NMPA Collects Public Comments On Adjusting Medical Device Clinical Evaluation Catalog And IVD Clinical Trial Exemption Catalog


On July 5, 2022, the NMPA issued a notice collecting public comments on the catalogues of medical devices exempted from clinical evaluation and IVD exempted from clinical trials.

NMPA released the Proposed New and Revised Catalogue of Medical Devices Exempted from Clinical Evaluation (2022 Draft for Comments). This new medical device catalog exempted from clinical evaluation includes neurological and cardiovascular surgery devices, medical diagnostic and monitoring devices,respiratory, anesthesia and first aid devices, blood transfusion, dialysis and extracorporeal circulation devices, passive implants instruments, ophthalmic devices, dental instruments and  the most modified category is infusion, nursing and protective devices.

It is a great opportunity to have your voices heard by NMPA reviewers and influence them to form a more practical Catalog in the end. If you have any comments on the Clinical Evaluation/Clinical Trial Exemption Catalog, please contact info@bradyknowsmedical.com before July 31, 2022. We will help you submit your comments to NMPA before August 8, 2022.