Jun 17, 2020

China’s Center for Medical Device Evaluation (CMDE) issued two announcements recently outlining revised procedures relating to medical device registration.

Increased standardization of filing review process

CMDE Announcement No. 16 of 2020 [links are in Mandarin] establishes procedures and requirements that provide further standardization of the administrative filing review for registration applications, including the acceptance of corrections. This complements the initial batch of filing review requirements laid out in Announcement No. 42 of 2019, which began trial implementation on September 1, 201​9.

New withdrawal and re-submission procedures for up-classified devices

CMDE Announcement No. 17 of 2020 stipulates registration withdrawal and re-application procedures for imported medical devices that were submitted for registration as Class II device​s but upon technical review were found to fall into Class III.

In such cases, the CMDE will issue a medical device/IVD reagent non-approval document stating the reasons for the non-registration. A copy of this document is required to be included in the documents submitted during the re-application process, along with an explanation of the circumstances leading to the re-application. The application fee already paid for Class II registration will be applied toward re-registration, and the applicant will be required to pay the remainder of the Class III fee.

Learn more about medical device regulation in China with 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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