In a bid to better standardize its assessment of medical devices, China’s Center for Medical Device Evaluation has published revised catalogs of medical devices and in vitro diagnostic reagents that are 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 Comment)” were released in July. Both catalogs are broader in scope than previous editions.
