China – Medical Device Classification Catalogue, manufacture and distribution rule revisions

China’s National Medical Products Administration (NMPA) has issued revisions to the Medical Device Classification Catalog, as well as new provisions for medical device manufacture and distribution. If you are a medical device manufacturer doing business in China, you will want to take note of these new requirements.

The NMPA has issued revisions to the Medical Device Classification Catalog through the following: Announcement No. 25 of 2022 (link in Chinese), which specifies changes for 10 device types, and Announcement No. 30 of 2022 (link in Chinese), which specifies changes for 27 device types. The announcements also outline conditions for implementing the changes.

According to Emergo by UL sources, from the date of each announcement, the following conditions apply:

  • Applications will be processed according to the adjusted classification.
  • For applications that have been accepted but have not yet completed registration approval (including initial and renewal registrations), they will continue to be reviewed and approved according to the original classification. If approved, a registration certificate shall be issued, and the adjusted classification shall be indicated in the remarks column of the certificate…