Aug 18, 2022

China’s National Medical Products Administration (NMPA) has amended guidance on record filing requirements for low-risk Class I medical devices in order to reflect broader updates to medical device and in vitro diagnostic (IVD) regulations, and has also identified relevant standards for China’s Unique Device Identification (UDI) system.

Record filing changes for low-risk medical device registrants

First, the NMPA’s record filing changes under Announcement No. 62 of 2022 (link in Chinese) include the following details that should be of interest to Class I medical device market registrants in China:

  • Simplified filing requirements that no longer include items such as risk analysis reports or clinical evaluation reports;
  • Additional requirements for details including product name and description, intended use and model/specification;
  • Issuance of a device filing number via a “Notification of Filing Number,” which replaces the current Filing Certificate.

The NMPA’s revisions to Class I device record filing rules replaces the regulator’s Announcement No. 26 of 2014.

Standards for UDI identified

Second, the NMPA has compiled its list of relevant standards (link in Chinese) to support UDI of medical devices.

Standards identified by the NMPA include:

  • Basic Requirements for Unique Identification of Medical Devices
  • Database Basic Data Set for Unique Identification of Medical Devices
  • Guidelines for Reporting in the Database of Unique Identification of Medical Devices
  • Basic Terms for the System of Unique Identification of Medical Devices

Updates regarding NMPA UDI requirements and compliance will be provided as Emergo by UL consultants learn them.

Additional Chinese medical device and IVD regulatory resources from Emergo by UL:

  • China NMPA medical device registration and approval consulting
  • Medical device clinical and testing requirements assessment for China
  • Whitepaper: China NMPA medical device registration
  • Webinar: Medical device registration in China

 

Author

  • Stewart Eisenhart

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