News

Announcement of the State Food and Drug Administration on adjusting part of the contents of the classification catalogue of medical devices (No. 147, 2020)

2021-02-02 11:31:07 vcc 10

In order to further deepen the reform of the review and approval system of medical devices, according to the actual development and supervision of the medical device industry, and in accordance with the relevant requirements of the regulations on the supervision and administration of medical devices, the State Food and Drug Administration decided to adjust some contents of the classification catalog of medical devices. The relevant matters are hereby announced as follows:


1、 Adjust content

The contents of 28 categories of medical devices were adjusted, including 15 categories of medical devices (see Annex 1) and 13 categories of medical devices (see Annex 2).

2、 Implementation requirements

(1) Since the date of this announcement, the drug regulatory department will accept the application for registration and filing of medical devices according to the adjusted categories in accordance with the administrative measures for registration of medical devices, the announcement on the requirements for the registration of medical devices and the format of approval documents, and the announcement on matters related to the filing of class I medical devices.

(2) For the medical devices that have been accepted but have not completed the registration examination and approval (including the first registration and continued registration), the drug regulatory department shall continue to review and approve according to the original acceptance category. If the registration is approved, the medical device registration certificate shall be issued, and the adjusted product management category shall be indicated in the remarks column of the registration certificate.

(3) For registered medical devices whose management category is adjusted from the third category to the second category, the medical device registration certificate shall remain valid within the period of validity. In case of renewal, 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 medical device registration certificate. If the renewal of registration is approved, the medical device registration certificate shall be issued according to the adjusted product management category.

For registered medical devices whose management category is adjusted from the second category to the first category, the medical device registration certificate shall continue to be valid within the period of validity. Before the expiration of the registration certificate, the registrant may apply to the corresponding drug regulatory department for product filing. If the filing materials meet the requirements, the drug regulatory department shall make the Filing Certificate according to the relevant requirements and publish the information in the filing information form on its website.

(4) In case of registration change within the validity period of the medical device registration certificate, the registrant shall apply to the original registration department for registration change. If the original registration certificate is issued according to the original medical device classification catalog, the product management category after the implementation of the announcement shall be indicated in the remarks column of the registration change document of the products involved in this announcement.

(5) Drug supervision and administration departments at all levels should strengthen the publicity and implementation training of the content adjustment of medical device classification catalog, and earnestly do a good job in the review, approval, filing, and post-marketing supervision of relevant products.

This announcement shall come into effect as of the date of promulgation.

Appendix: 1. Summary of opinions on adjustment of product management category in medical device classification catalog

                 2. Summary of opinions on content adjustment of medical device classification catalog

                                                                                                                                                         State Food and Drug Administration


                                                                                                                                                                                  December 18, 2020

Appendix 1.doc of announcement No.147 of State Drug Administration in 2020

Appendix 2.doc of announcement No.147 of State Drug Administration in 2020