The newly revised ' Regulations on the Supervision and Administration of Medical Devices ' ( State Council Decree No.739, hereinafter referred to as the new ' Regulations ' ) will effect on June 1,2021. The National Drug Administration is organizing the preparation and revision of supporting regulations, normative documents and technical guidelines, which will be published in accordance with the procedures. Announcements on the implementation of the new ' Regulations ' are as follows :
1. On the full implementation of medical device registration, filing system
Starting from June 1, 2021, all enterprises and medical device development institutions holding medical device registration certificates or having handled the filing of Category I medical devices shall, in accordance with the provisions of the new Regulations, fulfill the obligations of medical device registrants and filers respectively, strengthen the quality management of medical devices throughout the life cycle, and assume responsibility for the safety and effectiveness of medical devices in the whole process of research, production, operation and use according to law.
2. On medical device registration, filing management
Since June 1, 2021, before the release and implementation of the relevant provisions on registration and filing of the new 'Regulations', applicants for medical device registration and filers continue to apply for registration and filing in accordance with the current regulations. The requirements for clinical evaluation of medical devices shall be implemented in accordance with Article 3 of this Announcement. The drug supervision and management department carries out registration and filing related work in accordance with the current procedures and time limits.
3. Management of Clinical Evaluation of Medical Devices
From June 1, 2021, medical device registration applicants and filers will conduct clinical evaluations in accordance with the new 'Regulations'. those complying with the provisions of the new ' Regulations ' may be exempted from clinical evaluation ; clinical evaluation can be based on product characteristics, clinical risk, existing clinical data, etc., through clinical trials, or through the same variety of medical devices clinical literature, clinical data analysis and evaluation to prove that medical devices safe and effective ; existing clinical literature, clinical data is not enough to confirm product safety, effective medical devices, should carry out clinical trials. Before the release and implementation of relevant documents exempted from clinical evaluation, the list of medical devices exempted from clinical evaluation is implemented with reference to the current list of medical devices exempted from clinical trials.
4.About medical device production license, filing management
Before the release and implementation of the relevant provisions of the new 'Regulations' supporting production licenses and filing, medical device registrants and filers handle production licenses, filing and commissioned production in accordance with existing regulations and normative documents.
5.On medical device business license, filing management
A medical device registered or registered by a medical device registered or registered person who sells the medical device registered or registered at his residence or production address does not require a medical device business license or registration, but shall comply with the prescribed operating conditions ; if the second and third types of medical devices are stored and sold in other places, the medical device business license or record should be processed in accordance with the provisions.
The State Drug Administration has drafted a catalogue of category II medical equipment products exempted from business registration and is seeking public advice. After the product catalog is released, follow the catalog.
6.The investigation and punishment of medical device illegal behavior
If the illegal behavior of medical devices occurred before June 1, 2021, the “ Regulations ” before revision shall be applied. However, if the new “ Regulations ” deems that it is not illegal or the punishment is light, the new “ Regulations ” shall be applied. The new ' Regulations ' apply where the offence occurred after 1 June 2021.
It is hereby announced.
National Drug Administration
May 31, 2021
Post time: Jun-01-2021