The NMPA published twelve guidelines on December 9, 2020. Among all the guidelines, seven of them are for IVD products and five are for nomenclature. Among these, they have introduced important adjustments to the contents of the Classification Catalogue of Medical Devices for 28 classifications of medical devices. This includes management of 15 classifications of medical devices and catalogue contents of 13 classifications of medical devices.

Implementation requirements have been described as below:

1. 1. Since the date of this Notice, the drug supervision and administration department will accept the application for registration and filing of medical devices according to the adjusted classifications.
2. 2. For medical devices that have been accepted but not yet completed the registration approval (including first registration and renewal registration), the drug supervision and administration department shall continue to review and approve in accordance with the original acceptance classification. If the registration is approved, the certificate shall be issued, and the adjusted product management classification shall be indicated in the remark column of the certificate.
3. 3. For registered medical devices, if the management category is adjusted from Class III to Class II (from Class II to Class I), the medical device registration certificate shall remain valid within the period of validity.

In case of renewal, the registrant shall apply to the relevant drug supervision and administration department for renewal, in accordance with the changed category 6 months, prior to the expiration of validity period of the registration certificate. If the registration is approved, the medical device registration certificate shall be issued according to the adjusted product management classification. Before the expiration of the registration certificate, the registrant may apply to the related drug supervision and administration department for product filing, and if the filing information meet the requirements, the drug supervision and administration department shall make the filing certificate in accordance with the relevant requirements and release the information in the filing information form on its website.

4. Where any registration change occurs within the validity of medical device registration certificate, the applicant shall apply for the registration change to the original registration department.

Summary of opinions on product management classification
adjustment of the Classification Catalogue of Medical Devices