China’s Regulatory Pathway for Customized Medical Devices (CMDs)

On 04.07.2019, the China NMPA (National Medical Products Administration) and NHC (National Health Commission) jointly published the Notice (No.53-2019) in relation to the Provisions on the Supervision and Administration of Customized Medical Devices that became effective since 01.01.2020 to provide a regulatory pathway for CMDs to meet the special clinical demands for medical institutions to treat designated patients.

The provisions consist a total of 6 chapters and 35 articles to cover general principles, filing management, design and process, user management, supervision and administration, and supplementary provisions. The registration of CMDs must meet specific requirements including, but not limited to the following:

– A manufacturer and a medical institution are both required to be the filers of the customized medical device
– All CMDs must be originally manufactured and not outsourced to contractors
– Once the number of clinical cases and preliminary studies meet the requirements of pre-market approval, the registration of CMDs should be completed in accordance with the standard administrative measures for the registration of medical devices and IVDs.
– Submission of clinical data that are authentic, accurate, complete, and traceable, as well as meeting ethical standards will be considered as supporting materials during the registration application.