NMPA Announces New and Revised Catalogues of Medical Devices Exempted from Clinical Trials

2021-01-20 16:55:25 vcc 27

As per the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of Examination & Approval System to Encourage Innovation in Drugs and Medical Devices, and the State Council's requirements for deepening the reform ofStreamlining Administration, Delegating More Powers to Lower-level Governments and Society, Improving Regulation and Optimizing Services, to further improve the management of medical device registration, according to the Regulations for the Supervision and Administration of Medical DevicesProvisions for Medical Device Registration, and Provisions for Registration of In Vitro Diagnostic Reagents, NMPA organized the formulation of new and revised catalogs (omitted) of medical devices and in vitro diagnostic reagents exempt from clinical trials, which have been announced on December 20, 2019, and will take effect from the date of promulgation.