In order to further deepen the reform of the medical device evaluation and approval system, based on the actual development and regulatory work of the medical device industry, and in accordance with the relevant requirements of the Regulations on the Supervision and Administration of Medical Devices, the National Medical Products Administration has decided to adjust some of the contents of the Classification Catalogue of Medical Devices. The relevant matters are hereby announced as follows:
1、 Adjusting content
Adjust the content of the Medical Device Classification Catalogue for 28 categories of medical devices, including 15 categories of medical device management categories (see Annex 1) and 13 categories of medical device catalogs (see Annex 2).
2、 Implementation requirements
（1） Starting from the date of this announcement, the drug regulatory authorities shall accept medical device registration and filing applications in accordance with the adjusted categories in accordance with the "Measures for the Administration of Medical Device Registration", "Announcement on the Requirements for Publishing Medical Device Registration Application Materials and Approval Document Formats", and "Announcement on Matters Related to Class I Medical Device Filing".
（2） For medical devices that have been accepted but have not yet completed registration approval (including initial and subsequent registration), the drug regulatory department will continue to review and approve according to the original acceptance category. If registration is allowed, a medical device registration certificate will be issued, and the adjusted product management category will be indicated in the remarks column of the registration certificate.
（3） For registered medical devices, if their management category is adjusted from Class III to Class II, the medical device registration certificate will continue to be valid during its validity period. If it is necessary to renew, the registrant shall apply to the corresponding drug regulatory department for renewal of registration according to the changed category 6 months before the expiration of the validity period of the medical device registration certificate. If the renewal is allowed, a medical device registration certificate shall be issued according to the adjusted product management category.
For registered medical devices, if their management category is adjusted from Class 2 to Class 1, the medical device registration certificate will continue to be valid during its validity period. Before the expiration of the registration certificate, the registrant may apply for product filing with the corresponding drug regulatory department. If the filing materials meet the requirements, the drug regulatory department shall prepare filing vouchers in accordance with relevant requirements and publish the information listed in the filing information table on its website.
（4） If there is a registration change during the validity period of the medical device registration certificate, the registrant shall apply for the registration change to the original registration department. If the original registration certificate was issued according to the original Classification Catalogue of Medical Devices, the remarks column of the registration change documents related to the products in this announcement should indicate the product management category after the implementation of the announcement.
（5） Drug regulatory authorities at all levels should strengthen the promotion and training of the content adjustment of the Classification Catalogue of Medical Devices, and effectively carry out the review, approval, filing, and post market supervision of related products.
This announcement shall come into effect from the date of its publication.
Attachment: 1. Summary of opinions on the adjustment of product management categories in the medical device classification catalog
2. Summary Table of Opinions on Adjusting the Content of the Classification Catalogue of Medical Devices
National Medical Products Administration
December 18, 2020