sino waypoint consulting inc. 1 wenqin shao sino waypoint consulting inc. china medical device...
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Sino Waypoint Consulting Inc.Sino Waypoint Consulting Inc. 1
Wenqin Shao
Sino Waypoint Consulting Inc.
China Medical Device Industry
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• China is a market unlike any others
• Second largest economy in the world
• GDP of over USD 6.9 trillion in 2007
• GDP has grow on average 9.9% per year
• Per capita income has grown at average 8%
China Market Overview
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China Key Market Zones
1.1.Bohai Bay Loop (Beijing, Tianjing, and Bohai Bay Loop (Beijing, Tianjing, and northeastern areas)northeastern areas)
2.2.Yangtze River Delta (Shanghai, JiangSu, Yangtze River Delta (Shanghai, JiangSu, ZheJinag)ZheJinag)
3.3.Pearl River Delta (GuangZhou)Pearl River Delta (GuangZhou)
• 100 cities with 1 million people or more100 cities with 1 million people or more
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Medical Device Industry
• One of the fastest growing marketsOne of the fastest growing markets
• Market size: USD $12.96 billion in 2006Market size: USD $12.96 billion in 2006
• 12,000 Medical devices manufactures12,000 Medical devices manufactures
• 62% private, 37% JVs and 1% SOEs62% private, 37% JVs and 1% SOEs
• Industrial output value above USD $5.75 Industrial output value above USD $5.75 billion in 2006 with growth rate at billion in 2006 with growth rate at 27.44%27.44%
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USD 3.7 billionUSD 3.7 billion
Import value
USD 6.9 billionUSD 6.9 billion
Export Value
175,000175,000
Domestic hospital and Clinics
145,000145,000
Distributors and agencies
1.6 million1.6 million
Registered doctors and surgeons
2006 trade figures
2006 trade figures
2006 Trade Figures
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Market Entry
1. State Food and Drug Administration (SFDA)
2. State General Administration of Quality Supervision
3. Inspection and Quarantine of the People’s Republic of China
Comply with regulation and laws imposed by the following administrations
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• 6th largest market in the world
• Estimated at USD 1.5 billion growth at 30%
• 13,000 automated Labs and 5,000 semiauto Labs, projected growth at 15% per year
• 200 IVD product manufacturers provide 60% of domestic market needs
China IVD Market
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• Hospital system reform and Increased availability of healthcare insurance
• Increased consumer power and equipment purchase by hospitals and clinics
• Increased desire for utilization of advance technology
• Growth desire for better quality of care
• Revised regulations on medical devices
Market Growth Factors
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Class I:
Devices whose safety and effectiveness can be ensured through routine administration, they don’t need to do the Type Testing in China
Class II: Class III:
Devices whose further control is required to ensure their safety and effectiveness, need to go through the Type Testing in China
Devices which are implanted into the human body or used for life support or sustenance or pose potential risk to the human body, must be strictly controlled in respect to safety and effectiveness
Product Registration
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• Product registration is required by the State Food and Drug Administration
• Product registration is required for all import Medical Devices from Class II and III
• Product registration has 4 year validity and re-registration is required after expiry
Product Registration
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Domestic, 43,487
Imported, 12,156
35,559
20,084
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
Class I & II Class III
Total 55,643 Domestic: 43,487 Imported: 12,156 Class I & II: 35,559 Class III: 20,084
In 2006-11,724 Certificates Class I: 3,170 Class II: 5,239 Class III: 1,231 Imported:2,045
Product RegistrationRegistered in China (2000 -2006)
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• China fully accessed to WTO’s membership requirements in 2007
• Under IP laws and regulations fully alighed with trade Related Intellectual Property Treaties
• China has signed most of the international treaties and conventions on IP protection
• China is member of the world intellectual property Organization
Intellectual Property Right
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• Trade marks should be filed with the China trademark Office
• Copyrighted works do not require registration for protection, however you may wish to register with China national copyright administration on a voluntary basis
• Unfair competition falls under the responsibility of the Fair Trade Bureau under the State Administration for Industry and Commerce
Intellectual Property Right
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• China’s Legal System actively process infringement laws suits
• There were 37,499 cases relating to trademark irregularities that were processed
• China is the third largest country in terms of the number of IPR infringement cases filed in 2007
• 5,745 tons of pirated commodities (estimated at RMB 242 million) were destroyed
Intellectual Property Right
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Gather leading M.D. player from China
and world Gateway for
Foreign M.D. to enter China
Gather Key Opinion
Leaders
Twice a year
Bring business experience in China
China International Medical China International Medical Equipment Fair Equipment Fair
China’s largest M. D. Event
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Contact Information
Wenqin Shao
613-761-8118