According to the relevant provisions of the “Regulation on the Supervision and Administration of Medical Devices”, “Measures for the Administration of Registration and Recordation of Medical Devices” and the mandatory standards issued by the Center for Medical Device Standards Management of NMPA, the Center for Medical Device Evaluation (CMDE) issued the “List of Mandatory Standards Applicable to Medical Devices” for applicants of medical devices to determine the mandatory standards, which apply to a specific product. That is, in order to clarify the applicable conditions of mandatory standards for the respective medical devices.

Attachment:

1. 1. List of Mandatory Standards Applicable to Medical Devices
2. 2. Instructions for the List of Mandatory Standards Applicable to Medical Devices

 

 

Reference:
●  NMPA’s Announcement on Publishing the List of Mandatory Standards Applicable to Medical Device (No. 42 of 2022)