In accordance with the Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 680 in 2017): the State classifies and regulates medical devices on the basis of level of risk.

Class I medical devices are those at low level of risk, and their safety and effectiveness can be ensured through routine regulation. Class I medical devices shall be regulated through recording: 1) For a domestic Class I medical device, the domestic manufacturer shall submit recording application dossiers to the Medical Products Administration authority at the level of city with sub-districts where the manufacturer is located; 2) For an imported Class I medical device, the overseas manufacturer shall entrust an Agent in China to submit the recording application dossiers to NMPA.

Hongkong and Macao’s medical device registration shall refer to the regulation of