China – NMPA publishes revised Chinese medical device regulations

China’s National Medical Products Administration (NMPA) has published (links in Chinese) the revised Regulations on the Supervision and Administration of Medical Devices, which introduces changes to the existing Order No. 650. The updated regulatory framework is slated to take effect on June 1, 2021.

When the draft version of this regulatory update was published in June 2018, we reported that the changes were intended to streamline Chinese market access for foreign manufacturers, crack down on non-compliance, and establish a unique device identification (UDI) system for medical devices. Since that time, new UDI requirements have been separately announced by the NMPA; their rollout was subsequently postponed until the beginning of this year in response to the COVID-19 pandemic…