To advance the ongoing reform of the medical device evaluation and approval system, the National Medical Products Administration has decided to amend certain sections of the Classification Catalogue of Medical Devices. This decision is based on the evolving needs and regulatory landscape of the medical device industry, as well as in alignment with the Regulations on the Supervision and Administration of Medical Devices and the Work Procedure for Dynamic Adjustment of the Classification Catalogue of Medical Devices. Herein, we announce the pertinent details as follows:

1. Adjusting content

　　Adjustments will be made to the content of the Medical Device Classification Catalogue for 58 categories of medical devices. Please refer to the attachment for specific adjustments.

2. Implementation requirements

（1） For the "ultrasonic cutting hemostatic scalpel head, ultrasonic soft tissue scalpel head, ultrasonic suction scalpel head" and the "breast chamber rotary cutting puncture needle and accessories" in 01-01-03 "Ultrasonic surgical equipment accessories" as the third category of medical device management involved in the adjustment in the annex, the drug regulatory department will accept the medical device registration application according to the adjusted category in accordance with the "Administrative Measures for Medical Device Registration and Filing", "Notice on Publishing the Medical Device Registration Application Data Requirements and Approval Document Format", etc.

For medical devices that have been accepted but have not yet completed registration approval (including initial registration and continued registration) before the announcement date, the drug regulatory department will continue to review and approve them according to the original acceptance category. If registration is allowed, a medical device registration certificate will be issued, with a limited expiration date of December 31, 2025, and the adjusted product management category 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 shall remain valid before December 31, 2025. The registrants involved shall actively carry out registration certificate conversion work in accordance with the relevant requirements of the corresponding management category and complete the conversion before December 31, 2025. If the original medical device registration certificate expires during the conversion process, and the product is safe and effective without serious adverse events or quality accidents after being launched, the registrant may apply for an extension to the original approval department according to the original management attributes and categories. If the extension is granted, the validity period of the original medical device registration certificate shall not exceed December 31, 2025.

Starting from January 1, 2026, this type of product shall not be produced, imported, or sold without obtaining a Class III medical device registration certificate in accordance with the law. Relevant production enterprises should effectively implement the main responsibility for product quality and safety, ensuring the safety and effectiveness of listed products.

（2） For other products with adjusted content, starting from the date of this announcement, the drug regulatory department shall accept medical device registration applications or handle registration procedures according to the adjusted categories in accordance with the "Measures for the Administration of Medical Device Registration and Filing", "Announcement on the Requirements for Publishing Medical Device Registration Application Materials and Approval Document Formats", and "Announcement on Matters Related to Class I Medical Device Filing".

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

For registered medical devices, if their management category is adjusted from Class III to Class II, the medical device registration certificate will continue to be valid during its validity period. If it is necessary to renew, 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 validity period of the medical device registration certificate. If the renewal is allowed, a medical device registration certificate shall be issued according to the adjusted product management category.

For registered medical devices, if their management category is adjusted from Class II to Class I, the medical device registration certificate will continue to be valid during its validity period. Before the registration certificate expires, the registrant can apply for product registration with the corresponding department.

If there is a registration change during the validity period of the medical device registration certificate, the registrant shall apply to the original registration department for the change of registration. If the original registration certificate was issued according to the original Classification Catalogue of Medical Devices, the remarks column of the registration document for product changes related to this announcement should indicate the product management category after the implementation of the announcement.

（3） Drug regulatory authorities at all levels should strengthen the promotion and training of the content adjustment of the Classification Catalogue of Medical Devices, and effectively carry out the review, approval, filing, and post market supervision of related products.