Jul 21, 2021

China’s National Medical Products Administration (NMPA) has initiated a public consultation (link in Chinese) on the optimization of mandatory standards for medical devices. Specifically, the NMPA is seeking feedback on its optimization and evaluation conclusions following a review of 93 national standards and 303 industry standards, as well as of 62 existing standard formulation and revision projects.

Further details are available in the lists of these standards and projects and in their accompanying assessment findings, provided as attachments to the consultation announcement. The NMPA will accept stakeholder feedback via email until July 30, 2021. ​

More resources on Chinese medical device regulation from Emergo by UL:

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

Author

  • Timothy Herr

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