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.
Procedure for Modification
This draft document proposes the procedure as follows:
- Overseas manufacturers submit “Classification Catalogue” suggestions to the Center for Medical Device Standardization Administration (CMDSA)
- Domestic manufacturers submit suggestions to provincial NMPA where they are located. If the adjustments are deemed necessary, the proposal shall be submitted to the CMDSA by provincial NMPA.
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.
Application Scope for Modification
The document also lists the areas that can be modified:
- catalogue framework
- product classification and managerial catalogue of Class I products, Class II
- supplement of typical medical devices
- products to be deleted that are no longer managed as medical devices
- Revision of the product description, the intended use and the sample name of the product
Materials for Modification
The proposal is to require the manufacturers to submit the following materials along with the modification suggestions:
- Content and reasons for the proposed amendment;
- Domestic and foreign product management attributes, classification and industrial status;
- Main risk points and risk changes of the product;
- Product technical characteristics, comparison with approved predicates, and clinical use of the product;
- Adverse events of products and related post-marketing supervision status (if applicable).
Key Takeaways for Registered Manufacturers
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.