In order to further deepen the reform of review and approval system for medical devices, based on the actual development of the medical device industry and supervision and in accordance with the relevant requirements of the Regulation on the Supervision and Administration of Medical Devices, the National Medical Products Administration has decided to adjust some of the contents of the Category of Medical Device Classification. The relevant matters are hereby announced as follows:
I. Adjustments
The contents of the Category of Medical Device Classification 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).
II. Implementation requirements
(I) Since the date of this announcement, the food and drug administration shall accept medical device registration and recording applications according to the adjusted categories in compliance with the Administrative Measures for Medical Device Registration, Announcement on Publication of Medical Device Registration Requirements and Approval Document Formats, and Announcement for Matters on Class I Medical Device Notification.
(II) For accepted medical devices that have not been registered (including initial registration and renewal registration), the food and drug administration will continue to review and approve such devices according to the original acceptance category. If a device is approved to be registered, the medical device registration certificate shall be issued and the adjusted product management category shall be given in the registration certificate remarks column.
(III) For registered medical devices, the management category shall be adjusted from Class III to Class II, and the medical device registration certificate shall remain valid during the validity period. If renewal is required, the registrant shall apply for renewal of the registration with the corresponding food and drug administration 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, the management category shall be adjusted from Class II to Class I, and the medical device registration certificate shall remain valid during the validity period. Before the expiration of the registration certificate, the registrant may apply to a corresponding food and drug administration for product filing. If the filing materials meet the requirements, the food and drug administration shall prepare a recording evidence in accordance with relevant requirements and publish relevant information in the filing information form on its website.
(IV.) In case of 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 Category of Medical Device Classification, product management category shall be filled in the remarks column of the product registration change documents involved in this announcement.
(V.) Drug supervision and administration departments at all levels should strengthen publicity efforts regarding adjustments to the content of Category of Medical Device Classification, and step-up review and approval, recording and post-marketing supervision of related products.
The Announcement shall come into effect starting from the day of release.
Attachment:
1. Summary Table of Comments on Adjustments to the Content of Product Management Category in the Category of Medical Device Classification
2. Summary Table of Comments on Adjustments to the Category of Medical Device Classification
I. Adjustments
The contents of the Category of Medical Device Classification 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).
II. Implementation requirements
(I) Since the date of this announcement, the food and drug administration shall accept medical device registration and recording applications according to the adjusted categories in compliance with the Administrative Measures for Medical Device Registration, Announcement on Publication of Medical Device Registration Requirements and Approval Document Formats, and Announcement for Matters on Class I Medical Device Notification.
(II) For accepted medical devices that have not been registered (including initial registration and renewal registration), the food and drug administration will continue to review and approve such devices according to the original acceptance category. If a device is approved to be registered, the medical device registration certificate shall be issued and the adjusted product management category shall be given in the registration certificate remarks column.
(III) For registered medical devices, the management category shall be adjusted from Class III to Class II, and the medical device registration certificate shall remain valid during the validity period. If renewal is required, the registrant shall apply for renewal of the registration with the corresponding food and drug administration 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, the management category shall be adjusted from Class II to Class I, and the medical device registration certificate shall remain valid during the validity period. Before the expiration of the registration certificate, the registrant may apply to a corresponding food and drug administration for product filing. If the filing materials meet the requirements, the food and drug administration shall prepare a recording evidence in accordance with relevant requirements and publish relevant information in the filing information form on its website.
(IV.) In case of 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 Category of Medical Device Classification, product management category shall be filled in the remarks column of the product registration change documents involved in this announcement.
(V.) Drug supervision and administration departments at all levels should strengthen publicity efforts regarding adjustments to the content of Category of Medical Device Classification, and step-up review and approval, recording and post-marketing supervision of related products.
The Announcement shall come into effect starting from the day of release.
Attachment:
1. Summary Table of Comments on Adjustments to the Content of Product Management Category in the Category of Medical Device Classification
2. Summary Table of Comments on Adjustments to the Category of Medical Device Classification
National Medical Products Administration
December 18, 2020
December 18, 2020