Regarding the Implementation of the Medical Device Production + Operation Supervision and Management Measures, the Official Emphasizes Four Things!

Measures for the Supervision and Administration of Medical Device Production (Order No. 53 of CMSA) (hereinafter referred to as the Production Measures), Measures for the Supervision and Administration of Medical Device Operations (Order No. 54 of the CMSA) (hereinafter referred to as the Operation Measures) have been released and will come into force on May 1, 2022. On March 23, 2022, NMPA issued the Notice of the NMPA on the Implementation of the “Measures for the Supervision and Administration of Medical Device Production and Measures for the Supervision and Administration of Medical Device Operation“, including the following four aspects:

I.Filing of the license for the production and operation of medical devices

Before May 1, 2022, applications for production and operation licenses of medical devices accepted but not yet approved by the pharmaceutical supervisory and administrative department shall, after the implementation of the production measures and Operation measures, for those that meet the conditions, handle and issue licenses for the production and operation of medical devices in accordance with the time limit stipulated in the production measures and Operation measures respectively.

II.On the style and printing of licenses and record certificates

The format and numbering method of the “Medical Device Production License” and “Medical Device Business License” shall be formulated by the NMPC, and the relevant drug supervision and administration departments shall print them according to the regulations.

In order to facilitate medical device production operation activities and facilitate social and corporate queries, the relevant drug supervision and management authorities can provide, according to the corporate needs, the filed credentials of the production of type I medical devices, and the filed credentials of the operation of type II medical devices.

III.About license record change, renewal and reissuance

The medical device production license and medical device business license within the current validity period will continue to be valid.

After the implementation of the Production Measures and the Operation Measures, 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” and  the Operation Measures respectively. The relevant requirements of the Measures and the Operational Measures shall be handled, and the filing number shall remain unchanged.

IV.On 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 NMPA 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.

Since May 1,2022, the Annoucement of NMPA on the Implementation of Relevant Matters of the Measures for the Supervision and Management of Medical Device Production and the Measures for the Supervation and Management of Medical Device Operation (NMPA[2014] No. 143)will be abolished.

Source：NMPA

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