NMPA guidances address real-world data, medical device naming, and IVD technical review

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.

Generic naming of several medical device categories

In Announcement No. 79 of 2020, the NMPA published several new guidelines for the generic naming of the following specific types of medical devices:

• Orthopedic surgical instruments
• Blood transfusion, dialysis, and cardiopulmonary bypass equipment
• Passive surgical instruments
• Passive implantable devices
• Medical device disinfection and sterilization equipment

Technical review guidelines for certain IVD types

Finally, Announcement No. 80 of 2020 contained several new technical review guidelines for the registration of the following IVDs:

• Household IVDs
• Specific protein immunoassay analyzer
• Prolactin detection reagent
• Total triiodothyronine detection reagent
• 25-hydroxy vitamin D detection reagent
• Serum amyloid A detection reagent
• Rheumatoid factor detection reagent

Related Chinese medical device regulatory information from Emergo by UL:

• China NMPA medical device registration and approval consulting
• China NMPA medical device clinical and testing requirements consulting
• Whitepaper: China NMPA medical device registration requirements
• Webinar: Medical device registration in China