Registration of Medical Devices: Revised Criteria Adopted by SAMR

The 11th Bureau Meeting of the State Administration of Market Supervision and Administration in 2021, deliberated upon and adopted the criteria for the administration of registration of medical devices, and in vitro diagnostic reagents, effective October 1, 2021.

The revised criteria for the registration of medical devices total 10 chapters and 124 stipulations, whilst that of the in vitro diagnostic reagents totals 10 chapters and 125 stipulations. It is highlighted that the implementation of the reform requirements, including simplifying the overseas listing documents, inspection reports and other registration and filing information requirements, especially for innovative medical devices not currently registered overseas, no longer need to submit overseas registration documents, thus encouraging an expedited innovative devices registration pathway for the Chinese market.