 Sino Waypoint Consulting Inc. 1 Wenqin Shao Sino Waypoint Consulting Inc. China Medical Device Industry

 Sino Waypoint Consulting Inc. 2 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

 Sino Waypoint Consulting Inc. 3 China Key Market Zones 1.Bohai Bay Loop (Beijing, Tianjing, and northeastern areas) 2.Yangtze River Delta (Shanghai, JiangSu, ZheJinag) 3.Pearl River Delta (GuangZhou) 100 cities with 1 million people or more100 cities with 1 million people or more

 Sino Waypoint Consulting Inc. 4 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 ,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 billion in 2006 with growth rate at 27.44%Industrial output value above USD $5.75 billion in 2006 with growth rate at 27.44%

 Sino Waypoint Consulting Inc. 5 USD 3.7 billion Import value USD 6.9 billion Export Value 175,000 Domestic hospital and Clinics 145,000 Distributors and agencies 1.6 million Registered doctors and surgeons 2006 trade figures 2006 trade figures 2006 Trade Figures

 Sino Waypoint Consulting Inc. 6 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

 Sino Waypoint Consulting Inc. 7 6 th 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

 Sino Waypoint Consulting Inc. 8 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

 Sino Waypoint Consulting Inc. 9 Class I: Devices whose safety and effectiveness can be ensured through routine administratio n, 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

 Sino Waypoint Consulting Inc. 10 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

 Sino Waypoint Consulting Inc. 11 Total 55,643  Domestic: 43,487  Imported: 12,156  Class I & II: 35,559  Class III: 20,084 In ,724 Certificates  Class I: 3,170  Class II: 5,239  Class III: 1,231  Imported:2,045 Product Registration Registered in China ( )

 Sino Waypoint Consulting Inc. 12 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

 Sino Waypoint Consulting Inc. 13 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

 Sino Waypoint Consulting Inc. 14 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 ,745 tons of pirated commodities (estimated at RMB 242 million) were destroyed Intellectual Property Right

 Sino Waypoint Consulting Inc. 15 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 Equipment Fair China’s largest M. D. Event

 Sino Waypoint Consulting Inc. 16 Contact Information Wenqin Shao