Drug Administration issued medical device clinical trial design guidelines
January 9 In order to implement the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Innovation of Medical Device Innovation to Promote the Reform of the Examination and Approval System for Examination and Approval (Office Word [2017] No. 42), the registration of medical device products To further improve the quality of registration examination and encourage innovation in medical device research and development. The State Food and Drug Administration has formulated the guidelines for the design of clinical trial of medical devices (see Annex) and is hereby promulgated.
announce.
annex: Medical device clinical trial design guidelines
