With the rapid development of the industry and continuous emergence of new technologies, new materials and new products, the “Medical Device Classification Catalog”, effective from August 2018, is in the process of real-time dynamic adjustment. The latest changes were that certain neurosurgical and cardiac surgery devices are down classified from Class III to Class II in March 2022 (LINK HERE).

China Med Device, LLC summarized the classification and definition of medical devices and IVDs, to direct applicants for registration application.

1. Medical Devices Classification Catalog (August 31, 2017) LINK HERE
2. Adjustment of the “Medical Device Classification Catalog” (December 18, 2020) LINK HERE
3. Classification and Definition of Recombinant Collagen Medical Products (April 15, 2021)
4. Work Procedures for the Dynamic Adjustment of the Medical Devices Classification (May 8, 2021) LINK HERE
5. Classification and Definition of Artificial Intelligence Medical Software Products (July 8, 2021) LINK HERE
6. Class I Medical Device Product Catalog (December 31, 2021)
7. Adjustment of the “Medical Device Classification Catalog” (March 22, 2022) LINK HERE
8. Adjustment of the “Medical Device Classification Catalog” (March 30, 2022)