Medical Devices Now Subject to Registrant and Filing Administration

Following the implementation of the revised Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 739 [2021]) on 1 June, the National Medical Products Administration (NMPA) is revising the relevant rules and regulations, normative documents and technical guidelines, which will be released in due course. In this regard, the NMPA issued an announcement that the new regulations cover the full implementation of the system of registrants and filing parties of medical devices, the administration of registration and record-filing of medical devices, the administration of clinical assessment of medical devices, the administration of medical device production licensing and record-filing, and the investigation and punishment of illegal acts involving medical devices.

Full details can be found in an NMPA announcement issued on 31 May.

Source: National Medical Products Administration