Jun 17, 2020
China’s Center for Medical Device Evaluation (CMDE) issued two announcements recently outlining revised procedures relating to medical device registration.
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, 2019.
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 devices 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.
China’s NMPA, CMDE, and Ministry of Commerce have taken steps to balance supply needs with quality concerns.
Several regulatory bodies have eased import restrictions and expedited registration processes for needed goods.
The regulator clarifies principles employed by the NMPA that affect all medical device registrations in the country.