China Medical Device Industry Wenqin Shao Sino Waypoint

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

China Market Overview • 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% Sino Waypoint Consulting Inc. 2

China Key Market Zones 1. Bohai Bay Loop (Beijing, Tianjing, and northeastern areas) 2. Yangtze River Delta (Shanghai, Jiang. Su, Zhe. Jinag) 3. Pearl River Delta (Guang. Zhou) • 100 cities with 1 million people or more Sino Waypoint Consulting Inc. 3

Medical Device Industry • One of the fastest growing markets • Market size: USD $12. 96 billion in 2006 • 12, 000 Medical devices manufactures • 62% private, 37% JVs and 1% SOEs • Industrial output value above USD $5. 75 billion in 2006 with growth rate at 27. 44% Sino Waypoint Consulting Inc. 4

2006 Trade Figures Import value Export Value USD 3. 7 billion 1. 6 million USD 6. 9 billion 175, 000 Domestic hospital and Clinics Sino Waypoint Consulting Inc. 2006 trade figures Registered doctors and surgeons 145, 000 Distributors and agencies 5

Market Entry w Comply with regulation and laws imposed by the following administrations 1. State Food and Drug Administration (SFDA) 2. State General Administration of Quality Supervision Sino Waypoint Consulting Inc. 3. Inspection and Quarantine of the People’s Republic of 6

China IVD Market • 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 Sino Waypoint Consulting Inc. 7

Market Growth Factors • 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 Sino Waypoint Consulting Inc. 8

Product Registration Class I: Class II: Devices whose safety and effectiveness can be ensured through routine administratio n, they don’t need to do the Type Testing in China Devices whose further control is required to ensure their safety and effectiveness , need to go through the Type Testing in China Sino Waypoint Consulting Inc. Class III: 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 9

Product Registration • 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 reregistration is required after expiry Sino Waypoint Consulting Inc. 10

Product Registration Registered in China (2000 -2006) Total 55, 643 w Domestic: 43, 487 w Imported: 12, 156 w Class I & II: 35, 559 w Class III: 20, 084 In 2006 -11, 724 Certificates w Class I: 3, 170 w Class II: 5, 239 w Class III: 1, 231 w Imported: 2, 045 Sino Waypoint Consulting Inc. 11

Intellectual Property Right • 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 Sino Waypoint Consulting Inc. 12

Intellectual Property Right • 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 Sino Waypoint Consulting Inc. 13

Intellectual Property Right • 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 Sino Waypoint Consulting Inc. 14

China International Medical Equipment Fair China’s largest M. D. Event Bring business experience in China Gather Key Opinion Leaders Gather leading M. D. player from China and world Gateway for Foreign M. D. to enter China Twice a year Sino Waypoint Consulting Inc. 15

Contact Information Wenqin Shao 613 -761 -8118 Wenqin_shao@siwyc. com Sino Waypoint Consulting Inc. 16