Representative of Center for Medical Device Evaluation Participated in Face-to-Face Meeting Organized by GRRP Working Group in Japan

  • 2018-12-24
Approved by the China Drug Administration, the Center for Medical Device Evaluation has sent several staff to Japan to participate in the face-to-face meeting organized by IMDRF Good Regulatory Review Practices (GRRP) working group from December 10 to 13, 2018. They will work with nearly 20 representatives from the United States, Japan, Australia and other member states in jointly conducting researches on the coordination mechanism of international pre-market reviews.

As a working group under the IMDRF Forum, GRRP is responsible for better harmonizing of international pre-market reviews by developing a series of pre-market review documents. The working group has issued the Requirements on Responsibility, Training and Behavior for Reviewers” which specified unified requirements for personnel working in International Medical Device Evaluation Agency. In addition, the working group has further regulated and researched medical device products, third-party review bodies and single review (MDSRP).

During this face-to-face meeting, the Basic Principles for the Safety and Effectiveness of Medical and Diagnostic Devices and Identification Requirements of Instruction for Use for Medical and Diagnostic Devices were finalized. Representatives from China voiced their comments and suggestions on the definition of disposable and reusable medical devices, identification for the identity of accessory manufacturers, as well as the relationship between trade name, product name and generic name. The meeting also witnessed a heated discussion on Acceptance Requirements and Procedures for Pre-Market Reviews of Medical Devices. Placing a high premium on this single review document, representatives from China put forward suggestions on information sharing, feedback mechanism, unification of evaluation, simulation tests, and relevant laws and regulations, all of which won the appreciation by the participants. In particular, their opinions on the internationally accepted guiding principles based on Regulated Product Specification (RPS) have been unanimously recognized. Participants also discussed the status quo of supervision by third-party review bodies in member states.

This was the first time that the IMDRF China Working Group was involved in a face-to-face meeting overseas. The representatives from China proposed a Chinese approach for the international coordination of technology review of medical devices, receiving positive responses from the participants. As a result of deep participation in the formulation of international rules, representatives from China have achieved a faster transition from learning to active participation. On the other hand, they also accumulated experience for further participating in international regulation of medical devices.