The newly amended regulations on the supervision and administration of medical devices (order of the State Council No. 739, hereinafter referred to as the new regulations) will come into operation on June 1,2021. The State Food and Drug Administration is preparing and revising supporting regulations, regulatory documents and technical guidelines, which will be issued in accordance with the procedures. In connection with the implementation of the new ordinance, we hereby announce the following: (1) the full implementation of the system of medical device registrants and registrants with effect from 1 June 2021, any enterprise or medical device research and development institution that holds a medical device registration certificate or has filed a Category I medical device shall, in accordance with the new regulations, to fulfill the obligations of medical device registrants and archivists respectively, and to strengthen the quality management of medical devices throughout their life cycle, to be responsible for the safety and effectiveness of medical devices in the whole process of development, production, operation and use. II. With effect from June 1,2021, the regulations on the registration and record-keeping of medical devices shall be promulgated before the implementation of the new regulations, the applicant for registration of medical devices and the filing person shall continue to apply for registration and keep records in accordance with the existing provisions. The requirements for clinical evaluation of medical devices shall be implemented in accordance with Article 3 of this notice. The drug supervision and Administration Department shall carry out the registration and record-keeping related work in accordance with the procedures and time limits currently stipulated. III. The management of clinical evaluation of medical devices
Since June 1,2021, medical device registration applicants, record holders in accordance with the new provisions of the“Regulations” clinical evaluation. Those who meet the conditions of exemption from clinical evaluation stipulated in the new regulations may be exempted from clinical evaluation, and when conducting clinical evaluation, they may be exempted from clinical evaluation on the basis of product characteristics, clinical risks, available clinical data, etc. , through carrying out 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; The available clinical literature and data are insufficient to confirm the safety and effectiveness of medical devices, and clinical trials should be carried out. Prior to the release of the relevant documents for exemption from clinical evaluation, the medical device catalogue for exemption from Clinical Evaluation shall refer to the current medical device catalogue for exemption from clinical trials. 4. On the administration of production license and record-keeping of medical devices, prior to the promulgation and implementation of the relevant provisions of the new regulations on production license and record-keeping, the medical device registrant and the record-keeper shall handle the production license, record and entrust the production in accordance with the existing regulations and normative documents. Management of business license and record keeping of medical devices
A medical device registrant or a record-keeper shall sell the registered or record-keeping medical devices at his residence or production address without the need for business license or record-keeping, but shall meet the prescribed business conditions Where medical devices of the second and third categories are stored or sold in other places, the business license for medical devices shall be obtained or put on record in accordance with the relevant provisions. The State Food and Drug Administration has drawn up a catalogue of Category II medical devices exempt from business registration and is now seeking public comments. After the product catalog is published, execute by directory. (vi) with regard to the investigation and punishment of illegal acts of medical devices, the regulations before the amendments shall apply to those illegal acts of medical devices that occurred before 1 June 2021, however, the new“Regulations” shall apply to those who are not found to be in violation of the law or who are given lesser punishment. The new ordinance shall apply to offences committed after 1 June 2021. Notice is hereby given. State Food and Drug Administration 31 May 2021
