Announcement of the State Food and Drug Administration on the issuance of technical guidelines for clinical trials of in vitro diagnostic reagents (No. 72 of 2021)

In order to guide the clinical trials of in vitro diagnostic reagents, in accordance with the "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents" (State Administration for Market Regulation Order No. 48), the State Food and Drug Administration has organized and formulated the "Guiding Principles for Clinical Trials of In Vitro Diagnostic Reagents" ( (See attachment), it is hereby released. The technical guidelines will be implemented from the date of issuance, and the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents" issued by the former State Food and Drug Administration (formerly CFDA Notice 2014 No. 16) shall be repealed.