Announcement of the National Food and Drug Administration on Adjusting Part of the "Medical Device Classification Catalogue"
In order to further deepen the reform of the medical device review and approval system, in accordance with 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 National Food and Drug Administration has decided to review the "Medical Devices Classification Catalog" will be adjusted. The relevant matters are now announced as follows:
1. Adjust the content
The contents of the "Medical Device Classification Catalogue" of 28 types of medical devices were adjusted. Among them, the management categories of 15 types of medical devices were adjusted (see Annex 1), and the contents of the 13 types of medical device catalogs were adjusted (see Annex 2).
2. Implementation requirements
(1) Since the date of this announcement, the drug supervision and administration department shall comply with the "Administrative Measures for Medical Device Registration", "Announcement on Publication of Medical Device Registration Declaration Document Requirements and Approval Document Formats" and "About Articles. Class I Medical Devices Announcement on Filing Related Matters, etc., according to the adjusted categories Accept medical device registration and filing applications.
(2) For medical devices that have been accepted and have not yet completed the registration approval (including the first registration and renewal of registration), the drug regulatory department continues to review and approve according to the original acceptance category, and if the registration is approved, the medical device registration certificate will be issued and registered The certificate remarks column indicates the adjusted product management category.
(3) For registered medical devices, if the management category is adjusted from the third category to the second category, the medical device registration certificate will continue to be valid during the validity period. If renewal is required, the registrant shall, 6 months before the expiration of the medical device registration certificate, apply to the corresponding drug regulatory authority for renewal of the registration according to the changed category. If the renewal is approved, the medical device shall be issued according to the adjusted product management category. Registration certificate.
For registered medical devices, if the management category is adjusted from the second category to the first category, the medical device registration certificate will continue to be valid during the validity period. Before the expiration of the registration certificate, the registrant may apply to the corresponding drug regulatory authority for product filing. If the filing materials meet the requirements, the drug regulatory agency shall prepare a filing voucher in accordance with relevant requirements and publish the information published in the filing information form on its website.
(4) If there is a registration change within the validity period of the medical device registration certificate, the registrant shall apply to the original registration department for the registration change. If the original registration certificate was issued in accordance with the original "Medical Device Classification Catalogue", the remarks column of the product registration change documents involved in this announcement should indicate the product management category after the announcement.
(5) Drug supervision and administration departments at all levels should strengthen the publicity and implementation training of the content adjustment of the "Medical Device Classification Catalogue", and earnestly do a good job in the review and approval, filing and post-marketing supervision of related products.
This announcement will be implemented from the date of release.
Attachment: 1. Summary table of adjustment opinions on product management category of medical device classification catalog
2. Summary table of comments on the content adjustment of the medical device classification catalog
National Drug Administration
December 18, 2020