NMPA Medical Device Classification Catalogue is Modified

NMPA released the updated Amendment of Medical Device Classification Catalogue on December 31, 2020, providing modification on management category and catalog content.

Modified Content

The contents of medical Device Classification Catalogue for 28 categories of medical devices are adjusted, among which 15 management categories of medical devices are adjusted , and the contents of 13 categories of medical devices are adjusted.

Impact on Manufactures

From December 31, 2020, NMPA will accept applications for registration and filing of medical devices according to the updated Classification Catalogue.

For medical devices that have been accepted and have not approved (including the initial and renewal registration), NMPA will continue to review and approve the medical devices according to the original accepted category, and issue the medical device registration certificate but and indicate the updated management category will be indicated in the remarks column of the registration certificate.

For the approved medical devices, the medical device registration certificate shall remain valid within the validity period. If renewal is required, application and renewal registration or filing shall be made according to the updated Classification Catalogue.

Brady can evaluate the gap between the “Classification Catalogue” amendment and your product and help you with your registration.

Link: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20201231154216161.html