China: MD Classification Revision & UDI for Selected Device Categories

Two important announcements were made by Chinese authority regarding regulation of medical devices


1.China NMPA has announced in Announcement No. 147 of 2020 that contents of the "Medical Device Classification Catalogue" of 28 types of medical devices will be adjusted. This will include down-classification of 15 devices and revisions to 13 other devices implemented from 31 December 2020

  • All new filings and registrations must be submitted according to the adjusted classifications.

  • Initial registrations and renewal applications that are accepted, but not approved yet will be reviewed and approved according to the previous submission guidelines, and the registration certificate will indicate the adjusted classification.

  • For all registered devices, the registration will remain valid until expiry.

  • For any changes during validity period, applications must be made following the original classifications and the registration certificate will indicate the adjusted classifications.

2. The Center for Medical Device Evaluation (CMDE) has provided detailed guidelines on submission of unique device identifier (UDI) data in the eRPS system. A list of the device categories currently subject to UDI requirements have been provided as an attachment to the announcement. Applicants with devices that fall under this list must follow the guidelines during submission of registration, renewal or modifications.



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