IMDRF is an important cooperative organization among medical device regulatory agencies in major countries in the world, aiming to accelerate the coordination and integration of international medical device supervision. In March 2018, the new project “Medical Device Clinical Evaluation” proposed by NMPA was successfully established at the 13th Management Committee meeting of IMDRF, meanwhile, a working group was set up to complete the project, chaired by the member of NMPA. In March 2019, the drafts of “Clinical Evidence - Key Definitions and Concepts”, “Clinical Evaluation” and “Clinical Trials” prepared by the working group were successfully established at the 15th Management Committee meeting of IMDRF and were published on the official website of IMDRF on April 5. Furthermore, the comment period provided for global medical device regulatory agencies and industry stakeholders is two months. After the consultation, the working group timely collected feedback, conducted in-depth research, and actively communicated through telephone conferences, e-mails, etc., which laid a solid foundation for the meeting.
During the meeting, the members of the working group conducted in-depth discussions on the feedback and frankly exchanged their ideas and opinions. The atmosphere of the meeting was warm and friendly. In this meeting, the members of the working group basically agreed on the handling of the feedback, and revised the above-mentioned drafts based on the feedback adopted. The final documents would be submitted to the IMDRF Management Committee for review by the Chinese chairman of the working group and were expected to be approved for release at the 16th Management Committee meeting of IMDRF in September. In this meeting, the meeting also discussed the possible outreach projects of the working group. The meeting decided that the working group will select the appropriate project to submit to the IMDRF Management Committee for review and approval.
The outcome document of the project, which coordinates and integrates the clinical evaluation requirements of IMDRF member countries, will be conducive to accelerating the simultaneous global marketing of safe and effective innovative medical devices, and achieving a win-win situation for medical device regulators and the industry. By means of IMDRF, NMPA shared the experience accumulated in recent years with the members of IMDRF, indicating that related concepts of Chinese medical device regulation have been preliminarily recognized internationally, which contributed Chinese wisdom to further promote the scientific, rational and standardized clinical evaluation of global medical devices.