On July 29, 2020 the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) released a draft of the proposed amendment to the list of medical devices and IVDs to be exempted from clinical trials:
The draft proposes to add 53 medical devices (Class II: 34; Class III: 19) and 15 IVDs (Class II: 13; Class III: 2) to the clinical trial exemption list. Also, the names and descriptions of 11 medical devices (Class II: 9; Class III: 2) are proposed for revision, while there are 2 medical devices being combined with other products.
Here are the links to:
The CMDE is currently soliciting for public comments, and the public consultation ends on August 31, 2020.
By Jacky Li. Contact Cisema if you would like to learn more.