China Center for Medical Device Evaluation (CMDE) of NMPA announced the Catalog of Medical Devices Exempted from Clinical Trials for exposure draft. There are 142 medical devices added in the new clinical trial exempt catalog and the description of 22 medical devices modified. It is to further standardize the clinical evaluation of medical devices, and expand the scope of the list of medical devices exempted from clinical trials.
Please note that a device that has the same classification as a device on the exemption list doesn’t guarantee that it is exempt from clinical trials and there may be additional criteria that need to be fulfilled, Likewise, a clinical trial may not be necessary if similar devices have been on the market for a long time and are supported by safety records with no reports of serious adverse events.
If a medical device listed on the clinical trial exemption list with new technical, new material or new indication, clinical trials would be required, and in accordance with the Technical guidelines for clinical evaluation of medical devices, For import medical device, as its overseas clinical trials in accordance with China's relevant laws and regulations in the corresponding technical requirements, such as sample size, the control group evaluation, evaluation index and evaluation principles, evaluation requirements, the applicant can submit the clinical trial data which submitted to the foreign medical device department when registered in county of origin. The clinical data should include at least the opinion of the ethics committee, the clinical trial protocol, and the clinical trial report. The applicant should also submit relevant supporting data demonstrating whether there are racial differences in the clinical performance and/or safety of the product