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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 clinical trials of in vitro diagnostic reagents, in accordance with the "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents" (Order of the State Administration for Market Supervision and Administration) No.
48), the State Food and Drug Administration has organized and formulated the "In Vitro Diagnostic Reagents Clinical Trial Technical Guidelines" (see appendix), which 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16) shall be repealed
.
Hereby inform
.
Attachment: Technical guidelines for clinical trials of in vitro diagnostic reagents National Food and Drug Administration September 16, 2021
72 of 2021) In order to guide clinical trials of in vitro diagnostic reagents, in accordance with the "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents" (Order of the State Administration for Market Supervision and Administration) No.
48), the State Food and Drug Administration has organized and formulated the "In Vitro Diagnostic Reagents Clinical Trial Technical Guidelines" (see appendix), which 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16) shall be repealed
.
Hereby inform
.
Attachment: Technical guidelines for clinical trials of in vitro diagnostic reagents National Food and Drug Administration September 16, 2021
