How to distinguish the categories of medical devices?

The classification principle of medical devices in various countries is generally determined according to their risk levels, 1 is the lowest, followed by 2.3, and so on.

Classification Rules of Medical Devices in China (Order No.2001). 15) "regulation:

Article 4 To determine the classification of medical devices, a comprehensive judgment shall be made according to the structural characteristics, use forms and use conditions of medical devices.

The specific judgment of medical device classification can be based on the Judgment Table of Medical Device Classification (see Annex).