2020, July 29th, in order to further standardize the clinical evaluation of medical devices and expand the scope of the catalogue of medical devices exempt from clinical trials, the Center for Medical Device Evaluation of NMPA organized the revision of the catalogue of medical devices exempt from clinical trials. The "New and Revised Catalogue of Medical Devices Exempt from Clinical Trials in 2020 (Draft for Comment)" and the "New and Revised Catalogue of In Vitro Diagnostic Reagents Exempt from Clinical Trials in 2020 (Draft for Comments)" were published.
[NMPA] New and Revised Catalogue of Medical Devices Exempted from Clinical Trials (Draft for Comment)
by Yolanda
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