent opportunities for U.S. exporters. Demand is strong for technologically advanced equipment particularly for diagnostic and patient monitoring applications. The market is valued at US$6.6 billion. U.S. suppliers occupy more than 50% of all imports representing a value exceeding US$2.3 billion. Market Entry The sale and use of medical devices is strictly regulated in Canada by an FDA equivalent called Health Canada. Health Canada's Therapeutic Products Program TPP ensures the safety and effectiveness of medical devices. Medical products or devices are classified into four categories depending on the level of potential risk to the patient. Class I represents devices that pose the least risk while Class IV pose the highest risk. Licenses are delivered for each product or category of product in Class II III and IV. Current Market Trends Demand for diagnostic and patient monitoring equipment will lead the growth in sales of medical equipment over the next two years in Canada 2009-2010. The increase in demand for all types of electro medical equipment will be led by technologies including nuclear medicine cameras MRI magnetic resonance imaging and CT computed tomography . Other medical electro-diagnostic and patient monitoring equipment including ultraviolet and ultrasonic scanners will also benefit from increased demand. The average real growth of Canadian demand value for all medical equipment and supplies during the 2009 and 2010 period should remain relatively strong with annual increases of between 8 and 9 percent. Main Competitors Same as U.S. Market 2007 2008 2009 Current Demand Market Size 5586 6124 6651 Local Production 2729 2960 3167 Exports 768 860 942 Imports 3625 4024 4426 Imports from U.S. 1991 2185 2349 Millions of U.S. dollars unofficial estimates exchange rate US $1.00 = CDN $1.00 Global Healthcare Technologies Team Barriers No significant barrier other than Canada having its own licensing regulations Trade Events Health Achieve 2009 Toronto November ohahealthachieve Available Market Research 1Home Care Market Demand for home care products and services In Canada is expected to continue to expand rapidly in the coming years offering superb opportunities to U.S. firms particularly for products offering the latest advances in technology and design. Home care s undoubtedly an important component of Canada’... Canada - 03/27/2009 1Canada- Laboratory Electrical Optical Equipment The Canadian market for Laboratory Electrical Optical Equipment is booming and despite the current economic downturn is expected to continue to expand. Technological advances have allowed greater utility and ease of use of old equipment through accessories add-ons and computers while advances in m... Canada - 03/16/2009 1Dental Equipment amp Supplies Although Canada is a country well known for its publicly funded universal health care system it does not include dental care coverage except under conditions requiring hospitalization. Canadian dentistry is essentially a private sector market with a demand for professional dental equipment and sup... Canada - 01/07/2009 1Natural Health Products The Canadian market for natural health products NHPs has continued to grow at a rate of seven percent per year and in line with increasing consumer interests and demand. This report endeavors to provide insight into current market trends and regulations affecting U.S. exports of vitamins and mine... Canada - 10/02/2008 1Infection Control Market in Canada The import-driven US$ 1.5 billion infection control market in Canada offers export opportunities to U.S. manufacturers of infection control products. Infection control products include sterilizers autoclaves personal protective wear and equipment sanitizing gels and disinfectants for rooms and ot... Canada - 12/05/2007 1Medical Imaging Market in Canada The Canadian market for new medical imaging equipment is estimated to be US $1.6 billion. Demand has grown at an average annual rate of 7 percent over the past five years. It is expected to grow between 5 and 10 percent through 2010. Digital radiography equipment and position emission tomography PE... Canada - 12/05/2007 Global Healthcare Technologies Team U.S. Commercial Service Contact Information Name Pierre Richer Position Commercial Specialist Email Pierre.richer #x40 N0SPAM. mail.doc.gov Phone 11-514-398-9695 Ext 2261 Global Healthcare Technologies Team Chile Capital Santiago Population 16 454 143 GDP* $187 billion Currency Peso Language Spanish Summary Chile spends approximately 7 percent of its GDP in healthcare. The project “Universal Access with Explicit Guarantees” started in 2005 – ensuring government-funded healthcare coverage for individuals regardless of age class and ability to pay. It currently covers 56 diseases in a wide variety of specialties including mental illnesses. This project should expand to 80 diseases by 2010. In Chile approximately 70% of the population is covered by the public healthcare system while the remaining 30% is covered by 8 private health insurance companies. The total market size for medical equipment reached $187.6 million in 2008. Total imports represented $171.1 million of which the U.S. has a 36% market share. Although in Chile the laboratory equipment and IVD reagents market is small and extremely competitive it is a good and growing market especially for novel equipment. The Chilean market for laboratory equipment grew from US$ 77M in 2007 to US$ 85.2M in 2008 and the market for IVD reagents grew from US$60M in 2007 to US$72.8M in 2008. Market Entry Since the implementation of the Free Trade Agreement between the United States and Chile in 2004 most U.S.-made medical equipment and devices enter Chile duty-free provided a Certificate of Origin is presented to Chilean Customs. Medical imports like all foreign and domestic products are subject to Chile’s 19 percent VAT Value Added Tax . Importers of laboratory equipment and IVD reagents need comprehensive manuals with complete product information ideally in Spanish technical instructions training and good end user support. Product brochures and catalogs that keep users up-to-date about new products and equipment are an on-going requirement. Current Market Trends U.S. medical equipment and devices are well represented in the market including major well known brands. The great receptivity for U.S. medical equipment and in general for medical products is due to the traditionally good reputation that U.S.-made products have established based on quality and excellent after-sales service. Many Chilean physicians have been trained in the U.S. giving U.S. products good exposure. In a country as distant as Chile reliable delivery is crucial. Customer service and personalized attention are highly considered. The Chilean market for Laboratory equipment and IVD reagents is highly competitive. The market trend is currently looking at state-of-the-art equipment and testing devices. Global Healthcare Technologies Team Main Competitors According to 2008 medical equipment and device statistical data the United States has a 36% market share followed by Germany with a 15% market share and Japan with a 7% market share. Price is an extremely important factor especially in the public sector where limited funds cover a large segment of the population. The private healthcare providers are also price sensitive but are far more likely to consider well-known brands that have good quality and after sales reputation. The United States has been for years Chile’s most important supplier of laboratory equipment and IVD reagents. U.S. companies hold about 38% of the IVD reagents market followed by Germany with 25% of market share. In the laboratory equipment market the U.S. has a 28% of the market share followed by Germany with a 19%. Current Demand The Ministry of Health is undergoing a major improvement of its hospital infrastructure that will require an investment of approximately $600 million in high quality equipment and infrastructure for the next five years. Investment includes the construction and remodelling of 35 hospitals 11 of which will be new. Private healthcare providers also have expansion plans that will open good opportunities for U.S. exporters. Barriers Regulations in Chile require that the following medical devices - condoms gloves syringes and needles be quality tested by a Chilean authorized testing facility before marketing authorization is granted. Trade Event Salon Dental Santiago Chile Website salondentalchile.cl Spanish website Salon Dental is an annual international trade show for the dental industry. Available Market Research Chile Dental Industry Overview 2009. U.S. Commercial Service Contact Information Veronica Pinto Commercial Specialist veronica.pinto #x40 N0SPAM. trade.gov Industries Medical dental biotechnology cosmetics nutritional supplements health IT healthcare consulting services and pharmaceutical. Phone 56-2 330-3369 Claudia Melkonian Commercial Assistant claudia.melkonian #x40 N0SPAM. trade.gov Industry Laboratory/testing equipment veterinary equipment. Phone 56-2 330-3312 Global Healthcare Technologies Team Ecuador Capital Quito Population 13 969 915 GDP* $52.5 billion 2008 estimate Currency U.S. Dollar Language Spanish Summary One of the primary goals of the Government of Ecuador is to strengthen healthcare services. In this context the Government has increased the budget for public health and in 2007 declared the sector in emergency to expedite the purchase of medical equipment instruments and supplies. The market for medical equipment instruments and supplies is mainly served by imports. Domestic production is limited to basic metal furniture and basic disposable supplies. U.S. products are well regarded due to their high performance which has contributed to the U.S. being the main supplier. There are no trade restrictions however certain health requirements are mandatory. Current Market Trends Uncertainty has characterized Ecuador’s economic and political activities since 2007. Economic activities have entered into a wait and see period therefore investments are minimal. Ecuador is currently facing a severe crisis due to a deficit in its balance of payments. The Government of Ecuador has responded by taking protective measures including tariff increases and import quotas which the World Trade Organization WTO is examining to ensure compliance with Ecuador’s international obligations. The measures are intended to be temporary they will last for one year and apply to all trading partners alike including those that have preferential trade agreements. The Government of Ecuador will review the measures within the year and determine if they are to be dropped or extended. None of these measures affect the import of medical equipment instruments and supplies. The Ministry of Health is responsible for the establishment of health plans national health strategies and the provision of integral health services and environmental activities. Constant cuts in government budgets expansion of the payroll inefficiency in the organization and provision of medical services strong union presence and fragmented authority have all limited and seriously affected the public sector’s participation in health provision. Approximately 85 percent of the population has access to health care services. The public sector serves 42 percent of the population while the private sector covers 43 percent of Ecuadorians. The budget for the public health sector is USD 837 million for 2009. The current administration fosters the development of social programs. Therefore it has destined more funds to the health sector than any other government. Its goal is to provide free healthcare services to the population. Global Healthcare Technologies Team Market Entry It is strongly recommended to utilize a local representative or distributor to assist with local requirements and relations. Business in Ecuador is mostly conducted through agents and distributors who will assist in promoting/retaining the product in the market. When appointing a local distributor U.S. firms should seek counsel from an Ecuadorian law firm to ensure that their distribution agreements give them appropriate protection. It is advisable to appoint non-exclusive representatives for a limited period of time and to include an arbitration clause as a means to resolve any disputes that may arise. The U.S. Dollar is Ecuador’s official currency. At the present time typical terms of sale are either a down payment or advance cash payments. In the case of a long-standing relationship individual payment plans and schedules are more flexible. Most distributors cover the whole country and use their own sales forces. Imports into Ecuador require an import permit issued by any bank registered with the Central Bank. Medical equipment instruments and supplies are subject to an import duty ranging between 0 to 20 percent depending on the type. In addition a 0.5 percent tax for the Children’s Development Fund and 12 percent value-added IVA tax are also required. These charges are based on the CIF value of the merchandise. Ecuador has negotiated exceptions under the Andean common tariff that allow for lower duties. U.S. firms may wish to take advantage of this circumstance to distribute their products from Ecuador to Peru Colombia and Venezuela. Depending on the type of products either price and/or quality are the key factors when making the final purchase decisions. Quality being a synonym for safety and savings is the key factor in purchasing electro medical equipment. Price is a factor when purchasing by volume and when the quality of the items being purchased is the same for all brands quoted. Certain disposable items such as surgical head caps and boots where quality is not indispensable are purchased by price. Surgical gloves however are purchased by quality. Given the financial constraints public hospitals generally focus on price. Main Competitors The U.S. is the major supplier. It accounts for an estimated 41 percent overall share of the market. The estimated U.S. market share for medical equipment is 47 percent for instruments 25 percent and for disposables 30 percent. Main competitors are Germany image segment and instruments Japan video endoscopy Pakistan instruments South Korea France Holland Italy echosonography Brazil Malaysia China and Colombia disposable supplies . Best Prospects Best prospects for equipment include laser apparatus for non-invasive surgery MRI laser electro-surgical units laser for ophthalmology and urology multi-parameter patient monitors dental laser ultrasound echographs for gynecology adult amp pediatric incubators and ventilators. Best prospects for medical disposable supplies include syringes IVs needles gloves gauze bandages sheath contraceptives adhesives and catheters for heart surgery. Best prospects for instruments included diagnostic kits scales and ophthalmoscopes. Global Healthcare Technologies Team Barriers There are no trade barriers as such. However there are several import requirements as follows Import of medical disposable products and certain types of equipment are subject to authorization from the Ministry of Health and require a Sanitary Registration Certificate. Current legislation allows for the mutual recognition homologation of sanitary registration certificates and the presentation of certificates of free sale from countries approved by the Ministry of Health. Anesthetics require prior authorization from the Ministry of Health and the National Drug Council CONSEP while X-ray equipment and supplies require authorization from the Ecuadorian Atomic Energy Commission prior importing. INEN the Ecuadorian Standards Institute requires that medical supplies in packages including sample products bear a label in Spanish. U.S. Commercial Service Contact Information Name Amparo Meneses Position Commercial Assistant Email amparo.meneses #x40 N0SPAM. trade.gov Phone 011-593-2-3985463 Global Healthcare Technologies Team El Salvador Capital San Salvador Population 5.7 million GDP* $22 billion Currency US Dollar Language Spanish Summary The Salvadoran health sector is composed of the public sector that consists of the Ministry of Public Health and Social Assistance MSPAS the Salvadoran Social Security Institute ISSS the Salvadoran Integral Rehabilitation Institute ISRI Teachers Welfare and the Military Health Service and the private sector that includes hospitals clinics and non-profit organizations. As of 2005 the Ministry of Health reported a national network of 625 services consisting of 30 hospitals 3 of Third Level 27 of Second Level 369 health units 170 health homes 51 rural nutrition centers 3 clinics of the Salvadoran Institute for the Integral Development of Children and Adolescents ISNA and 2 emergency centers. The Salvadoran Social Security has 11 hospitals 32 health units 33 community clinics 197 corporate clinics and 1 physician health unit. The ISSS provides coverage to workers in the private enterprises and government employees along with their respective beneficiaries. In the private system hospitals and clinics are concentrated in the country’s three main departments San Salvador Santa Ana and San Miguel. Market Entry The local hospitals and clinics prefer products with high quality competitive price durability maintenance and availability of spare parts and accessories. Post-sale service is very important. Additionally to allow operators to easily handle the equipment operating instructions and manuals are preferable in Spanish as well as product brochures and literature. To enter the market a U.S. company needs a legally appointed distributor or representative in the country. It is recommended that the U.S. Company work closely with a local partner to have effective promotion strategies and continuous presence in the market. Selling to public institutions implies participation in public bidding processes. Current Market Trends The Salvadoran medical equipment market relies on imports as local production is limited to hospital furniture. The public sector is the key primary purchaser of medical equipment and supplies through the Ministry of Health and the Salvadoran Social Security Institute. Public institutions differ from private entities as they only buy new equipment. Some private hospitals can occasionally acquire used or refurbished equipment however this type of equipment is preferred by small clinics and hospitals. Global Healthcare Technologies Team Main Competitors The U.S. is the main exporter of medical products to El Salvador with 51% of the market share. The main competitors are products coming from Germany Mexico China and Japan. U.S. products are preferred for quality training programs competitive price and geographic proximity which facilitate the rapid shipment of spare parts. In 2006 the U.S. exported $24 million in medical equipment instruments and disposables to El Salvador. Current Demand Best prospects for U.S. companies are for the following products • Electro-medical instruments • Diagnostic imaging equipment • Cardiac monitors • X-ray equipment • Oxygen therapy and artificial respiratory ventilators • Ultrasonic scanning equipment • Magnetic resonance imaging apparatus • Computerized Axial Tomography Scanners CT apparatus • Beds lamps Other opportunities within the industry lie in the following products • Syringes with or without needle parts and accessories • Catheters • Gloves bandages for medical use Government tenders are posted in the procurement official website comprasal.gob.sv . Barriers There are no trade barriers for the importation of medical equipment into El Salvador. The Salvadoran market is approximately 80% for new equipment and 20% for used and refurbished. The importation of medical equipment is not restricted and no tariffs are applied except for the 13% value added tax. Trade Events No local shows. Available Market Research http // buyusainfo.net/adsearch.cfm search_type=int amp loadnav=no U.S. Commercial Service Contact Information Position Commercial Assistant Email lidia.sosa #x40 N0SPAM. trade.gov Phone 503 2501-3211 Global Healthcare Technologies Team Guatemala Capital Guatemala City Population 13 000 000 gt GDP* USD 67.007 Billion Estimate 2008 Currency Quetzal Language Spanish Summary The market of medical products in Guatemala reached USD51 million in 2008 it decreased around USD 13 000 000 from 2007 due to the world economic crisis. Guatemala is a country of over 13 million inhabitants with high levels of poverty that require assistance by the public sector for health care. Those who can afford to will stay away from public sector options and opt for private hospitals or clinics. The market of medical services is divided in two segments the private and public sectors. o The private sector as a common rule purchases only well known brands of medical equipment because of their appreciation of high quality products and available customer support from the distributor in any emergency. Investments in new medical equipment within the private health care sector are expected to continue. New clinics and current hospitals buy periodically to fill their equipment needs and continue to invest strongly in new technology for diagnostic and treatment equipment. o The Government on the other hand is price driven and will purchase from the lowest cost provider. The ruling party in Guatemala UNE and the current president Mr. Alvaro Colom define their government as a social democracy hence invest in social projects for the poor. Recently the president announced that all medical services in public hospitals and clinics will be free of charge to any patient. This means major hospitals are replacing older equipment and buying new equipment that can meet the demand of free medical services for all of the population. The public sector consists of hospitals and clinics operated by the ministry of health through the social security institute and the armed forces. Market Entry The most important decision a U.S. company has to make is to choose a local representative. The best strategy is to screen potential importer-distributors and select the most qualified. The chosen importer should be a company that is registered to sell to the government and can participate in official tenders and bids. Also this company needs to know the private market and have constant communication with the purchase manager of hospitals clinics and medical doctors with practices that use equipment. Once the exclusive representation is given to a Guatemalan importer it is difficult to take it back because of the representation law in Guatemala. It is necessary to have a good relationship and chose the correct representative. The legal system can be slow and the law under certain conditions offers local agents a great deal of protection. Formal agency or distribution agreements should be reviewed by a Guatemalan attorney hired by the U.S. exporter independent of the Guatemalan party with which the agreement is being established . Global Healthcare Technologies Team Current Market Trends • Preference of local consumers The preference of Hospitals and clinics for medical equipment is based mostly on o Brand name o Specifications of the equipment o After sales and training of the end user o Latest technology or world trend • Demand of differentiated market The final consumers or end users of medical equipment are all the private and public hospitals and clinics in Guatemala. The difference between both markets is that private customers buy immediately and often look for the best brand of equipment meanwhile public purchases are made by bids all year long and are informed by the Government via their website in charge of bids guatecompras.gt . Main Competitors The competing countries are many and it depends on the specifications and purpose of each piece of equipment but in general the United States of America is the most important exporter of medical equipment to Guatemala with an approximate 60% share of the import market. Germany is the second major exporter to Guatemala but is showing a decrease in almost all the categories of HS codes due to the high prices of the German brands and because they export their medical equipment directly from the USA because it is more convenient for delivery time. Japan and China are in third place depending on the HS code and each one with different features of price and quality in their products. Global Healthcare Technologies Team Current Demand The total number of Hospitals in Guatemala is approximately 166 and the total number of clinics is 2 372. There is no official data for the number of hospitals in the private sector. The ministry of health only keeps records for the public sector. The private health care system consists approximately of • 106 Hospitals • 1387 Clinics The public health care system consists of • 66 Hospitals 23 Belong to the social security institute • 985 Health clinics 18 Belong to the social security institute All of the hospitals will need to purchase equipment in the future. The medical field is constantly replacing equipment for the following sectors radiology mammography MRI scanners patient monitoring systems digital image processing clinical laboratory equipment and dialysis equipment. These will be purchased periodically by most of the hospitals and clinics in Guatemala depending on each necessity. Medical equipment is constantly evolving and utilizing sophisticated products. Most end users are looking for new technologies and prefer user-friendly features in medical machines. Recently end users have requested companies to provide them with instruction manuals in Spanish as well as Spanish labeled buttons on the equipment. Barriers According to the Customs Office of Guatemala there are no non-tariff barriers for the imports of medical equipment because there is no local production. There is no registration required for medical equipment entering the country only pharmaceuticals need to be registered with the Ministry of health. There are no requirements for environment control packing or labeling of medical equipment. Local importers prefer products and brands that have quality control certificates like ISO CE or other. Trade Events In Central America there are no fairs related with medical equipment but most importers travel once a year to the Medical equipment fair in Miami fimesshow to meet with their counterparts and look for new products and trends. U.S. Commercial Service Contact Information Name Antonio Prieto Position Industry Trade Specialist Email antonio.prieto #x40 N0SPAM. trade.gov Phone +011-502-2326-4310 Global Healthcare Technologies Team Mexico Capital Mexico D.F. Population 105 million 2008 estimate GDP US$ Trillion 1.57 2008 estimate Currency Mexican peso Language Spanish Summary Mexico is a big market for all types of medical devices. Imports of medical equipment instruments and disposable products reached US $2.3 billion in 2007. Imports of U.S. products are duty free if they comply with the NAFTA certificate of origin. U.S. products are appreciated because of their high quality and good prices. U.S. companies should take advantage of geographical proximity to start or increase their presence in Mexico. Market Entry All medical equipment and devices can be imported duty free with a NAFTA certificate of origin. Imports are subject to a 15% VAT tax over the invoice value. About 90% of medical equipment and instruments and about 20% of medical disposable products are imported. Medical products of U.S. origin are very appreciated in Mexico because of their high quality after sales service and good price compared to other similar quality products. U.S. exporters of medical equipment and instruments thus have good sales opportunities in Mexico. Current Market Trends Most large public and private hospitals try to have modern and very specialized medical devices. Some medium and small private hospitals with limited budgets buy used or refurbished equipment. Public hospitals by law cannot buy used or refurbished products. In order to save resources recently many public and private hospitals are hiring companies that offer “integral surgery services” and provide service “per event” offering all the necessary products required to perform a surgery. In this way hospitals avoid making large investments in materials pharmaceuticals and instruments and also reduce the costs involved in keeping and controlling inventories and maintaining instruments for specialized surgeries. All public institutions ask suppliers to register with their organization. These institutions may award purchases under US$3 100 directly to a selected provider. Purchases over that amount must be done through public tenders. All private health care facilities select suppliers by requesting price quotations. Their decisions are based on the best equipment at the best price. Main Competitors Most large international corporations offering medical devices have a presence in Mexico. Medium and small foreign suppliers usually sell through legally appointed distributors. Global Healthcare Technologies Team Current Demand Imports supply 90% of the Mexican market for medical equipment and instruments and 20% of demand for medical disposables. In 2007 total imports in these three groups of products reached $2.3 billion. Of these imports 51.1% or 1.2 billion dollars were of U.S. origin. Main competitors are from Belgium Brazil Canada China France Germany Israel Italy Japan Netherlands South Korea and UK. Barriers All medical and health care products that touch or affect the human body need to be registered with the Mexican Secretariat of Health SSA prior to sale or use in Mexico. Foreign manufactures of medical devices need to have a legally appointed distributor/representative in Mexico responsible for the registration process and for the product s in Mexico. To be imported into Mexico some medical products need to comply with technical standards or NOMs Norma Oficial Mexicana . All standards are classified based on the Harmonized System Code HS . There are few Mexican standards for medical devices but various agencies are preparing more standards to be issued in the near future. Updated information on NOMs and other sanitary processes can be found on the web page of the Mexican Secretariat of Health ssa.gob.mx . Trade Events For a list of medical events in Mexico please consult available market research. Available Market Research • Registering medical devices with the Mexican Secretariat of Health January 2007. • Standards for medical equipment May 2008. • Import market for medical instruments May 2008. • Mexican Health Care System June 2008. • Labeling for medical devices September 2008. • Events in the Medical Sector 2009 March 2009. U.S. Commercial Service Contact Information Name Alicia Herrera Position Senior Commercial Specialist Email alicia.herrera #x40 N0SPAM. trade.gov Phone 011-52-55 5140-2629 Global Healthcare Technologies Team Panama Capital Panama City Population 3.3 million GDP* $18.5 billion Currency U.S. Dollar Language Spanish Summary Panama offers good opportunities for Health Service companies. It enjoys the highest per capita income in Central America and has a relatively well developed health care sector. Its hospitals are modern and most leading doctors were trained in the U.S. Panamanians regard the U.S. as the best source for healthcare services and modern medical technology. An increasing number of wealthier Panamanians travel to the United States for medical treatment. Medical centers in Texas and Florida are favorite destinations. This trend will continue because the U.S. offers state of the art treatment especially for cancer and heart disease. Best sales prospects in Panama are hospital administration and design health services management medical treatment in the U.S. and consulting services in the public health area. Foreign companies will find a friendly business environment in Panama with no restrictions or barriers to doing business. Companies with a serious interest in maintaining a long-term presence in the Panamanian market should consider appointing a representative who understands the market the culture the government procurement system and other local conditions. Market Entry There are no import restrictions for health care services in Panama. No barriers exist for foreign companies providing such services except for normal requirements dealing with corporate registration. Medical practice is however restricted to doctors registered with the Ministry of Health and who have obtained the appropriate certification certificado de idoneidad from the University of Panama. In theory foreign doctors can qualify for this certification by taking the required exams in Spanish at the University of Panama and by complying with Panamanian immigration laws. In practice few foreign doctors practice in Panama. Leading doctors in Panama normally belong to professional associations in the U.S. and to local associations in their respective specialties. Regarding medical equipment the public sector requires certification of equipment which is done by the Ministry of Health and the Social Security organization. The private sector has no restrictions to buy medical equipment. Current Market Trends The U.S. is the prime supplier of medical equipment supplies and related products to Panama. It is also the main supplier of health care services. Services provided by U.S. suppliers include medical treatment in U.S. hospitals training for Panamanian doctors in the U.S. technical training for use of U.S. equipment and consulting services for the public sector. Estimates indicate that Panamanians spend about $6-8 million annually on medical services in the U.S. Global Healthcare Technologies Team Main Competitors Spain has recently been active in the medical services sector. A number of Spanish companies have participated in bids for hospital construction and administration and procurement of medical equipment. Due to availability of export credits from the Spanish Government these companies have been able to secure a number of projects for hospital construction and to sell substantial amounts of equipment both in Panama City and the interior. Colombia is another competitor especially for ophthalmologic treatment. Colombia has the potential to become a major competitor in other medical areas because it offers excellent medical facilities at reasonable prices. French companies were involved in the past in hospital design and equipment but have not been active in the recent past. Current Demand The Ministry of Health and the Caja del Seguro Social have been traditional users of imported health care services medical equipment and consulting services. Most of these services have been financed by multilateral development organizations. The Caja del Seguro Social is always modernizing its services to make them more efficient and cost- effective. Affiliation with the social security system is mandatory for all Panamanian workers. There are approximately 600 000 workers affiliated with the CSS and a total of 1.9 million persons covered by the CSS health system. This amounts to almost 60% of the country's total population of 3.3 million. The Ministry of Health is implementing a new model of hospital management by which groups of private individuals or boards patronatos are responsible for the administration of hospital services and resources. Barriers Panama has no significant trade barriers for health products or services. Panama is considered to have one of the most open economies in the region. Trade Events Name of event Expocomer 2010 Location Panama City English language website expocomer Description This is Panama’s largest trade show that covers a number of sectors including health services and equipment. U.S. Commercial Service Contact Information Name Enrique Tellez Position Commercial Specialist Email enrique.tellez #x40 N0SPAM. trade.gov Phone 507-207-7080 Global Healthcare Technologies Team Uruguay Capital Montevideo Population 3.3 million GDP* 32.2 billion 2008 Currency Uruguayan Peso Language Spanish Summary Uruguay imports almost all its medical equipment. Major market opportunities are for new technologically advanced supplies and equipment particularly in the areas of non-invasive procedures ultrasound magnetic resonance imaging and CT scans. All products must be registered with the Ministry of Public Health by a local representative. The Commercial Service in Uruguay can assist U.S. firms find their local business partner. Market Entry Uruguay and its MERCOSUR founding partners Argentina Brazil and Paraguay established a common external tariff CET on goods originating in non-member countries that currently ranges from zero to 20 percent for most products including medical equipment and supplies. Approximately 35 percent of Uruguay's total medical equipment imports are for the public sector and 65 percent are for the private sector. Customs duties and other taxes for medical equipment range from 0 to 20 percent. The only products that require special processing are those associated with orthodontics on which a 5 percent Professional and University Orthodontics tax is applied. All medical products have to be registered and approved by the Ministry of Health. The Ministry's division of control is responsible for all registrations. With prior authorization from the MPH orthopedic prosthesis as well as other items for handicapped patients or institutions may be exonerated of tariff duties. Main Competitors Very little production occurs in Uruguay. The majority of products for local distribution are imported from Argentina Brazil Colombia the EU and the U.S. For hospital supplies major competitors for U.S. companies are suppliers from Argentina Brazil Chile Mexico China the EU and Asian countries Current Demand With the exception of low-tech monitors almost none of the medical equipment and surgical supplies sold in Uruguay is produced locally. Major market opportunities are for new technologically advanced supplies and equipment particularly in the areas of non-invasive procedures ultrasound magnetic resonance imaging and CT scans. Buyers turn to U.S. suppliers for cardio instruments and imaging as well as for blood transfusion IV and surgery equipment Global Healthcare Technologies Team Available Market Research Uruguay Medical Equipment Clinical Lab Equipment and Supplies U.S. Commercial Service Contact Information Name Lilian Amy Position Commercial Specialist Email lilian.amy #x40 N0SPAM. trade.gov Phone +011 598 2 1770 2323 Global Healthcare Technologies Team Egypt Capital Cairo Population 83+ Million GDP* $118-120 billion Currency Egyptian Pound LE Language Arabic Summary Egypt has one of the largest medical equipment markets in the Middle East mainly due to its population of over 83 million. With a lack of domestic production the market relies primarily on imports and is extremely receptive to American products. The rapidly growing population and the ongoing healthcare reform program are generating major demand for high-tech medical items. FDA approval is a key to having medical products registered and approved by the MOH in Egypt although the MOH may still do additional testing on any medical device. Red tape and non-transparency remain major business impediments in Egypt. Market Entry U.S. exporters interested in the Egyptian medical market will find it a challenging market to penetrate. The registration process in Egypt is cumbersome and complicated and has to be done by the agent of the foreign company. Egyptian commercial agents are required by law for foreign firm bids on government tenders. The agent can represent foreign companies in government tenders and will be able to handle all routine issues associated with communications bureaucratic procedures clearing goods from customs local business practices and marketing. Supplying reliable after sales service as well as spare parts and maintenance services are keys to maintaining a competitive advantage. Any imported medical device or product must be registered and approved by the Egyptian Ministry of Health. FDA approval is a key to having medical products approved although the MOH may still do additional testing on any medical device. All purchases of the MOH are done through calls for international tenders. Current Market Trends The Egyptian market is extremely receptive to American products due to the reliable high technology and associated training well-developed marketing systems and after-sale service. With the increased value of the Euro versus the U.S. dollar relative to the Egyptian pound U.S. medical companies stand a better chance of exporting their products to Egypt and increase their market share. The ongoing healthcare sector reform program and the increasing population are generating major demand for high-tech medical and healthcare products. With the government health reforms’ target of achieving universal access to healthcare by 2012 the public sector is expected to account for the majority of expenditure growth the next few years. The MOH is currently undertaking an ambitious plan of building new hospitals and medical and healthcare centers throughout the country and investing in renovating and refurbishing existing facilities with new technologies and up-to-date equipment especially in the rural under-served areas. The private sector's demand for sophisticated advanced medical equipment is also growing. Global Healthcare Technologies Team The medical equipment and supplies market in Egypt is estimated at roughly $330 million with an annual growth rate of 10% for the next five years. Despite the solid reputation U.S. market share is estimated at only 13%. Import duty is 5% plus a sales tax of 10%. Main Competitors Most competition come from European countries namely Germany UK Italy France and the Netherlands plus a number of medical equipment and supplies come from China. Current Demand With a population exceeding 83 million Egypt is the largest country in the North African region and is the U.S.’s second largest trading partner in the Arab World. The increasing population along with the ongoing healthcare modernization program is generating major demand for high quality medical devices and healthcare services. With little local production the market relies heavily on imports. Egyptian consumers’ interest in purchasing American goods is steadily rising and American companies continue to successfully compete and win major projects in Egypt. Barriers Red Tape Although the economic reformers have developed considerable momentum red tape remains a business impediment in Egypt including a multiplicity of regulations and regulatory agencies delays in clearing goods through customs arbitrary decision-making high market entry transaction costs and a generally unresponsive commercial court system. Non-Transparency Working directly with the government is time consuming and bureaucratic and the tender announcement process is not fully transparent. No foreign company can successfully cope with the cumbersome bureaucratic procedures of public procurement or the complicated registration process without a good representative in Egypt. Identifying a good well-established local agent is key to navigating the system. Import Ban The import of used and refurbished medical equipment and supplies into Egypt is banned unless there is a prior approval from the MOH. Competition U.S. suppliers will need to customize their products to meet Egyptian requirements. Competing with European products means offering cost competitive technologies that are easy to maintain and do not require replacement of expensive spare parts. Registration Paper Requirements Although the MOH accepts FDA and CE Mark certificates it will still perform additional testing and may require additional documentation. U.S. firms are advised to be willing to accommodate extensive documentation requirements to facilitate registration process by their agent. Global Healthcare Technologies Team Trade Events Name of event Mediconex Location Cairo Egypt English language website yes Description Annual exhibition for medical equipment/supplies and scientific conference held in late March showcasing the latest medical technology represented by top leading companies in the market. The conference is attended by hundreds of medical specialists and doctors and hosts some renowned professors and speakers from different specialty colleges and universities in the world. Available Market Research Market research reports are available online via our websites. Following are direct links http // export.gov/mrktresearch/index.asp http // ita.doc.gov/td/health/egyptregs.html U.S. Commercial Service Contact Information Name Rania Mekhail Position Commercial Specialist Email rania.mekhail #x40 N0SPAM. trade.gov Phone +20-2-2797-3487 Global Healthcare Technologies Team Israel Capital Jerusalem Population 7.3 million GDP Per Capita $27 300 2008 Currency Shekel Language Hebrew Summary Sales of U.S. medical instruments medical imaging equipment orthopedic appliances and surgical dressings to Israeli hospitals amounted to $164 million in 2007 Data Table 1 . A favorable Shekel-Dollar exchange rate increased the demand for U.S. made medical devices during 2008. Israel’s medical equipment market represents good opportunities for American manufacturers who already account for 35% of medical imports. Market Entry The U.S. Commercial Service in the American Embassy in Israel helps American exporters enter the market through partner search and trade promotion programs. Please visit http // BuyUSA.gov/israel or contact yael.torres #x40 N0SPAM. trade.gov . Licensing of imported and locally manufactured medical devices and equipment is subject to enforcement according to a Ministry of Health directive which went into effect on January 1 1995. Companies interested in exporting medical equipment or devices to Israel should first appoint a local representative who will apply for a device registration from the Ministry of Health. The request should be accompanied by one of the following documents - 510 k - Pre-Market Approval PMA or - Investigational Device Exemption IDE Because the Ministry of Health uses the FDA’s standards and ECRI nomenclature for the purpose of issuing licenses the licensing procedures for American-made medical equipment are fairly easily facilitated. Implantable medical devices require mandatory labeling in the patient’s file for tracking and surveillance purposes. The labels must contain the following information - Name and address of the manufacturer - Name and address of the importer - Type of implant - Sub-type of implant -Size - Serial number - Batch number Global Healthcare Technologies Team Current Market Trends Technology amp Research Cooperation Israeli medical companies are ranked third worldwide in the number of granted patents per capita rendering the medical sector highly active and innovative. Opportunities for U.S. companies exist in the area of research clinical trials and academic and professional exchanges. Israel’s medical device companies develop implantable and disposable therapeutic devices for cardiovascular and peripheral vascular disease oncology neurodegenerative diseases and other age-related diseases such as ophthalmic and orthopedic indications. Other developed industry areas include diagnostic imaging and monitoring devices. A smaller number of companies focus on endocrinology wound management and respiratory disease. Source Israel Life Science Industry Main Competitors Israel is a sophisticated and mature market. U.S. suppliers face intense European competition. U.S. companies should be ready to compete. Current Demand Israeli hospitals are well-equipped but overburdened and much of the equipment needs to be updated. While there is no government plan in place for a massive investment in new devices in 2009 hospitals are likely to replace equipment on an ad-hoc basis and to keep up with the latest most advanced technologies. To generate extra income Israeli hospitals provide private care in addition to public healthcare services. A well-developed private sector dominates the areas of dental care eye laser surgery and plastic/aesthetic surgery. Medical tourism is also a growing niche service that helps generate additional income from the private sector. Both private healthcare and medical tourism are likely to prompt the need and provide the funds for upgrading existing systems and purchasing new equipment. This represents a good export potential for U.S. manufacturers of advanced medical technologies instruments and disposables in the following categories Imaging instruments cardiology equipment equipment and supplies for plastic surgery dental instruments equipment and technologies for pain management and physiotherapy ozone amp oxygen therapy OR equipment and single use products point of care diagnostic kits wound management technologies. In 2008 the Israeli government issued a preliminary tender for the construction and management of a brand new 300-bed general hospital in the city of Ashdod. The tender is likely to enter a final stage during 2009. Barriers Nearly all tariffs on trade between the U.S. and Israel have been eliminated since 1995. Because the Israel Ministry of Health uses the FDA’s standards for the purpose of issuing licenses the licensing procedures for American-made USFDA approved medical equipment are fairly easily facilitated. Global Healthcare Technologies Team Trade Events The Medical Trade show in Dusseldorf Germany is the most visited medical professional trade show by Israeli importers and end-users. The annual BioMed event in Israel highlights innovation and achievements of the Israeli life science industry. U.S. companies are welcome to explore strategic alliances and investment opportunities during the BioMed week in Israel held every in June in Tel Aviv. For additional information please email to yael.torres #x40 N0SPAM. trade.gov Available Market Research CS Tel Aviv provides customized market research and company status profiles. To request a quote please contact yael.torres #x40 N0SPAM. trade.gov U.S. Commercial Service Contact Information Name Yael Torres Position Commercial Specialist Email yael.torres #x40 N0SPAM. trade.gov Phone 972-3-519-7611 Global Healthcare Technologies Team Morocco Capital Rabat Population 33 757 175 2007 estimate GDP* $152.5 billion 2006 estimate Currency Moroccan Dirham MAD Language Arabic official language French business language English Summary Morocco is a promising market for medical equipment offering exceptionally good sales opportunities for U.S. exporters. The reforms introducing mandatory healthcare coverage the increase in the Government expenditure and increase in number of public and private hospitals have strengthened the performance of this sector. During the recent years Morocco has been a leading country in the African region in terms of healthcare equipment and services and serves as a healthcare center for neighboring Sub-Saharan countries. Market Entry To meet the population growth rate 1.4% and the growing domestic demand for modern and western healthcare standards the Ministry of Health continues to modernize the healthcare system. The Government’s 2008-2012 Action Plan budget allocated approximately USD 6.6 billion equivalent to 57.3 billion Moroccan Dirhams to healthcare this was 31.8% increased compared to the 2003-2007 Action Plan. To increase hospital in-patient capacity improve hospital operations and automate the systems the Ministry of Health plans to build by 2012 new regional hospitals university hospitals epidemiology laboratories blood centers and to upgrade 120 existing hospitals with modern equipment. Current Market Trends Suppliers of medical and laboratory equipment should consider entering this market. All medical equipment and devices should obtain a registration with the Ministry of Health before entering the market. Used equipment is not allowed in the Government hospitals but can find excellent opportunities in the private sector. U.S. companies interested in selling in Morocco are advised to find a local partner to act as the sole distributor/agent. In addition the USA-Morocco Free Trade Agreement offers “competitive import advantage” over foreign competitors. Main Competitors Local medical material and equipment production is extremely low 10% and limited to technologically basic materials. It is mainly centered on furniture which does not comply with international standards and single use material such as bandages and syringes. Morocco relies on imports to supply hospital facilities with technologically advanced medical devices such as Ultra-Sonic scanning Magnetic resonance imaging X-Rays Electro-diagnostic equipment Computerized tomography Monitoring equipment E-medicine equipment and related software. Global Healthcare Technologies Team Trade Events Medical Expo Office des Foires de Casablanca Casablanca Fair Grounds Casablanca Morocco January 2011 Available Market Research Ministry of Public Health http // sante.gov.ma U.S. Commercial Service Contact Information Name Najia Tourougui Position Commercial Specialist Email najia.tourougui #x40 N0SPAM. trade.gov Phone 212 522 264 550 Ext. 4180 Global Healthcare Technologies Team South Africa Capital Pretoria Population 47.84 million 2008 estimate GDP* $283.5 billion Currency South African Rand Languages English- business language 10 other official languages- Afrikaans Ndebele Pedi Sotho Swati Tsonga Tswana Venda Xhosa Zulu Summary Healthcare sector spending amounts to $23.4 billion 8.6 percent of GDP more or less divided equally between the private and public health sector. However the private sector caters to approximately 20 percent of the population who enjoy world class facilities and medical aid coverage with the remainder receiving basic primary services provided by public healthcare. The structure of healthcare provision is almost exclusively concerned with primary hospital care in the public sector. It is in the incoming administration’s plans to develop rural clinics and improve public hospitals which will unlock demand for Western technologies and medicine. Bio-medical medical devices and equipment have great potential in South Africa as local manufacturer is concentrated on low-tech and low value devices such as surgical goods and disposables. Market Entry The best way to enter the South African market is to find a local distributor or agent. A distributor will normally be well experienced in the industry with a nationwide presence and have a good back-up technical service workshop. Electronic medical devices are the only medical devices that are regulated policy is currently being drafted to regulate all segments of the sector. Likewise rules make no distinction between used and new equipment. Almost all medical device imports are exempt from customs tariffs to facilitate supply of high-tech devices that cannot be manufactured locally. Current Market Trends The total market size of medical devices in South Africa is estimated to be $860 million 3.7 percent of total healthcare market with 90 percent attributable to imports primarily from the United States the European Union and Japan. Imports are expected to increase steadily for the next three years. Global Healthcare Technologies Team Main Competitors Main Competitors Most multi-national brands are represented in South Africa. New inventions or cheaper versions of current technology generally perform well. Current Demand Demand for health products and devices especially in the areas of wound management are expected to grow over the next few years. Acute wounds are a major problem due to the high level of violent crime and diabetes. Barriers Regulation and reimbursement failings complicate access. In terms of reimbursement medical devices for public healthcare sector procurement are biased towards local manufacturers. Many public institutions also operate a system of ‘preferred suppliers’ whereby they will only source from companies on their preferred supplier list. For this reason most multinationals have local offices or operate through distributors in order to facilitate market access. Global Healthcare Technologies Team Trade Events Name of event Pan African Health Conference amp Expo Location Midrand Johannesburg English language website http // fairconsultants Description Event running from September 17 - 19 2009. The main objective of this event is to promote the medical industry including medical technology and pharmaceutics throughout Africa. This Exhibition and Conference is Africa's only dedicated fully representative event for trade promotion opportunities in the medical amp healthcare sectors in Africa. Name of event Biotech Africa Location Sandton Johannesburg English language website http // biztradeshows /trade-events/biotech-africa.html Description Event running from August 09-21 2009. Biotech Africa aims to bring together all players of the biotech industry under one roof provide ideal environs for sharing of technologies ideas and experiences and prepare a blueprint for the future. Available Market Research Electro-Medical Device Market Overview and Regulations May 2009 U.S. Commercial Service Contact Information Name Nolubabalo Ndevu Position Commercial Specialist Email Nolubabalo.ndevu #x40 N0SPAM. mail.doc.gov Phone +27 21 7027345 Global Healthcare Technologies Team Australia Capital Canberra Population 21.5 million GDP* $799 billion Currency Australian Dollar Language English Summary The Australian medical equipment industry sector has consistently provided good prospects for U.S. exporters. Australia is the ninth largest market for U.S. exporters of medical products. Approximately 90 percent of medical devices and diagnostics used in the market are imports. The three major suppliers are the United States the European Union and Japan. U.S. medical equipment is traditionally well-received due to its perceived high-quality. The market is sophisticated mature and quick to adopt new healthcare technologies. Importers seek to obtain cost-effective and innovative products that will improve patient outcomes and reduce healthcare costs. Market Entry The Therapeutic Goods Administration TGA regulates Australia’s medical equipment industry. Australia’s regulatory framework is based on Global Harmonization Task Force GHTF and European Community guidelines. U.S. exporters must appoint an Australian representative/sponsor to obtain regulatory approval from the TGA. U.S.-manufactured medical devices require an EC Certificate from a European Union Notified Body. Alternatively U.S. manufacturers can apply to the TGA for a Conformity Assessment Certificate. Information on Australia’s regulatory requirements can be obtained from the TGA’s website tga.gov.au Current Market Trends Australia has a high per capita income and there is demand for a full range of medical equipment. The $4 billion market is price sensitive and competitive. Australia spends approximately 9 percent of its GDP on healthcare which is more than the United Kingdom 8.3 percent similar to Italy 8.9 percent and less than the United States 15.3 percent . Australia’s ageing population will significantly influence the demand for products and products that serve the ageing population are likely to experience growth. The growth of chronic disease in Australia is similar to that in other developed nations. Australians increasingly suffer from asthma cancer diabetes heart stroke and vascular disease osteoarthritis rheumatoid arthritis and osteoporosis. Opportunities exist for technologies that avert or reduce disability as a result of these diseases. Other opportunities exist for diagnostic ophthalmologic orthopedic and wound care products as well as products that address obesity. Diseases and illnesses for which incidence and prevalence rates are projected to increase include diabetes stroke coronary heart disease lung cancer and musculoskeletal disorders. Global Healthcare Technologies Team Main Competitors Imports supply approximately 90 percent of Australia’s demand for medical equipment. Key suppliers include the United States the European Union Switzerland and Japan. Many suppliers in the Australian industry are subsidiaries of overseas corporations. The major American medical companies represented in Australia either through local representatives or subsidiary offices include Bard Baxter Healthcare Boston Scientific Cook Medical Johnson amp Johnson Medical Medtronic St. Jude Medical and Stryker. U.S. companies may experience strong competition from American firms or multinationals already in the market. Current Demand Australia’s high standard of medical practice and ageing population underpin a continued demand for a range of sophisticated high quality and innovative medical equipment. Importers seek to source cost-effective and innovative products that will improve patient outcomes and reduce healthcare costs. Opportunities exist for products that provide a significant improvement in clinical outcomes and products with clearly differentiated capabilities. There is also a growing demand for products that lead to faster patient recovery reduce hospital and rehabilitation costs and alleviate or manage disability and chronic pain. Government healthcare policies and public health influence the volume and pricing of healthcare products and services. Both the public and private sectors provide healthcare in Australia. Federal and State government spending accounts for 70 percent of total healthcare expenditure. The nongovernmental sector individuals and private health insurance funds the remaining 30 percent. Approximately 45 percent of Australians have private health insurance. Trade Events MEDICAL FAIR AUSTRALIA 2010 Date 4-6 May 2010 Location Sydney Convention and Exhibition Centre Website http // hospimedica-australia /event.html This bi-annual exhibition showcases hospital diagnostic pharmaceutical medical and rehabilitation equipment and supplies. Available Market Research Australia Aged Care Sector March 2009 Australia Analytical and Clinical Chemistry April 2008 Australia Medical Equipment April 2008 Australia Hospitals February 2008 U.S. Commercial Service Contact Information Name Monique Roos Position Commercial Specialist Email monique.roos #x40 N0SPAM. trade.gov Phone +61 2 9373 9210 Global Healthcare Technologies Team People's Republic of China Capital Beijing Population 1 338 612 968 July 2009 est GDP* $4.222 trillion 2008 est. Currency Reminbi RMB Language Mandarin Chinese Summary China is now the world’s third largest market for medical equipment. China’s healthcare market is severely underdeveloped and offers significant potential for U.S. companies interested in expanding into the Chinese market. The Chinese government has mandated $124 billion to develop basic healthcare infrastructure in hopes of providing every Chinese national the basic healthcare coverage they deserve. Chinese healthcare companies provide low-end technology and generally lack the expertise and experience deemed appropriate by Western standards. The Chinese also view foreign healthcare companies as more credible than their Chinese counterparts. The Chinese healthcare market is poised to be explored by those foreign enterprises interested. Market Entry 2006 Share 2007 Share 2008 Share World 4 831 5 657 7 196 US 1 648 34% 2 022 35% 2 504 34% Germany 837 17% 1 033 18% 1 303 18% Japan 828 17% 884 15% 1 151 15% Current Market Trends According to information from the China Association for Medical Devices Industry CAMDI China’s medical equipment market grows at 15% annually with a total size of $10.2 billion in 2008 and the figure is expected to reach as high as $17.5 billion by 2010. An annual growth of sales of large high-end medical equipment was reported between 20-30%. Clinical laboratory equipment and reagent sales are growing at about 15 to 20% per annum. According to incomplete figures from the World Trade Atlas China’s imports of medical equipment accounted for about $5.7 billion in 2007 and $7.2 billion in 2008 showing an increase of over 27%. Main Competitors Depending on the specific type of products foreign competitors are typically from the European Union or Japan as their respective markets for healthcare are structured and well developed. Global Healthcare Technologies Team Current Demand Chinese end users consider U.S. products to be of superior quality and the most technologically advanced. China’s hospitals particularly welcome medical equipment and products with high-technology content. At the same time domestic medical device companies are consolidating upgrading quality and beginning to compete in medium-level technology niches. Released in late 2008 China’s healthcare system reform scheme is expected to have a significant impact on the market outlook in China. It is intending to provide basic healthcare access and coverage for the entire population of China. The government has guaranteed to designate $124 billion between 2009 and 2011. This scheme is directed to the development of basic healthcare infrastructure. Barriers Barriers exist with an uncertain regulatory environment and extensive delays in registration and reregistration of products although efforts are reportedly being made to reduce the large backlog. Pricing tenders and bar code systems also play a role in delaying companies’ entry into the Chinese medical device market. Trade Events SINO-Dental 2009 June 10-13 2009 Location Beijing-China International Exhibition Center Website chinamed.net.cn/en/Default.asp Started in 1995 SINO-Dental is the largest dental exhibition in China. Its popularity continues to grow as the 28 000 sq meter facility drew 540 exhibitors from 18 countries for 62 800+ visitors from 75 countries in 2008 alone. MEDTEC China September 8-10 2009 Location Shanghai-Intex Website http // devicelink /expo/shanghai09/index_en.html The 5th annual MEDTEC China Exhibition and Conference will allow manufacturers to have access to the latest technologies techniques and equipment. Experts now attend MEDTEC China on an annual basis to view learn and meet suppliers as well as attend seminars. Care amp Rehabilitation Expo China 2009 September 10-12 Location Beijing-China International Exhibition Center Over 150 000 visitors are expected to attend mainly from the Central People’s Government and local government officials. Doctors nurses volunteers rehabilitation employees manufacturers distributors and the general public will be in attendance. Website http // crexpo .cn/english/ Global Healthcare Technologies Team Available Market Research China Clinical Laboratory Market http // buyusainfo.net/docs/x_5325735.pdf China Ophthalmic Equipment and Products Market http // buyusainfo.net/info.cfm id=14265329 amp keyx=A2290215CB1509A59081A430A99C8D84 amp dbf = mrsearch1 amp loadnav= amp archived=no amp addid= China Gynecological Devices and Products http // buyusainfo.net/docs/x_3244830.pdf Pre-hospital Emergency Medical Service and Equipment in China http // buyusainfo.net/docs/x_918621.pdf Measures for the Administration of Medical Device Registration English Translation http // buyusainfo.net/docs/x_525872.pdf U.S. Commercial Service Contact Information Beijing Shuyu Sun Senior Commercial Specialist Email shuyu.sun #x40 N0SPAM. trade.gov Tel 8610-8531-3946 Shanghai Lynn Jiao Senior Commercial Specialist Email lynn.jiao #x40 N0SPAM. trade.gov Tel 8621-6279-8750 Guangzhou Shuquan Sherman Li Senior Commercial Specialist Email shuquan.li #x40 N0SPAM. trade.gov Tel 8620-8667-4011 ext. 625 Chengdu Misha Cao Commercial Representative Email xiao.cao #x40 N0SPAM. mail.doc.gov Tell 028-8558-3992 ext. 6939 Global Healthcare Technologies Team India Capital New Delhi Population 1.17 billion GDP* $3.319 trillion PPP Currency Indian National Rupee INR Language Hindi English Summary The Indian healthcare industry is experiencing a rapid transformation. According to a World Health Report India spends about 5.2 percent of its GDP on the healthcare sector which is expected to rise to 6.1 percent of GDP by 2012. The World Health Organization forecasts that India needs at least 80 000 hospital beds per year for the next five years to meet the expanding local demand. The Indian healthcare industry is estimated at $35 billion and is expected to reach over $75 billion by 2012. The medical equipment market is growing at an impressive rate of 15 percent. The hospital facilities depend on the import of high-end medical equipment. Market Entry In India healthcare is delivered through both the public and private sectors. The private sector’s contribution to healthcare has been growing at a faster pace than the government’s. There are no restrictions on foreign direct investment in healthcare services. Import of medical equipment is allowed under the “Open General” category of the Import regulations except for nuclear medicine. Customs duty levied on imported products depends on the product classification for some devices the duty has been brought down from 25 to 7 percent. Products classified as “life saving equipment” have reduced duty applicable on them. Price quality and after-sales service support are major factors in medical equipment purchase decisions. Letters of credit are usually the mode of payment for imports. Purchasing decisions in government follow a tendering process and is time consuming while the process is faster in private hospitals. Current Market Trends Indian population of 1 billion people is growing at a rate of 2.5 percent per year. Of that total about 200300 million people have both the demand for and the discretionary income to purchase private health care services. This trend is likely to continue for the next several years sustaining the growth of hospital facilities. The changed demographic profile and the rise of lifestyle-related diseases has altered the health-seeking behavior of the consumer. The number of lives covered by health plans has increased but there is a large Indian population that still needs to be insured. Both the government and private sector are planning new hospitals as well as improvements to existing hospitals. Companies are sensing the huge untapped opportunity in delivery of quality healthcare to the Indian masses and focusing on tertiary-level preventive and diagnostic healthcare. The public sector is engaged in the prevention and elimination of infectious diseases and the accessibility of basic healthcare facilities to the rural masses. The National Rural Health Mission 2005-2020 aims to provide medical care to the all rural Indians. Not only providers but also global private equity and venture capital funds are vying to explore opportunities. The demand for medical equipment is expected to reach $5 billion by 2012 from current figure of $2.7 billion. Imports account for over 65 percent of the entire medical equipment market of which 85% is from the United States. Global Healthcare Technologies Team India treated 450 000 foreign patients in 2007. Medical travel is one of the major external drivers of growth. With increased competition for healthcare delivery “Quality healthcare is the key for survival.” Some private hospitals are applying for accreditation from international bodies. Main Competitors The large private healthcare services providers are actively seeking growth by enhancing their reach across the country through the building new hospitals and acquiring and upgrading existing hospitals. There are several groups operating hospital chains including Apollo Group Fortis Healthcare Manipal Group Max Healthcare and Wockhardt Hospitals. In the medical equipment segment competition is from the imports from European companies and Japan. There is also competition from low priced Chinese products as India is a price-sensitive market. Current Demand The growing demand for quality healthcare and the absence of matching delivery mechanisms pose both challenges and opportunities. In infrastructure – building equipping managing and financing of hospitals are areas for growth. Some best sales prospects in the medical equipment market include cancer diagnostic cardiac products medical imaging plastic surgery equipment and orthopedic appliances. Barriers To ensure the quality of healthcare service the Indian Government is in the process of developing regulations for medical devices. The authority regulating medical devices Central Drug Standard Control Organization has listed devices for regulation http // cdsco.nic.in . The unclear guidelines/procedures are sometimes a problem when importing medical devices. There are ongoing efforts to resolve the issues through industry and government to government dialogues. The Indian government has identified healthcare as a priority sector. Trade Events Name of event IDEM Indian 2009 International Dental Exhibition Location Mumbai English language website http // idem-india Description In October 2009 the exhibition and workshops will highlight dental technology and dentistry. Name of event Medical Trade Mission to India Location Delhi Chennai Mumbai English language website http // buyusa.gov/india/en/296.html Description Trade mission in March 2010 will visit three cities to learn about the market and establishing associations through one-on-one meetings. Companies will also have an option to participate in the U.S. pavilion at the Medical Fair India 2010. Available Market Research India Dental Equipment Market May 2009 http //buyusainfo.net/docs/x_5821243.pdf Global Healthcare Technologies Team U.S. Commercial Service Contact Information Name Srimoti Mukherji Position Senior Commercial Specialist Email srimoti.mukherji #x40 N0SPAM. trade.gov Phone 91-11-2347 2226 Global Healthcare Technologies Team Indonesia Capital Jakarta Population 237 million 2008 est. GDP* $511 billion 2008 est. Currency Rupiah Language Indonesian Summary Indonesia offers a large potential for the medical equipment and supplies market with an annual growth of 15 to 20 percent. The market will continue to grow in the coming years as over 85% of medical equipment and supplies are imported. Indonesia’s large population of 237 million people makes it one of the world’s largest markets for medical equipment and healthcare services. U.S. manufacturers of medical devices should take advantage of this growing market. Market Entry U.S. companies must appoint Indonesian agents/distributors to market medical equipment and supplies in Indonesia. Local agents/distributors play an important role in developing the market and providing after- sales services. Current Market Trends Indonesians spend over $1 billion annually for quality healthcare overseas mostly in Singapore Malaysia Thailand and a few other countries. In a bid to stem the flow of patients seeking medical treatment abroad the Indonesian government continues to urge hospitals to improve their services to compete with world-class hospitals abroad. Indonesia has 1 292 hospitals and 8 234 health centers. These hospitals and health centers provide health services to more than 237 million people spread over the 33 provinces of Indonesia. Central and regional governments continue to upgrade their facilities in order to provide basic healthcare services. Main Competitors The market for medical equipment and supplies is highly competitive. The U.S. is the largest importer of medical equipment to Indonesia accounting for 15 percent. Currently third-country producers of medical equipment competing with the U.S. include Germany China Japan Singapore France and the United Kingdom. Current Demand Best Prospects • Diagnostics and laboratory reagents • Electro diagnostic equipment and x-ray unit • Disposable syringes • Life support equipment such as ventilators anesthesia and respiratory equipment Global Healthcare Technologies Team Barriers There are no restrictions on the importation of medical equipment. The equipment is subject to a 0-5 percent import tax and value added tax of 10 percent. The Ministry of Health controls the registration of medical equipment in Indonesia. In general products that are FDA-approved and sold in the U.S. will be approved to enter the market in Indonesia. Trade Events Name of Event Hospital Expo 2009 Location Jakarta Website http // hospital-expo / Description An annual event organized by the Indonesian Hospitals Association PERSI . Over 200 companies participated in the 2008 expo. Foreign exhibitors included companies from Pakistan China Korea and Malaysia. European and American companies were represented by their distributors. Available Market Research Dental Equipment and Supplies April 2009 http //buyusainfo.net/docs/x_9646856.pdf Medical Equipment and Supplies May 2009 http //buyusainfo.net/docs/x_2399064.pdf Clinical Laboratory Equipment June 2008 http //buyusainfo.net/docs/x_9935089.pdf 2005-2010 Import Tariffs February 2005 http //buyusainfo.net/info.cfm id=129820 amp keyx=FB6817E1F2E6C184565FB4E2017F9A0D amp dbf=mrsearc h1 amp loadnav= amp archived=no amp addid= U.S. Commercial Service Contact Information Name Sharon Chandra Position Commercial Specialist Email sharon.chandra #x40 N0SPAM. trade.gov Phone 62-21 5262850 Global Healthcare Technologies Team Japan Capital Tokyo Population 127 288 419 2009 estimate GDP* roughly $5 trillion 2008 Currency Yen Language Japanese Summary Japan continues to be one of the most important destination for U.S. medical device and pharmaceutical companies. The Japanese market for medical equipment is one of the few sectors where the United States has consistently enjoyed a sizeable trade surplus with Japan. In 2007 the Japanese market for medical devices and materials was just over USD18 billion. Total imports were estimated to be approximately 50 percent of the market. U.S. products represented around a 56 percent share of the import market and accounted for approximately 27 percent of Japan's total medical equipment market valued at approximately $5 billion. As for pharmaceuticals in 2007 the Japanese market for pharmaceuticals was approximately $68 billion. The market share for foreign firms is estimated to be approximately 40 percent if one includes direct imports local production by foreign firms and compounds licensed to Japanese manufacturers. American pharmaceutical firms have achieved a market share of approximately 20 percent. Market Entry A Japanese company that intends to market a foreign medical device needs to obtain a "license for manufacturing/marketing business" seizo hanbai gyo kyoka . The company holding this license is called a "Marketing Authorization Holder MAH ." An MAH must be physically located in Japan. The MAH must obtain marketing approval for each product. Typically a marketing approval application is submitted under the name of the MAH which will give the MAH complete control of the approved product in Japan. If a foreign company would like to obtain a marketing approval under its own name the foreign firm can designate an MAH when applying for a marketing approval. This Designated MAH D-MAH can be an importer/distributor and/or a neutral third party such as a healthcare consulting company . Typically as a first step a foreign manufacturer that lacks a Japanese subsidiary will sell their products through an importer/distributor an MAH in Japan. Then after establishing their market position the foreign company can choose to continue working with their existing importer/distributor or establish their own Japanese office. A foreign company without an office in Japan cannot directly apply for marketing approval. Therefore unless a foreign company plans to open an office in Japan it is extremely important that the company work with an importer/distributor in Japan who is interested in a long-term relationship. Market Entry Options for U.S. Manufacturers If a U.S. firm has a subsidiary in Japan that subsidiary can become an MAH and obtain marketing approval hanbai shonin for each product. If a U.S. firm does not have a subsidiary in Japan there are three options for conducting business in Japan 1 The U.S. firm can ask their importer/distributor to obtain the hanbai shonin in the name of the importer/distributor. In this case the importer/distributor will have complete control over the U.S. firm’s products when marketing in Japan. 2 The U.S. firm can obtain the hanbai shonin in its own name by designating their importer/distributor as a D-MAH. 3 The U.S. firm can obtain the hanbai shonin in their own name through a neutral third party formally known as an “In-Country Caretaker” by designating them as a D-MAH. Global Healthcare Technologies Team For new-to-market foreign pharmaceutical companies the best way to enter the Japanese market is to work with a Japan-based company through an agent distributor or licensing agreement. It is very difficult for a foreign company to establish their own sales channels in Japan since the market is full of both local and foreign affiliated companies with existing sales channels. Current Market Trends While the market for U.S. medical equipment in Japan remains strong the revision of the Pharmaceutical Affairs Law PAL in April 2005 and the Government of Japan’s efforts to contain overall healthcare costs due to its aging society have created a challenging environment for U.S. firms. The Government of Japan however is proposing various measures to enhance the competitiveness of its medical device and pharmaceutical industry. The country also aims to supply innovative pharmaceuticals and medical devices to Japanese patients in a timelier manner. For example in December 2008 Japan issued the “Action Programs for Speedy Review of Medical Devices” that included specific actions and goals to expedite product approval processes such as increasing the number of reviewers from 35 to 104 and completing standard reviews in 14 months and priority reviews in 10 months by April 2014 among other items. With regard to pharmaceuticals in 2007 Japan set goals to reduce the period from drug development to approval by two and a half years by 2011 improve the regulatory system by more than doubling the staff of drug reviewers by 2010 promote drug clinical trials and stimulate the development of vaccines. Japan has also shown strong interest in fostering simultaneous global drug development. These measures are expected to improve and speed up Japan’s regulatory approvals system and should benefit U.S. medical device and pharmaceutical companies that can offer innovative products to Japanese patients. General Japanese Medical Indicators Population July 2008 est. 1 127 288 419 Age Structure 2008 est. 1 0-14 years 13.7% 15-64 years 64.7% 65 years and over 21.6% Birth Rate 2008 est. 1 7.87 births/1 000 population Death Rate 2008 est. 1 9.26 deaths/1 000 population Population Growth 2008 est. 1 - 0.139% Infant Mortality Rate 2008 est. 1 0.28% Fertility Rate 2008 est. 1 1.22 children born/woman Life Expectancy 2008 est. 1 Total Population 78.73 Female 85.59 Male 78.73 Healthcare Expenditure 2007 2 USD 283.1 billion JPY33.4 trillion Healthcare Expenditure as % of GDP 2006 3 8.2% Number of Hospitals 2006 2 8 943 Number of Hospital Beds 2006 2 1 786 649 Average Hospital Stay 2006 2 34.7 days Number of General Clinics 2006 2 97 442 Number of Dental Clinics 2006 2 67 392 Sources The World Fact Book Central Intelligence Agency CIA 2008 Ministry of Health Labour and Welfare MHLW OECD Health Date 2008 Organization for Economic Co-operation and Development OECD . Global Healthcare Technologies Team Main Competitors According to the 2007 Survey of the Pharmaceutical and Medical Device Industry of Japan by MHLW in 2005 1 543 companies including both Japanese and foreign affiliated companies obtained authorization for manufacturing and/or marketing of medical devices in Japan. Approximately 60 percent of the companies were relatively small with fewer than 49 employees. Large companies with more than 300 employees accounted for only 1.9 percent of the total. Leading Japanese medical device manufacturers include Terumo Aloka Toshiba Medical Nihon Koden Olympus Hitachi Medical Shimadzu etc. As is the case for pharmaceutical companies many leading foreign medical device companies operate in Japan such as Medtronic U.S. Johnson amp Johnson U.S. Boston Scientific U.S. Baxter U.S. GE Medical Systems U.S. Stryker U.S. Edward Lifesciences U.S. Smith amp Nephew U.K. etc. With regard to pharmaceuticals in 2005 1 660 companies including both Japanese and foreign affiliated companies obtained authorization for manufacturing and/or marketing of pharmaceutical products in Japan. The top 30 companies accounted for 74.9 percent of total pharmaceutical sales and for 79.6 percent of total prescription pharmaceutical sales. The Japanese pharmaceutical company market share was projected to be approximately 60 percent. In terms of pharmaceuticals with new active ingredients however the percentage of foreign made products was estimated to be around 75 percent. Leading Japanese pharmaceutical companies include Takeda Astellas Daiichi Sankyo Eisai Otsuka etc. Almost all of the leading foreign pharmaceutical companies operate in Japan including Pfizer U.S. Janssen U.S. Merck U.S. Eli Lilly U.S. Wyeth U.S. Novartis Swiss Glaxo Smith Kline U.K. etc. Current Demand Due to an increasing number of patients with chronic lifestyle diseases such as diabetes medical devices to treat age related diseases should show steady growth in demand. Devices that show promising growth prospects include equipment to assist biofunctions such as pacemakers cardiac valve prostheses and orthopedic implants. Other areas of projected strong demand include advanced diagnostic imaging equipment such as high-end MRI CT/PET PET and digital radiography. Favorable changes in the reimbursement system and political climate may spur new growth in advanced diagnostic imaging technologies. New leading edge medical devices will also have good market prospects. The top selling pharmaceuticals in Japan are for cardiovascular diseases 17 percent share of the market and demand for the drugs is increasing due to Japan’s aging society. Other drugs with increasing demand include diabetic drugs anticancer drugs etc. In the New Pharmaceutical Industry Vision MHLW cited anti-cancer drugs as one area that will have good growth prospects in the years ahead. Vaccines are another area with good growth potential. The Japanese government will also further promote the use of generic drugs to ease the cost burden on the healthcare system. Global Healthcare Technologies Team Barriers One of the major market access obstacles is Japan’s regulatory approvals process which is heavily regulated under the Pharmaceutical Affairs Law PAL and is often described as the slowest in the industrialized world. This is especially true for medical devices. The Japanese government has recognized that the country suffers from a drug and medical device “lag” whereby innovative drugs and medical devices are frequently introduced elsewhere in the world years before they are available in Japan. The other major obstacle is Japan’s reimbursement policies which aim to curb healthcare spending. The rapid aging of Japan's population makes it difficult for Japan to control growth of the nation's medical expenditures. The national health insurance system’s shinryo-hoshu medical fees are typically revised biannually. Medical service fees include both drug and medical device reimbursement prices in addition to doctor's fees fees for diagnosis treatment and other services provided by doctors . Japan has been taking financial measures to make up for immediate budget short falls rather than correcting inefficiencies in Japan’s healthcare system. Those measures include 1 cutting prices of medical devices and drugs through price revisions 2 raising the co-payment for both salaried workers and the elderly and 3 implementing price rules that drive down prices of medical devices and drugs. Trade Events Name of event International Technical Exhibition of Medical Imaging ITEM Location Yokohama English language website http // jira-net.or.jp/e/event/event_006.html Description ITEM is a comprehensive academic exhibition in Japan for the latest medical imaging systems and peripheral devices. Name of event International Modern Hospital Show IMHS Location Tokyo English language website http // noma.or.jp/english/index.html Description IMHS is one of the major Japanese trade shows in Japan for healthcare products with 380 companies and 78 000 visitors. Name of event INTERPHEX Japan Location Tokyo English language website http // interphex.jp/ipj/english/index.phtml Description INTERPHEX JAPAN is the ASIA'S LARGEST pharmaceutical industry event with 1 400 exhibitors and 63 000 visitors. Name of event HOSPEX Japan International Hospital Engineering Location Tokyo English language website http // jma.or.jp/indexeng.html Description HOSPEX Japan is one of the major trade shows for hospital facility products health and medical treatment information systems etc. with 200 companies and 35 000 visitors. Global Healthcare Technologies Team Available Market Research le Market Research Japan External Trade Organization JETRO – Market Information http // jetro.go.jp/en/reports/market/ Japan Pharmaceutical Manufacturers Association JPMA -“Pharmaceutical Administration and Regulations in Japan” http // jpma.or.jp/english/parj/0803.html U.S. International Trade Commission – “Medical Devices and Equipment Conditions Affecting U.S. Trade in Japan and Other Principal Foreign Markets” Available at a fee http // ntis.gov/search/product.aspx ABBR=PB2009113427 There are a number of technical exhibitions held in conjunction with annual meetings of each specialized medical society. A list of Japanese medical societies is available at http // umin.ac.jp/ac/english.htm although the organizations’ home pages are in Japanese and some require membership. U.S. Commercial Service Contact Information Name Hiroyuki Hanawa Position Commercial Specialist Email hiroyuki.hanawa #x40 N0SPAM. trade.gov Phone +81-3-3224-5083 Global Healthcare Technologies Team Korea South Capital Seoul Population 48 508 972 2008 estimate GDP* 1.278 trillion 2008 estimate Currency Won Language Korean Summary Korea is one of the largest Asian markets for medical devices. The market was valued at $3 billion in 2006 and is expected to have increased to approximately $3.4 billion in 2007. The medical device market is forecasted to grow at an average annual rate of 10-15 percent over the next few years. Market Entry Distribution/Business Practices/Key Competitive factors Medical devices are distributed through local distributors mostly. A local distributor may directly cover the whole country on an exclusive basis. Or the master distributor may contract with other regional sub- dealers. Major international suppliers work directly on advertising make direct contact with doctors and provide them with technical assistance. However actual sales are made through Korean distributors. As Korea is a geographically small country one reliable distributor to cover the country on an exclusive basis is highly recommended for the Korean market. Working with a faithful local firm on a long-term basis is a key to success. Current Market Trends Market demand for advanced and innovative medical devices is expected to remain strong in 2009 and over the next several years as Korea’s hospitals continue to purchase advanced technology products from abroad and as increasing numbers of elderly Korean patients require sophisticated medical procedures. Currently best prospective medical device products in Korea include stents MRI systems CT scan systems dialysis machines orthopedic implants particularly knee prosthesis ophthalmic lenses dental implant soft contact lenses surgical lasers etc. Main Competitors Korea depends on advanced medical devices from the U.S. EU and Japan to supply about 60 percent of total market demand. Current Demand In 2008 total imports of medical devices were estimated at $2.3 billion with U.S. imports estimated to be $819 million representing a 34 percent import market share. Market demand for advanced and innovative medical devices in 2008 was estimated to grow slowly due to the recent high exchange rate of the Korean Won vis-à-vis the U.S. dollar and Japanese Yen resulted from current economic downturn Global Healthcare Technologies Team Barriers Pre-market License All medical device products are required to obtain marketing clearance from the Korea Food amp Drug Administration KFDA before they are manufactured in or imported into Korea. Currently medical devices are classified into four categories in Korea depending upon technical attributes and product use. KFDA requires pre-market notification for class I devices and pre-market approval for class II III and IV devices. Class III and IV devices must pass the most stringent technical review by a KFDA with authorized labs to prove their safety and effectiveness. Since KFDA issues product licenses only to locally based firms all foreign suppliers must submit required documentation and receive necessary approvals through their Korean importers or U.S. supplier’s corporation located in Korea. National Health Insurance Program amp Reimbursement pricing One important factor which may slow the rate of growth in market demand for medical devices over the next few years is recent medical insurance reimbursement price MIRP cuts for medical devices and planned new pricing system on medical devices. Trade Events Name of event Korean International Medical amp Hospital Equipments Show KIMES 2010 Location Seoul Website kimes.kr KIMES is a comprehensive medical device and medical information systems trade show. The show provides substantial exposure for foreign suppliers who are seeking Korean contacts. Available Market Research There are several PMR reports on medical devices in the MRL Dental Equipment and Materials Implants Cardiovascular Industry GMP/GIP regulations on medical devices Cosmetic laser equipment. U.S. Commercial Service Contact Information Name Yoon Shil Chay Position Senior Commercial Specialist Email yoonshil.chay #x40 N0SPAM. trade.gov Phone +82-2-397-4439 Global Healthcare Technologies Team Philippines Capital Manila Population 90.5 million 2008 estimate GDP* $173.2 B 2008 estimate Currency Philippine Peso PhP Language Pilipino and English Summary The medical equipment sector continues to present good opportunities for U.S. firms. Total imports increased by more than 16% from $177 million in 2006 to $206 million in 2007. The medical industry in the Philippines is almost totally dependent on imports. Additional requirements for medical services new technology and equipment replacement spur market growth. Philippine medical tourism continues to grow and offer good opportunities for U.S. sellers of medical equipment and instruments. The Philippine medical market is partial to American products. U.S.-trained Filipino doctors prefer the high technology of American medical equipment and instruments despite their higher costs. American brands face increasing third-country competition notably the Chinese. Market Entry Foreign suppliers appoint licensed distributors to represent their interests in the country. The distributors handle all aspects of importation from product registration obtaining a license or clearance and release of the shipment to actual distribution. Most distributors prefer exclusive contracts with foreign manufacturers. Distributors not only help facilitate the product's entry into the market they also take care of advertising and promotion. Distributors register non-radiation medical devices with the Department of Health’s Bureau of Health Devices amp Technology and refer radiation-emitting devices to the Philippine National Research Institute for clearance and local testing. Hospitals purchase their equipment from distributors or buy directly from suppliers. Private and public hospitals deal only with Department of Health-licensed distributors to guaranty on time delivery and parts and services warranties. Most equipment carries a one year warranty. The Philippines imposes an average of 3% tariff duty and a 12% value-added tax VAT on imported medical equipment. Current Market Trends Medical tourism is a fast growing industry in the ASEAN region the Philippines is ranked fifth in medical tourism in Asia. Local officials and advocates of the program in the Philippines note that local medical facilities and most health practitioners could be as good as any in the United States and in Europe. Philippine curricula for medical and nursing schools are patterned after the United States and many doctors take further studies and train in the U.S. Global Healthcare Technologies Team Main Competitors In 2007 the Philippines’ total import of medical equipment was $206 million. China was the top supplier with a 50% market share. The U.S. was second at about 16% followed by Singapore 8% Germany 7% Japan 6% and The Netherlands 3% . More than 84% of the Philippines’ importation of Medical Equipment came from these 6 countries alone. Although China has dislodged the US as leading supplier of medical equipment the US still dominates the market for durables machineries and equipment . Singapore which ranked third is the regional base of a number of American and European companies therefore it is quite possible that a substantial amount of “Singapore" equipment actually came from the U.S. Current Demand The growth of Medical Tourism in the Philippines offers many good opportunities for U.S. sellers of medical equipment and instruments. To date the government has accredited 10 hospitals in the medical tourism program all of which offer full service such as major surgeries and complete executive medical check-ups. The most promising subsectors are electro-medical equipment ultrasonic scanning machines X-ray and radiation equipment dialysis instruments and apparatus and medical and surgical instruments for cosmetic surgery. Available Market Research PHILIPPINES Medical Device Regulation.ppt updated for April 22 2009 Webinar U.S. Commercial Service Contact Information Name DEY ROBLES Position Commercial Specialist Email dey.robles #x40 N0SPAM. trade.gov Phone 632-888-6078 Global Healthcare Technologies Team Singapore Capital Singapore Population 4.84 million GDP* US$169.4 billion Currency Singapore Dollar SGD Language English Business Mandarin Malay Tamil Other Summary Demand for healthcare in Singapore is set to grow as the population increases and ages. The island state’s population is likely to increase to 5.5 million by 2020. Demand for state of the art medical technologies is also expected to grow as Singapore strengthens its reputation as the region’s healthcare hub and center for healthcare excellence offering first class healthcare delivery systems and facilities to both its resident population and the international patient market. Singapore serves as a showcase for healthcare delivery and medical technology and is considered the gateway to the regional economies of South East Asia. The three key healthcare strategies Singapore is pursuing are clinical research improving long-term care and moving towards more sophisticated care. The national healthcare plan covers almost 100% of the population. This augurs well for the healthcare industry as Singaporeans all have access to medical care. Market Entry U.S. companies who are new to the market and interested in exporting to Singapore may consider appointing a local distributor to represent their company’s product and services. Given the small market size of the island state most potential distributors would request for exclusive rights to sell the product. They will also likely to ask for distribution rights for the regional South East Asia countries as Singapore serves as a gateway into the region. U.S. exporters of medical equipment should evaluate the suitability of the distributor based on the company’s contacts in the market their product range and whether their products complement that of the U.S. firm. As the sales in the local market increases the U.S. firm can look into setting up an on-going presence in Singapore much like how some large MNCs have set up regional offices in Singapore. This brings the U.S. firm closer to their customers demonstrates their commitment to the region and allows for prompt and enhanced customer service. Current Market Trends Singapore’s public hospitals and specialty centers engage in clinical research with the many pharmaceutical biotechnology and medical technology companies based in Singapore. Singapore’s goal is to become Asia’s premier healthcare hub via the attraction of foreign patients. The target is to treat one million patients by year 2012. There is also an emphasis towards a healthy lifestyle and a focus on preventive care. Doctors here are also pushing ethical and professional standards and it is expected that every major hospital in Singapore will have attained the widely recognized American mark of quality health care. Already several private and public sector hospitals have been accredited by the Joint Commission International JCI the overseas arm of the United States' main hospital accreditation agency. Global Healthcare Technologies Team Main Competitors Major competitors of the U.S. are medical devices from Germany other European countries Japan and Australia. Local production by multinational corporations and indigenous Singapore companies is primarily for export. Current Demand Singapore’s healthcare services are comparable to those of other industrialized nations. The plan is to raise health spending to reach US$1.37billion / S $2 billion a year in the next five years. The Singapore government is focused on moving up the value chain by building up services that assist research and healthcare delivery in Singapore and the region. A total of 23 hospitals and six specialty centers provide a complete spectrum of clinical services from basic health screening to complex quaternary care. Barriers There are no barriers to entry as Singapore is an open economy and a firm believer in keeping trade open. There are no custom duties on medical devices. A 7.0% goods and services tax GST is imposed on all goods sold and services provided locally. Imports are subject to GST but payments are refundable on re-exports. Trade Events Hospital Build Asia 2010 Hospital Build Asia 2010 provides an ideal platform for the healthcare industry across the Asia Pacific region. Exhibitors will showcase products solutions and services across all areas of hospital investment planning designing building operating managing and refurbishing Website http // hospitalbuildasia Available Market Research 1. Singapore Healthcare Overview 2008 – report dated 11/08 2. Singapore Biomedical Sector Overview 2007 – report dated 09/07 U.S. Commercial Service Contact Information Name Luanne Theseira Position Commercial Specialist Email luanne.theseira #x40 N0SPAM. trade.gov Phone 65/6476-9416 Global Healthcare Technologies Team Taiwan Capital Population GDP* Currency Language Taipei 23 million 401 billion New Taiwan Dollar Chinese Mandarin Summary Taiwan’s healthcare market is growing rapidly as the island’s increasingly affluent population has more to spend on healthcare. In Taiwan most of high-end healthcare products are imported from overseas. The national healthcare insurance program covers 98 percent of the eligible population and provides reimbursement for a wide range of therapies. However the system is under critical financial strain and the implementation of the so-called “Global Budget Program” is ushering in more stringent reimbursement pricing that may slow the growth of the market especially at the high end. Market Entry According to statistics from the Taiwan Department of Health DOH health in Taiwan has improved dramatically over the past several decades. Its crude death rate fell from 951 per 100 000 in 1952 to only 608 in 2007. Life expectancy for women increased from 56 in 1951 to 82 in 2007 and for men the increase was from 53 to 75 during the same period. Meanwhile fertility rates number of children per 1 000 reproductive age women dropped from 7 040 in 1951 to only 1 680 in 2007. Current Market Trends Taiwan's healthcare sector will face sharp challenges because of the island’s aging population which translates to higher health care costs with fewer productive people to support them. The percentage of people in Taiwan aged 65 and above increased from 2.4% in 1960 to 10.4% in 2007 and is forecast to reach 15% by 2020. In Taiwan people aged 65 and over make four times more visits per year to doctors 25.5 per person per year . They are also hospitalized seven times more often. In fact 9% of older patients eat up 25% of the total budget of the National Health Insurance program which covers over 98% of Taiwanese. However Taiwan’s aging population will also create numerous healthcare business opportunities for those companies that provide products and services focusing on the special healthcare needs of the elderly. Main Competitors Foreign firms supply most of the local demand for healthcare products. U.S. firms dominate the Taiwan market for medical devices pharmaceuticals biotechnology products and natural products with strong brand awareness sales networks distribution and training. U.S. products have been recognized by local end-users as technologically superior of high quality and more durable than other competing products. The major factors impeding the growth of U.S. market share are the higher prices of American equipment and relatively stronger promotional efforts by other foreign competitors from Japan and European countries. Global Healthcare Technologies Team Current Demand Healthcare industry experts say that to improve and sustain the quality of Taiwan’s healthcare the government is going to have to increase healthcare spending which could create business opportunities. Currently Taiwan only spends 6.3% of GDP on health care US$1 440 per person per year . By contrast the U.S. figure is 15.3% US$6 102 per person per year . For developed countries only South Korea’s spending on healthcare at 5.6% of GDP is lower than Taiwan. Industry experts say that to bring Taiwan up to par with the average for other developed nations the island should rise healthcare spending to 9% of GDP. Healthcare industry experts also say that Taiwan should also focus more on preventive healthcare and maintaining a healthy lifestyle. Barriers The Department of Health DOH is the local healthcare authority that regulates the importation of biotechnology pharmaceutical medical devices and medicated cosmetic products. Under the Pharmaceutical Affairs Law all products are required to obtain premarket registration approval from the DOH before they can be imported to Taiwan. Since the DOH issues licenses only to locally registered companies all foreign suppliers must submit required documentation and receive necessary approvals through their Taiwan importers or their Taiwan-registered subsidiaries. Moreover importers must obtain DOH’s premarket registration approval in order to receive an import license from the Board of Foreign Trade Ministry of Economic Affairs. Trade Events Name of event MEDIPHAR Taipei – Taipei International Medical Equipment amp Pharmaceuticals Show November 5-8 2009 and November 8-11 2010 Location Taipei World Trade Center Exhibition Hall Taipei Taiwan English language website taipeiTradeShows .tw/Mediphar Description This event provides U.S. firm with an effective promotional vehicle in the Taiwan market. It includes medical equipment amp instruments hospital supplies diagnostic medical materials bio-tech products pharmaceuticals health care products and rehabilitative products etc. Available Market Research Taiwan Regulatory Environment of Medical Devices 2008 Taiwan Natural Products Industry 2008 U.S. Commercial Service Contact Information Name Angeli Chou Position Commercial Specialist Email angeli.chou #x40 N0SPAM. trade.gov Phone 886-2-27201550 ext. 310 Global Healthcare Technologies Team Healthcare Technologies Resource Guide PDF 997KB Home Events Industry Information Market Research Master Matrix for Healthcare Resource Guide Healthcare Technologies Resource Guide Healthcare Worldwide Trade Leads Medical Financing Programs Our Services Links Contact Us e-Market Express Our Worldwide Sites Export.gov Trade Portal Search Printable version copy 2001-2011 All rights reserved Privacy Policy Disclaimer USA.gov ITA DoC BuyUSA reg Wikia Skip to Content Skip to Wiki Navigation Skip to Site Navigation Wikia Navigation Start a wiki Entertainment What's on TV Pretty Little Liars White Collar Covert Affairs Teen Wolf More... 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