The United States is divided into three categories:
Class1: general medical devices, low-risk, not likely to cause personal injury, such as bandages and dental mirrors
Class2: devices with a certain degree of risk, such as motorized wheelchairs and condoms
Class3: life-sustaining devices, such as pacemakers and artificial heart valves
The country and the U.S. pretty much the same:
The State Food and Drug Administration classifies medical devices, not grades them. ***Divided into three categories:
The first category refers to, through routine management is sufficient to ensure the safety and effectiveness of medical devices.
The second category refers to, its safety, effectiveness should be controlled medical devices.
The third category refers to, implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety, effectiveness must be
strictly controlled medical devices.