Extension of Exemption List for Medical Devices and IVDs soon

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:

Proposed amendment for the list of medical devices to be exempted from clinical trials

Proposed amendment for the list of IVDs to be exempted from clinical trials

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.