What are Class II and Class III medical device business enterprise classification?

Medical devices in China are divided into three categories according to the risk level, the first category has the lowest risk (such as adhesive tape without direct contact with wounds), the second category is higher, and the third category has the highest risk (such as hemodialysis solution).

The operation of Class II and Class III devices needs to be registered on the business license, while the operation of Class I devices only needs to be filed with the municipal or provincial bureaus.

If only Class II devices are registered, it means that only Class II devices can be operated. And so on.