The Revision of Class III Medical Devices that Need to be Approved for Clinical Trial ( revised in 2020)

2020, September 14th, in order to further strengthening the management of medical instruments clinical trial in the process of maintenance of medical instrument clinical trial subjects rights and interests, promote the regulation of scientific research achievements, improve the efficiency of examination and approval, and to speed up the market, the NMPA organized the revision of the opinions on 'deepening the Reform of the Review and Approval System to Encourage innovation of Drugs and Medical Devices'. According to 'the regulations on the supervision and administration of medical devices', the NMPA organized the revision of the list of category III medical devices subject to clinical trial approval, which is hereby promulgated and shall come into force as of the date of promulgation.

The circular on the publication of the Catalogue of Category III Medical Devices subject to Clinical Trial Approval (CFDA circular No. 14 of 2014) shall be repealed simultaneously.