In order to further deepen the reform of the medical device review and approval system, based on 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” and the “Dynamic Adjustment Work Procedures for the Classification of Medical Devices”, the State Food and Drug Administration has decided to implement the “Medical Some content of the Device Classification Catalogue has been adjusted. The relevant matters are hereby announced as follows:
1. Adjust the content
The 58 types of medical devices involved in the “Medical Device Classification Catalogue” are adjusted, and the specific adjustment content is shown in the attachment.
2. Implementation requirements
(1) Regarding the “ultrasonic cutting hemostatic blade, ultrasonic soft tissue surgical blade, ultrasonic suction surgical blade” and 01 “Ultrasonic Surgical Equipment Accessories” that are managed as the third category of medical devices in the 01-01-03 “Ultrasonic Surgical Equipment Accessories” and 01 -01-06 “Breast rotary biopsy system and accessories” includes “breast rotary biopsy needles and accessories”. The Announcement on the Requirements for Application Documents for Device Registration and the Format of Approval Documents, etc., accepts applications for medical device registration according to the adjusted categories.
For medical devices that have been accepted for registration and approval (including initial registration and renewal registration) before the date of announcement, the drug regulatory department will continue to review and approve according to the original acceptance category. The deadline for validity of the certificate is December 31, 2025, and the adjusted product management category shall be indicated in the remarks column of the registration certificate. For those who have obtained a Class II medical device registration certificate, the product registration certificate will continue to be valid before December 31, 2025, and the registrants involved should actively carry out the registration certificate conversion work in accordance with the relevant requirements of the corresponding management category. Complete the conversion. If the original medical device registration certificate expires during the conversion work, on the premise that the product is safe and effective and no serious adverse events or quality accidents have occurred after listing, the registrant can apply for an extension to the original approval department according to the original management attributes and categories, and the extension will be granted. If the original medical device registration certificate is valid, it shall not exceed December 31, 2025. the
Starting from January 1, 2026, such products shall not be produced, imported and sold without obtaining a registration certificate for Class III medical devices in accordance with the law. Relevant production enterprises should effectively implement the main responsibility for product quality and safety to ensure the safety and effectiveness of marketed products.
(2) For other products whose content has been adjusted, from the date of this announcement, the drug regulatory department shall, in accordance with the “Measures for the Administration of Registration and Filing of Medical Devices” “Announcement on Publishing the Requirements for Application Materials for Medical Device Registration and the Format of Approval Documents” ” “Announcement on Matters Concerning the Filing of Class I Medical Devices”, etc., accepts applications for medical device registration or handles filings according to the adjusted category.
For medical devices that have been accepted for registration and approval (including initial registration and renewal registration), the drug regulatory department will continue to review and approve according to the original acceptance category. If the registration is approved, a medical device registration certificate will be issued, and it will be indicated in the remarks column of the registration certificate. Adjusted product management categories.
For registered medical devices whose management category is adjusted from the third category to the second category, the medical device registration certificate will continue to be valid within the validity period. If renewal is required, the registrant shall apply to the corresponding drug supervision and management department for registration renewal according to the changed category before the expiration of the medical device registration certificate 6 months, and if the renewal registration is approved, the medical device shall be issued according to the adjusted product management category registration certificate.
For a registered medical device whose management category is adjusted from the second category to the first category, the medical device registration certificate will continue to be valid within the validity period. Before the registration certificate expires, the registrant can go through the product filing process with the corresponding department.
If a registration change occurs within the validity period of the medical device registration certificate, the registrant shall apply to the original registration department for a change of registration. If the original registration certificate was issued in accordance with the original “Medical Device Classification Catalog”, the product management category after the implementation of the announcement should be indicated in the remarks column of the change registration document involving products in this announcement.
(3) Drug regulatory departments at all levels should strengthen the publicity and implementation training of the content adjustment of the “Medical Device Classification Catalog”, and effectively do a good job in the review and approval, filing and post-market supervision of related products.