The State Food and Drug Administration issued an announcement on the implementation of the "Regulations on the Supervision and Administration of Medical Devices" and other matters

On May 31, the State Food and Drug Administration issued an announcement on the implementation of the "Regulations on the Supervision and Administration of Medical Devices" and other matters
.

1.
Regarding the full implementation of the medical device registrant and filing system

Starting from June 1, 2021, all enterprises and medical device research and development institutions that hold a medical device registration certificate or have filed for Class I medical devices shall, in accordance with the new "Regulations," perform the medical device registrant and recorder respectively The obligation to strengthen the quality management of medical devices throughout the life cycle, and to take responsibility for the safety and effectiveness of medical devices in the entire process of development, production, operation, and use in accordance with the law
.

2.
Regarding medical device registration and filing management

Starting from June 1, 2021, before the relevant regulations for registration and filing in the new "Regulations" are issued and implemented, medical device registration applicants and filing persons will continue to apply for registration and filing in accordance with the current regulations
.

3.
About the management of clinical evaluation of medical devices

Starting from June 1, 2021, medical device registration applicants and recorders will carry out clinical evaluations in accordance with the new "Regulations"
.

4.
Regarding medical device production license and filing management

       Before the release and implementation of relevant regulations on production licenses and filings supporting the new "Regulations," medical device registrants and filing parties handle production licenses, filings, and entrusted production in accordance with existing regulations and normative documents
.

       5.
Regarding medical device business license and filing management

       Medical device registrants and recorders sell their registered and filed medical devices at their residence or production address.
They do not need to apply for a medical device business license or record, but they should meet the prescribed operating conditions; store and sell the second and third categories in other places For medical devices, medical device business licenses or filings shall be handled in accordance with regulations
.

       The State Food and Drug Administration has drafted a catalog of the second-class medical device products that are exempt from operation and filing, and is currently seeking public opinions
.

       VI.
Investigation and handling of medical device violations

       For medical device violations that occurred before June 1, 2021, the pre-revised "Regulations" shall apply, but if the new "Regulations" are deemed not illegal or the penalty is lighter, the new "Regulations" shall apply
.

       Hereby announce