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The 8th China International Medical Device Regulatory Forum (CIMDR) was held in Hangzhou


The 8th China International Medical Device Regulatory Forum

was held in Hangzhou in August. Xiao Hong, deputy director general of China Food and Drug Administration, attended the forum and delivered a speech.

Xiao Hong pointed out that in recent years, the innovation of global medical device were developing vigorously, which had become the important power to lead the changes of medical model and the technical progress of medical treatment. China Food and Drug Administration was shouldering an important task that was to protect the safety of medical devices used by Chinese peoples, actively promoting the reform of the medical devices review and approval system, and achieving positive results in improving the quality and efficiency of review and approval, encouraging the innovation and R & D of new product and technology. Next, it will deepen the reform continuously, strengthen the full life cycle management of medical devices, implement the legal responsibility of enterprises on the full process and life cycle. These have included design and development, clinical trials, production and sales, product recall, adverse event reports and more.

At this forum:

leaders of Medical Device Registration Division, Medical Device Regulatory Division, International Cooperation Division, Standard Management Center, Evaluation Center, Device Review Center, Complaints and Reporting Center and other Divisions of China Food and Drug Administration interpreted China’s medical device regulatory policies and situation of international cooperation. Leaders of medical device regulatory authorities from the United States, Ireland, Saudi Arabia, Japan and other countries and regions stated the progress on medical device regulatory efforts of the relevant countries and regions. Experts from Chinese and foreign industries exchanged their understanding and practical experience of global regulatory regulations. In addition to the general meeting, 16 sub-forums about hot spots in the industry were set up. A Forum about medical device clinical trial. The Forum about post-marketing regulation and verification of medical device. A Forum about risk management and adverse event monitoring of medical device. The Forum about biology evaluation of medical device. Forum about innovation technology and product of medical device and others. More than 700 representatives from Chinese and foreign medical device regulatory authorities, technical institutions and industry attended the meeting.

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