NMPA Medical Device Approval Analysis in July 2020

In July 2020, CMDE has released 1,414 pieces of information related to medical device approval, among which nearly 51% (728) of them are related to imported medical devices. Based on the information collected from the CMDE website, the registration of renewal (364, 50%) accounts for the majority while the registration change (333, 46%) and initial registration (31, 4%) took a smaller part for the imported medical device approval. Furthermore, 53% of the registration of change is the change of permission items and 47% of them are the change of registry items. Therefore, the change of permission items plays a vital role in the imported medical device approvals in July.

In addition, six of the imported medical devices were not allowed to register initially and two of the imported medical devices were not allowed to conduct the change of permission items. For more information about the imported medical devices in June, please contact China Med Device (Email: info@chinameddevice.com).