"Measures for the Supervision and Administration of Medical Device Production" (Order No. 53 of the State Administration for Market Regulation) (hereinafter referred to as the "Production Measures") "Measures for the Supervision and Administration of Medical Device Operation" (Order No. 54 of the State Administration for Market Regulation) (hereinafter referred to as the "Measures for the Supervision and Administration of Medical Devices" (Order No. 54 of the State Administration for Market Regulation) Operational Measures") has been issued and will come into force on May 1, 2022. The relevant matters are hereby announced as follows:

1. Effectively strengthen the implementation of publicity and training

The drug supervision and administration departments at all levels should strengthen the study, publicity and training of the "Production Measures" and "Operation Measures", have a deep understanding and accurate grasp, and conscientiously implement them in combination with local actual conditions, and effectively implement the responsibilities of medical device quality and safety supervision.

Enterprises engaged in the production and operation of medical devices should strengthen the study and training of medical device laws and regulations, conscientiously implement the requirements of laws and regulations, and earnestly fulfill the responsibilities of medical device product quality and safety management.

2. Filing of licenses for the production and operation of medical devices

From May 1, 2022, new applications for engaging in medical device production and business activities shall be licensed or filed in accordance with the relevant provisions of the "Production Measures" and "Operation Measures".

Before May 1, 2022, the medical device production and business license applications that have been accepted by the drug regulatory department but have not yet been approved, after the implementation of the "Production Measures" and "Operation Measures", for those that meet the conditions, according to the "Production Measures" " The production and business licenses for medical devices shall be processed and issued within the time limit stipulated in the Operational Measures.

3. The format and printing of licenses and filing certificates

The format and numbering method of the "Medical Device Production License" and "Medical Device Business License" are uniformly formulated by the State Drug Administration, and the relevant drug supervision and administration departments will print them according to the regulations.

In order to facilitate the production and operation of medical devices, and to facilitate the inquiry of the society and enterprises, the relevant drug supervision and administration departments may provide the first-class medical device production record certificate and the second-class medical device operation record certificate according to the needs of the enterprise.

4. About the change, renewal and reissuance of license filing

The existing medical device production license and medical device business license within the validity period will continue to be valid. After the implementation of the "Production Measures" and "Operation Measures", if the medical device production license and medical device business license need to be changed, renewed, or reissued, they shall be handled in accordance with the relevant provisions of the "Production Measures" and "Operation Measures" respectively. The validity period of the changed or reissued license remains unchanged.

The existing Class I medical device production record certificate and Class II medical device business record certificate continue to be valid. After the implementation of the "Production Measures" and "Operation Measures", if it is necessary to change or reissue the production recordation certificates for the first-class medical devices and the second-class medical device business recordation certificates other than those exempted from the operation recordation, they shall be issued in accordance with the "Production Measures" respectively. The relevant requirements of the Measures and the Operational Measures shall be handled, and the filing number shall remain unchanged.

5. About the application of license filing information management

Drug supervision and administration departments at all levels shall disclose the information of medical device production and business license filing in accordance with the law to facilitate public inquiries, and upload them to the data sharing platform of the State Food and Drug Administration in a timely manner to realize the data sharing of the national drug supervision system. Drug regulatory departments at all levels shall actively promote the issuance and application of electronic licenses for medical device production and business licenses in accordance with the national electronic license work requirements and relevant standards.

From May 1, 2022, the "Notice of the China Food and Drug Administration on the Implementation of the Measures for the Supervision and Administration of Medical Device Production" and the "Measures for the Supervision and Administration of Medical Device Operation" (Food and Drug Administration [2014] No. 143) be repealed.

  announce.

Attachment: 1. Application form and license format for medical device production license

2. Type I medical device production record form and record certificate format

3. Medical device business license application form and license format

4. Type II medical device business record form and record certificate format

5. Instructions for filling in

State Food and Drug Administration

March 11, 2022

State Drug AdministrationAnnouncement No.18 of 2022 Annex 1.doc

State Drug AdministrationAnnouncement No. 18 of 2022 Annex 2.doc

State Drug AdministrationAnnouncement No. 18 of 2022 Annex 3.doc

State Drug AdministrationAnnouncement No. 18 of 2022 Annex 4.doc

State Drug AdministrationAnnouncement No. 18 of 2022 Annex 5.doc