Dec 18, 2020
China’s National Medical Products Administration (NMPA) published a number of guidance documents pertaining to medical devices and IVDs recently. Noteworthy examples include guidelines on real-world data for clinical evaluation, generic naming of medical devices, and technical review of IVDs.
Announcement No. 77 of 2020 (links in Chinese) featured technical guidelines on the application of real-world data in the clinical evaluation of medical devices and IVDs for registration in China. The guidance includes discussion of the advantages and limitations of real-world research, common real-world data sources, and evaluation of the quality of real-world data for inclusion in clinical evaluation.
The NMPA also released an "interpretation" of the technical guidelines to accompany this new guidance and further summarize and explain the related concepts.
In Announcement No. 79 of 2020, the NMPA published several new guidelines for the generic naming of the following specific types of medical devices:
Finally, Announcement No. 80 of 2020 contained several new technical review guidelines for the registration of the following IVDs:
UDI compliance deadlines for some Class III devices in China pushed to early 2021
Preview of new human factors usability testing guidance coming from Chinese medical device regulator NMPA
The Center for Medical Device Evaluation (CMDE) published two announcements relating to the filing review process and device up-classification to Class III.
China’s NMPA, CMDE, and Ministry of Commerce have taken steps to balance supply needs with quality concerns.