National Food and Drug Administration Holds a Symposium on Medical Device Supervision and Management

On August 30, 2011, a symposium on medical device supervision and management was held in Beijing. Bian Zhenjia, a member of the Party Group and Deputy Director of the State Food and Drug Administration, attended the meeting and delivered a speech. The heads and relevant personnel of the Policy and Regulations Department, Medical Device Supervision Department, China Food and Drug Control Research Institute, Medical Device Standard Management Center, Drug Certification Management Center, Drug Evaluation Center, and Medical Device Technical Evaluation Center attended the meeting. Each unit and department reported on their recent work situation and conducted in-depth discussions on current problems and next steps.

Bian Zhenjia believes that since the beginning of this year, relevant departments and units of the National Bureau of Medical Device Supervision have actively worked out methods and ideas, taken effective measures, and conscientiously implemented the various deployments and work plans of the bureau's party group in accordance with their functions and work requirements, combined with their respective actual situations. All work has achieved good results. Especially, the issue of medical device review and approval timeout has been basically resolved. However, with the progress of medical technology, the development of the medical industry, and the diversification of production and operation methods, medical device supervision work is facing many new opportunities and challenges. The regulatory system, registration management system, inspection and testing system, information construction, and other aspects of medical device supervision still need to be improved, and the regulatory team and capacity need to be further strengthened.

Bian Zhenjia emphasized that all departments and units should conduct in-depth analysis of the situation faced by medical device supervision work, actively seize and utilize the important development opportunities of the 12th Five Year Plan, properly respond to various risks and challenges, and strive to improve the level of medical device safety assurance. In terms of regulatory methods, establish innovative awareness and effectively transform concepts; Adjust the regulatory focus and do a good job in supervising key products; Pay attention to policy effectiveness and increase training efforts; Strengthen the construction of talent teams and effectively improve regulatory capabilities; Refine emergency management measures and handle emergency events well; Strengthen policy research and complete the strategic research topic of medical device supervision. In terms of management mechanism, various units and departments of the National Bureau should further strengthen guidance on local regulatory work, further improve communication and coordination mechanisms, and form a joint regulatory force.

Bian Zhenjia requires that all units carefully review the opinions and measures proposed at the meeting, conduct in-depth research on the situation and tasks faced by medical device supervision work, propose short-term and medium to long-term improvement measures, and ensure the healthy and sustainable development of medical device supervision work.