On August 30, 2011, the Medical Device Regulatory Forum held in Beijing. Member of the party commission and deputy director of the State Food and Drug Administration Bureau, Mr. Bian Zhenjia, attended the meeting and delivered a speech. People in charge and relevant personnel from the Policy and Regulation Department, the Department of Medical Device Supervision, National Institutes for Food and Drug Control, Medical Device Standard Management Center, Drug Certification Center, Center for Drug Evaluation, and Center for Medical Device Evaluation also attended the meeting. All units and departments reported on the recent work and carried out in-depth discussions on the current situations, the current problems and the next-step tasks.

 

　　Mr. Bian Zhenjia said that since beginning of this year, the relevant departments and units of the medical device regulatory authorities under the National Bureau have been actively seeking solutions and ideas and taking effective measures according to the functions and work requirements, and based on their actual conditions, to implement the deployments and work plans of the party organizations of the Bureau, and have achieved good results. In particular, the problem of overlong medical device review and approval process was basically solved. However, with advances in medical technology, the diversified development of the medical industry, and the diversification of the production mode of the medical industry, medical device supervision work is facing many new opportunities and challenges; the medical device regulatory system, registration management system, inspection system, information technology and many other aspects remain to be perfected, and the monitoring team and their capabilities are yet to be further strengthened.

 

　　Bian Zhenjia stressed that all departments and units should make in-depth analysis of the situations confronting the medical device regulatory work, actively seize and make good use of the important opportunities for development brought by the 12th Five Year Plan, properly handle the risks and challenges, take efforts to improve the safety level of protection of medical devices. In terms of the regulatory approaches, we should nurture the awareness of innovation, effectively change our views, adjust the regulatory focus, and attach importance to the implementation of key products supervision; we should stress policy effectiveness, increase training efforts, strengthen the construction of talent teams, effectively improve the regulatory capacity, refine emergency management measures, carefully carry out emergency management, strengthen policy research, and fulfill researches on the strategies for medical devices supervision. In terms of the management mechanism, the units and departments of the National Bureau should further strengthen the regulatory guidance for local organizations, further improve the communication and coordination mechanism, and form a joint force for supervision.

 

　　Bian Zhenjia required that the units should carefully comb the measures and opinions proposed at the meeting, profoundly study the situations and tasks facing the medical supervision units, and put forward short-term and long-term improvement measures, to ensure the healthy and sustainable development of medical supervision.