From September 17 to 19, 2019, the 16th Management Committee Meeting of the International Medical Device Regulators Forum (IMDRF) was held in Yekaterinburg, Russia. Ten countries and regions including China, Russia, the United States, the European Union, Japan and the Republic of Korea attended the meeting as members of the Management Committee, and the World Health Organization participated the meeting as an official observer. Xu Jinghe, the Deputy Director of National Medical Products Administration (NMPA), led a delegation to participate in this meeting.
At the meeting, the Chinese delegation reported to the Management Committee on the progress of the coordination project of “Clinical evalsuation of Medical Device” led by China as the chair country. By common consent, the meeting approved the three guidance documents of “Clinical Evidence - Key Definitions and Concepts”, “Clinical evalsuation” and “Clinical Studies” prepared by the working group. This is the first guidance document led, organized and prepared by China’s drug regulators since China joined IMDRF.The Management Committee also endorsed the extended project of “post-marketing clinical follow-up study” proposed by the working group led by China.
The above-mentioned achievements indicate that China’s drug regulators are contributing more Chinese wisdom to the global medical device supervision. In the future, China’s drug regulators will continue to share the experience accumulated in the reform and innovation of review and approval system of medical device in China with the members of IMDRF through the platform of IMDRF, and devote their efforts to further promote the coordination of global medical device regulatory regulations and improve the regulatory ability and level of medical devices in China.
