In order to further deepen the reform of the medical device review and approval system, based on the actual development and regulatory work 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 “Working Procedures for Dynamic Adjustment of the Medical Device Classification Catalog”, the State Food and Drug Administration decided to adjust some contents of the “Medical Device Classification Catalog”. The relevant matters are now announced as follows:
1. Adjust the content
The content of the “Medical Device Classification Catalog” involved in 58 categories of medical devices has been adjusted. Please see the attachment for the specific adjustment content.
2. Implementation requirements
(1) For the “ultrasonic cutting and hemostatic blades, ultrasonic soft tissue surgical blades, and ultrasonic suction surgical blades” that are managed as third-class medical devices in 01-01-03 “Ultrasonic Surgical Equipment Accessories” in the attachments and “Breast Rotary Incision Biopsy Systems and Accessories” in 01-01-06 “Breast rotation puncture needles and accessories”. From the date of this announcement, the drug regulatory department will accept medical device registration applications according to the adjusted categories in accordance with the “Medical Device Registration and Filing Management Measures” and “Announcement on the Release of Medical Device Registration Application Document Requirements and Approval Document Format”, etc.
For medical devices that have been accepted for registration review and approval before the announcement date (including initial registration and registration renewal), the drug regulatory department will continue to review and approve them according to the original acceptance category. If registration is approved, a medical device registration certificate will be issued, and the expiration date of the medical device registration certificate will be limited to December 31, 2025, and the adjusted product management category will be noted 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. The registrant involved should actively carry out the conversion of the registration certificate 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, provided that the product is safe and effective and no serious adverse events or quality incidents occur after listing, the registrant can submit an extension application to the original approval department based on the original management attributes and categories. If extended, the validity period of the original medical device registration certificate shall not exceed December 31, 2025.
Starting from January 1, 2026, this type of products 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 responsibilities for product quality and safety to ensure the safety and effectiveness of marketed products.
(2) For other products with adjusted content, from the date of this announcement, the drug regulatory department will accept medical device registration applications or handle filing according to the adjusted categories in accordance with the “Measures for the Administration of Medical Device Registration and Filing”, “Announcement on the Release of Medical Device Registration Application Document Requirements and Approval Document Format”, “Announcement on Matters Related to the Registration of Class I Medical Devices”, etc.
For medical devices that have been accepted but have not yet completed registration review and approval (including initial registration and registration renewal), the drug regulatory department will continue to review and approve them according to the original acceptance category. If registration is approved, a medical device registration certificate will be issued, and the adjusted product management category will be noted in the remarks column of the registration certificate.
For registered medical devices whose management category is adjusted from Category III to Category II, the medical device registration certificate will continue to be valid within the validity period. If extension is required, the registrant should apply to the corresponding drug regulatory department for renewal of registration according to the changed category 6 months before the expiration of the medical device registration certificate. If the registration extension is approved, the medical device registration certificate will be issued according to the adjusted product management category.
For registered medical devices whose management category is adjusted from Category 2 to Category 1, the medical device registration certificate will continue to be valid within the validity period. Before the registration certificate expires, the registrant can apply for product registration with the corresponding department.
If a registration change occurs during the validity period of the medical device registration certificate, the registrant shall apply to the original registration department for registration change. 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 changed registration document for the products involved in this announcement.
(3) Drug regulatory authorities at all levels should strengthen publicity and training on the content adjustment of the “Medical Device Classification Catalog” and effectively conduct relevant product review and approval, filing and post-market supervision.
View the original text and attachments: http://www.cqn.com.cn/zj/content/2023-08/17/content_8970618.htm
