The state has implemented classification management of medical devices.
The first class refers to medical devices whose safety and effectiveness can be guaranteed through routine management.
The second category refers to the safety and effectiveness of medical devices should be controlled.
The third category refers to the implantation of the human body; used to support, maintain life; the human body is potentially dangerous, its safety and effectiveness must be strictly controlled medical devices.
From Class I to Class III, the risk level goes from low to high.
The first class is issued a registration certificate by the municipal drug administration
The second class is issued a registration certificate by the provincial drug administration
The third class is issued a registration certificate by the national drug administration
Also, the medical devices in the United States are divided into three classes, which are basically similar to those in our country.