The first batch: 69 varieties of 9 categories in the class III of high-risk medical devices have been implemented since January 1, 2021.
The second batch: the rest of the class III medical devices (including in vitro diagnostic reagents).
The second batch of unique identification (UDI) for medical devices has been implemented from June 1, 2022.
Support and encourage other medical devices to implement unique identification.
UDI is the “identity card” of medical devices. The implementation of UDI can realize the transparency, visualization and intelligence of production, operation, use and supervision. Improve product traceability, promote smart supervision, ensure consumer safety, and help the high-quality development of the industry.