NMPA announced the Procedure of Dynamic Amendment of Medical Device Classification Catalogue (Draft) on November 13, 2020, providing a more risk-based and internationally recognized pathway for medical device classification. Feedbacks need to be submitted by December 15, 2020.
This draft document proposes the procedure as follows:
As a result of the dynamic change, manufacturers are encouraged to apply and correct the device classification. Email ChinaMedDevice.com with your modification suggestions so we can send to CMDSA.
The document also lists the areas that can be modified:
The proposal is to require the manufacturers to submit the following materials along with the modification suggestions:
For the manufacturers who has already registered or is in the registration process in China, the amendment of the “Classification Catalogue” may have a great impact on their China registration.
Where classification management of registered medical device is changed from a higher class to a lower class, the Registration Certificate for Medical Device within the period of validity shall continue to be effective. However, the applicant shall apply for registration extension based on changed classification to corresponding NMPA requirements 6 months before the expiration of registration certificate.
On the other hand, where classification management of registered medical device is upgraded from lower class to higher class, the applicant shall follow relevant provisions and apply for registration to the NMPA according to the requirements on the changed classification. NMPA will release specific timeline on the deadline for completing the change of certificate.
CMD can evaluate the gap between the “Classification Catalogue” and your product and help you with your registration.