Implementation of the "Regulations on the Supervision and Administration of Medical Devices" related matters

The newly revised "Regulations on the Supervision and Administration of Medical Devices" (Order No.
739 of the State Council, hereinafter referred to as the new "Regulations") will be implemented on June 1, 2021.
The State Food and Drug Administration is organizing the formulation and revision of supporting regulations, normative documents and technical guidelines, etc.
, which will be successively issued in accordance with the procedures.
The following is an announcement regarding the implementation of the new "Regulations" related 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 already filed for Class I medical devices shall, in accordance with the provisions of the new "Regulations," perform the medical device registrant and recorder respectively.
the obligation, to strengthen the medical device lifecycle quality management, development, production, operation, use the whole process of Chinese medicine safety equipment therapy, efficacy legally responsible.

 

2.
Regarding medical device registration and filing management

 

Starting from June 1, 2021, before the relevant provisions of the new "Regulations" supporting registration and filing 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.
The requirements for clinical evaluation of medical devices shall be implemented in accordance with Article 3 of this Announcement.
The drug supervision and administration department shall carry out registration and filing related work in accordance with the procedures and time limits currently prescribed.

 

　　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".
Those who comply with the exemption from clinical evaluation as stipulated in the new "Regulations" can be exempted from clinical evaluation; for clinical evaluation, clinical trials can be carried out based on product characteristics, clinical risks, and existing clinical data, or through clinical trials of the same type of medical treatment.
The clinical documentation and clinical data of the device are analyzed and evaluated to prove that the medical device is safe and effective; the existing clinical documentation and clinical data are insufficient to confirm the product safety and effectiveness of medical devices, and clinical trials should be carried out.
Prior to the release and implementation of relevant documents exempted from clinical evaluation, the list of medical devices exempted from clinical evaluation shall be implemented with reference to the current catalog of medical devices exempted from clinical trials.

 

　　4.
Regarding the production license and record management of medical devices

 

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

 

　　V.
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.
After the product catalog is released, follow the catalog.

 

　　VI.
Investigation and handling of medical device violations

 

　　Medical device violations occurred before June 1, 2021, the pre-revised "Regulations" apply, but according to the new "Regulations" deemed not illegal or the punishment is lighter, the new "Regulations" apply.
If the violation occurs after June 1, 2021, the new "Regulations" shall apply.

 

　　Special announcement.

 

　　State Food and Drug Administration

 

　　May 31, 2021

　　The newly revised "Regulations on the Supervision and Administration of Medical Devices" (Order No.
739 of the State Council, hereinafter referred to as the new "Regulations") will be implemented on June 1, 2021.
The State Food and Drug Administration is organizing the formulation and revision of supporting regulations, normative documents and technical guidelines, etc.
, which will be successively issued in accordance with the procedures.
The following is an announcement regarding the implementation of the new "Regulations" related 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 already filed for Class I medical devices shall, in accordance with the provisions of the new "Regulations," perform the medical device registrant and recorder respectively.
the obligation, to strengthen the medical device lifecycle quality management, development, production, operation, use the whole process of Chinese medicine safety equipment therapy, efficacy legally responsible.

 

　　2.
Regarding medical device registration and filing management

 

　　Starting from June 1, 2021, before the relevant provisions of the new "Regulations" supporting registration and filing 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.
The requirements for clinical evaluation of medical devices shall be implemented in accordance with Article 3 of this Announcement.
The drug supervision and administration department shall carry out registration and filing related work in accordance with the procedures and time limits currently prescribed.

 

　　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".
Those who comply with the exemption from clinical evaluation as stipulated in the new "Regulations" can be exempted from clinical evaluation; for clinical evaluation, clinical trials can be carried out based on product characteristics, clinical risks, and existing clinical data, or through clinical trials of the same type of medical treatment.
The clinical documentation and clinical data of the device are analyzed and evaluated to prove that the medical device is safe and effective; the existing clinical documentation and clinical data are insufficient to confirm the product safety and effectiveness of medical devices, and clinical trials should be carried out.
Prior to the release and implementation of relevant documents exempted from clinical evaluation, the list of medical devices exempted from clinical evaluation shall be implemented with reference to the current catalog of medical devices exempted from clinical trials.

 

　　4.
Regarding the production license and record management of medical devices

 

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

 

　　V.
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.
After the product catalog is released, follow the catalog.

 

　　VI.
Investigation and handling of medical device violations

 

　　Medical device violations occurred before June 1, 2021, the pre-revised "Regulations" apply, but according to the new "Regulations" deemed not illegal or the punishment is lighter, the new "Regulations" apply.
If the violation occurs after June 1, 2021, the new "Regulations" shall apply.

 

　　Special announcement.

 

　　State Food and Drug Administration

 

　　May 31, 2021