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.
Applying real-world data to medical device and IVD clinical evaluation
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…