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China Medical Trials & Safety Surveillance

, [Marriott Hotel West] Beijing, China

Beijing, China – The health care sector in China is seeing expansion with the booming industry of international and local medical devices exposing new opportunities in the development and expansion of this emerging market.

Noppen's conference on China Medical Trials and Safety Surveillance was held on 9-10 July 2009 at the Marriott Hotel West. Experienced industry professionals and top China government officials came together to discuss how to optimize trial management, accelerate registration procedures, and monitor adverse events in the industry of medical devices.

Growing attraction from international medical device suppliers to register in China brings about challenges and discussion for solutions to expedite the process. Bai Zhipeng, Secretary General of the China Association of Medical Equipment and member of the China Expert Team in the EU-China Medical Device Expert Roundtable opened the conference with the status and progress of reforms in the medical device industry in China. This included equipment procurement strategies of primary health care sectors and promoting after-sales services in rural areas.

Sun Zhuohui, Medical Product Consultant of the NEMA Beijing Office and also member of the China Expert Team in the EU-China Medical Device Expert Roundtable spoke about registration application and technical evaluation of active and passive medical devices. After the speech, he held an interactive open discussion on medical device evaluation with attendees. Discussion became centred on how to communicate with the State Food and Drug Administration (SFDA) and dealing with the time delays associated with medical device in China.

In addition to widening the Chinese market to medical devices is the need to meet regulatory requirements for safety surveillance. Jack Wong, Vice President of Regulatory Affairs in Asia and General Manager of BSI in Hong Kong and Secretariat of the AHWP Technical Committee covered the topic of developing regulatory strategy in the China Market. Mr. Wong held a forum on accelerating registration procedures in China, including clarifying the regulations and directives of SFDA.

Head of Regulatory Affairs of Roche Diagnostics (Shanghai), Vicky Roche, contributed ideas to address the practical issues of minimizing risks, lowering costs, and improving speed for product registration.

Other topics discussed included China standards of medical device quality supervision and testing, harmonizing medical device regulation, and strategies for the further development of medical device regulation in China.

China Medical Trials & Safety Surveillance

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