Feb 26, 2020

China’s Center for Medical Device Evaluation (CMDE) published Announcement No. 99 of 2019, a guidance document intended to clarify the principles employed by the National Medical Products Administration (NMPA) for determining medical device generic names. This expands upon the rules previously outlined in CFDA Order No. 19. (The China Food and Drug Administration, or CFDA, is the former name of the NMPA.)

Guidance for a shifting regulatory system

NMPA regulations stipulate that the name of any medical device submitted for registration in the country must be the generic name, so the additional guidance should be of use to manufacturers interested in entering the Chinese market. Recent years have seen declining interest in China among some medical device manufacturers, due in part to a regulatory system that is evolving and perceived as increasingly complex. The publication of more explanatory material may help to alleviate this sense of confusion about the market.

Learn more about China NMPA medical device regulatory issues at Emergo by UL:

  • China NMPA medical device registration and approval consulting
  • Medical device clinical and testing requirements assessment for China
  • Process chart: NMPA regulatory approval for medical devices
  • Whitepaper: China NMPA medical device registration
  • Webinar: Medical device registration in China

Author

  • Timothy Herr

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