In order to further deepen the reform of the medical device review and approval system, based on the development of the medical device industry and the actual supervision and management of medical devices, in accordance with the “Regulations for the Supervision and Management of Medical Devices”, “Medical Devices Classification Catalog Dynamic Adjustment Work Procedures”, the State Drug Administration has decided to adjust some of the contents of the “Classification Catalog of Medical Devices”. The relevant matters are announced as follows:
Adjustment of 58 classes of medical devices related to the content of the “Medical Device Classification Catalog”, the specific adjustments are shown in the annex.
Implementation Requirements
(I) For the adjustments in the Annex related to 01-01-03 “ultrasonic surgical equipment accessories” in the “ultrasonic cutting and hemostasis head, ultrasonic soft tissue surgical head, ultrasonic suction surgical head” and 01-01-06 “breast rotary excision biopsy system and accessories” which are managed as Class III medical devices, from the date of publication of this announcement, the drug administration department shall, in accordance with the “Medical Device Registration and Accessories”, “breast rotary excision puncture needle and accessories”. Breast rotary excision biopsy system and accessories” in “Breast rotary excision puncture needles and accessories”, since the date of this announcement, the drug supervision and management departments in accordance with the “Medical Device Registration and Filing Management Measures” “On the Announcement of the Requirements for the Registration of Medical Devices and the Format of the Approval Document” and so on. Announcement on the Publication of Requirements for Medical Device Registration and Format of Approval Document”, etc., the drug administration department will accept the application for registration of medical devices according to the adjusted category.
For the announcement has been accepted before the completion of registration approval (including the first registration and continuation of registration) of medical devices, drug supervision and management departments continue to review and approval in accordance with the original acceptance of the category, registration is granted, the issuance of a medical device registration certificate, limited to the validity of the certificate of registration of medical devices for the deadline of December 31, 2025, and in the registration certificate remarks column after the adjustment of the category of product management. For has obtained the registration certificate of Class II medical devices, before December 31, 2025 product registration certificate continues to be valid, the registrant should be involved in accordance with the relevant requirements of the corresponding management category to actively carry out the conversion of the registration certificate, before December 31, 2025 to complete the conversion. Carry out the conversion work during the original medical device registration certificate expires, in the product safety and effective and listed on the premise of no serious adverse events or quality accidents, the registrant can be in accordance with the original management attributes and categories to the original approval department to apply for an extension, to be extended, the validity of the original medical device registration certificate shall not be more than December 31, 2025.
Since January 1, 2026, such products shall not be produced, imported and sold without obtaining the registration certificate for Class III medical devices in accordance with the law. The relevant manufacturers should effectively implement the main responsibility for product quality and safety to ensure the safety and effectiveness of listed products.
(B) for the adjustment of the content of other products, since the date of publication of this announcement, drug supervision and management departments based on the “Registration and Filing of Medical Devices” “on the announcement of the requirements for registration of medical devices to declare the information and approval of the format of the document” “on the filing of Class I medical devices on the announcement of the relevant matters” and so on, in accordance with the adjusted category to accept the application for registration of medical devices or for the record.
For the accepted has not yet completed the registration approval (including the first registration and renewal of registration) of medical devices, drug supervision and management departments continue to review and approval in accordance with the original category of acceptance, registration is granted, the issuance of medical device registration certificate, and in the registration certificate remarks column after the adjustment of the product management category.
For the registered medical devices, its management category from the third class adjusted to the second class, medical device registration certificate in the validity period continues to be valid. If you need to continue, the registrant should be in the medical device registration certificate expires 6 months before the expiration date, in accordance with the category after the change to the appropriate drug supervision and management department to apply for renewal of registration, granted the renewal of registration, in accordance with the adjusted category of product management issued by the medical device registration certificate.
For the registered medical devices, its management category from the second class adjusted to the first class, the medical device registration certificate in the validity period continues to be valid. Before the expiration of the registration certificate, the registrant can apply for the product record to the corresponding department.
Medical device registration certificate within the validity of registration changes, the registrant shall apply to the original registration department to change the registration. If the original registration certificate is issued in accordance with the original “Medical Device Classification Catalog”, this announcement involves a change in the product registration file should be indicated in the remarks column after the implementation of the announcement of the product management category.
(C) drug supervision and management departments at all levels to strengthen the “Medical Device Classification Catalog” content adjustment of the publicity and training, and effectively do a good job related to product review and approval, filing and post-market supervision.
Post time: Aug-24-2023