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Announcement of NMPA on Adjusting Part of the Medical Device Catalog (2020 No. 147)

To further deepen the reform of the medical device review and approval system, NMPA has decided to adjust part of the Medical Device Catalog in accordance with the development status and tcal device industry, as well as the relevant requirements of the Regulations. Following are the announcements pertaining to the revision:he regulatory situation of the medi

I Contents Adjusted

Adjust the content of the Medical Device Catalog for 28 categories of medical devices, including 15 medical device management categories (as shown in Appendix 1) and the catalog of 13 medical device categories (as shown in Appendix 2).

II Requirements for Implementation 

1. From the date of publication of this announcement, the drug regulatory authorities shall use the adjusted catalog to review medical device registration and recording applications in accordance with the relevant regulations such as the Administrative Measures for Medical Device Registration, the Announcement on Publishing the Requirements for Medical Device Registration Application and the Format of Approval and Certification Documents and the Announcement Pertaining to the Recording  of Class I Medical Devices.

2. For medical device applications that have been accepted but have not completed registration approval (including initial registration and renewal registration), the drug regulatory authorities shall continue to use the original category to review and approve the application, and shall issue a medical device registration certificate and indicate the adjusted product management category at the remarks column of the registration certificate if the registration is approved,.

3. If the management category of a registered medical device is adjusted from Class III to Class II, the medical device registration certificate will remain valid within the validity period. If a renewal is required, the registrant shall apply with the relevant drug regulatory authority for renewal of registration according to the changed category 6 months before the expiration of the medical device registration certificate. A medical device registration certificate shall be issued according to the adjusted product management category if the application for renewal of registration is approved. 

If the management category of a registered medical device is adjusted from Class II to Class I, the medical device registration certificate will remain valid within the validity period. Before the registration certificate expires, the registrant can apply to the relevant drug regulatory authority for product recording. If the recording materials meet the requirements, the drug regulatory authority shall make a recording certificate in accordance with the relevant requirements, and publish the information in the recording information form on its website.

4. In case of a registration change within the validity period of the medical device registration certificate, the registrant shall apply with the original registration department for the registration change. If the original registration certificate is issued in accordance with the original Medical Device 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 product involved in this announcement.

5. Drug regulatory departments at all levels should strengthen the publicity and training of the content adjustment of the Medical Device Catalog and effectively carry out review and approval, recording and post-marketing supervision of related products. 

This announcement comes into effect on the day of the publication.

Appendix:

1. Summary of Adjustment Opinions on Product Management Category of Medical Device Catalog

2. Summary of Content Adjustment Opinions on Medical Device Catalogue 

NMPA 

December 18, 2020

【Source: State Food and Drug Administration】