Healthcare Technologies Resource Guide - Export.gov

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20 driving factors include demand for better healthcare services, the increasing aging population, and the improved and full medical coverage for all nationals .Recently, the Ministry of Health (MOH) has issued the notice to promote the development of nonpublic medical institutions to meet the shortage of medical resources, requiring giving priority approval should be given to privately-invested medical institutions that meet entry standards when adjusting or increasing new healthcare resources. It stated that by 2015 the number of beds and services should account for about 20% of the total. This will lead to greater needs for medical equipment in the future. Main Competitors Depending on the specific type of products, foreign competitors are those from EU or Japan as their respective markets for healthcare are structured and well developed. Current Demand Chinese end users consider U.S. products to be of superior quality and most technologically advanced. China’s hospitals particularly welcome medical equipment and products with high content of technology. At the same time, domestic medical device companies are consolidating, upgrading quality, and beginning to compete in medium-level technology niches. Registration Process All imported medical devices are required to register with the State Food and Drug Administration (SFDA) before being sold in the Chinese market. The SFDA has a comprehensive system for medical device registration and inspection, which includes product type testing and factory audits. Medical devices are divided into three classes depending on levels of risks similar to but stricter than that of USFDA. Clinical trials are required for registration of Class III and some Class II medical devices. The process normally takes from one to three years. 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. Additionally, pricing, tender, and bar code systems also play a role of delaying a company’s entry into the Chinese medical device market. Trade Events China Med 2013 March 28–30 • Beijing • www.chinamed.net.cn/en One of the most influential exhibitions in Chinese medical instruments and equipment industry. China International Medicinal Equipment Fair (CMEF) 2012 Autumn October 18–21 • Chengdu, Sichuan China International Medicinal Equipment Fair (CMEF) 2013 Spring Date TBD • Shenzhen • cmef.com.cn/en Founded in 1979, CMEF is held twice a year in Spring and Autumn. CMEF has become the largest exhibition of medical equipment and related products and services in the Asia-Pacific region. U.S. Commercial Service Healthcare Technologies Resource Guide | 2012–2013
MEDTEC China 2013 September • Shanghai • medtecchina.com/index.php?page=home-en Allows manufacturers access to the latest technologies, techniques, and equipment. Experts now attend MEDTEC China on an annual basis to view and learn, to meet suppliers, and to attend seminars. Care & Rehabilitation Expo China 2013 November • Beijing • crexpo.com.cn/english China’s largest exhibition focused exclusively on the care and rehabilitation industry. SINO-Dental 2013 June 9–12 • Beijing • sinodent.com.cn/en China’s largest dental exhibition, organized by the Ministry of Health. In 2011, 74241 professionals from 80 countries and regions were in attendance. Available Market Research • Clinical Laboratory Market: buyusainfo.net/docs/x_5325735.pdf • Ophthalmic Equipment and Products Market: bit.ly/NkQbIX • Gynecological Devices and Products: buyusainfo.net/docs/x_3244830.pdf • Pre-hospital Emergency Medical Service and Equipment: buyusainfo.net/docs/x_918621.pdf • Measures for the Administration of Medical Device Registration (English Translation): buyusainfo.net/docs/x_525872.pdf U.S. Commercial Service Healthcare Technologies Resource Guide | 2012–2013 21
Page 1: Healthcare Technologies Resource Gu
Page 4 and 5: iv What Can the U.S. Commercial Ser
Page 6 and 7: 2 Argentina Summary Overall healthc
Page 8 and 9: 4 Australia Summary The medical equ
Page 10 and 11: 6 Austria Summary Austria is a dyna
Page 12 and 13: 8 The Austrian market for medical e
Page 14 and 15: 10 potential. Orthopedic products,
Page 16 and 17: 12 to replace bigger and more expen
Page 18 and 19: 14 • Demand for invasive and noni
Page 20 and 21: 16 Chile Summary As the United Stat
Page 22 and 23: 18 Barriers Chile has a favorable i
Page 26 and 27: 22 Czech Republic Summary The healt
Page 28 and 29: 24 EXPODENT October • Prague •
Page 30 and 31: 26 the best solution, possibly by b
Page 32 and 33: 28 public sector bases most purchas
Page 34 and 35: 30 Current Market Trends Egypt’s
Page 36 and 37: 32 human body solely or principally
Page 38 and 39: 34 Other than the risk assessment s
Page 40 and 41: 36 Coming Soon: New Regulatory Fram
Page 42 and 43: 38 Finland Summary High quality and
Page 44 and 45: 40 France Summary Total market dema
Page 46 and 47: 42 Barriers There are no significan
Page 48 and 49: 44 surgery where, according to an e
Page 50 and 51: 46 Tariffs, Import Regulation There
Page 52 and 53: 48 Trade Events MEDICA with Compame
Page 54 and 55: 50 the private sector’s expenditu
Page 56 and 57: 52 Main Competitors In the Greek ma
Page 58 and 59: 54 Guatemala Summary Present situat
Page 60 and 61: 56 Medical equipment is constantly
Page 62 and 63: 58 distributors handle several bran
Page 64 and 65: 60 India Summary The Indian healthc
Page 66 and 67: 62 The opportunity also exists for
Page 68 and 69: 64 Current Demand Best Prospects
Page 70 and 71: 66 Irish labeling requirements are
Page 72 and 73: 68 Israel Summary U.S. medical devi
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70 Italy Summary Italy is a mature
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72 Strategic areas, in which there
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74 1. The U.S. firm can ask their i
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76 Jordan Summary • Medical Touri
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78 seeking treatment in the Kingdom
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80 Kenya Summary Kenya is the most
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82 Republic of Korea Summary The Ko
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84 Tariffs Tariffs of medical devic
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86 In summary, selecting the approp
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88 Main Competitors Most large inte
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90 The Inspectorate and the RIVM en
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92 New Zealand Summary All New Zeal
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94 Nigeria Summary Nigeria is a net
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96 Norway Summary Norway is one of
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98 The Philippines Summary The medi
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100 The Center for Device Regulatio
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102 locate an appropriate agent/dis
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104 Trade Events SALMED March 2014
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106 component of the Portuguese med
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108 Current Demand For 2011, the Mi
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110 the National Health Project in
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112 Saudi Arabia Summary The Saudi
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114 3. King Faisal Medical City in
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116 Trade Events MEDEXPO Saudi Arab
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118 The Serbian market is very rece
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120 Resources Ministry of health of
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122 Doctors here are also pushing e
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124 Main Competitors Slovakia’s m
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126 Spain Summary According to the
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128 Main Competitors The United Sta
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130 Current Market Trends Two main
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132 Taiwan Summary Taiwan, an islan
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134 Trade Events Taiwan Internation
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136 Medical tourism is a new sector
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138 Ukraine Summary In 2011, the Uk
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140 The Ukrainian market is recepti
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142 Current Market Trends • The U
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144 U.S. Commercial Service Healthc
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146 U.S. Commercial Service Healthc
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148 Certification Reference Chart E
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150 Subsector Reference Chart Ratin
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152 Contacts The U.S. Commercial Se
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154 Vermont Susan Murray—Montpeli
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1208-05-17
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