How are the types of medical devices divided
Dec 25, 2021
The United States is divided into three categories:
Class1: general medical devices, low risk and not easy to cause personal injury, such as bandages and dental mirrors
Class2: dangerous equipment, such as electric wheelchairs and condoms
Class3: life sustaining devices, such as pacemakers and artificial heart valves
Similar to the United States:
The State Food and drug administration carries out classified management of medical devices, not classification. It is divided into three categories:
The first category refers to medical devices that are sufficient to ensure their safety and effectiveness through routine management.
The second category refers to the medical devices whose safety and effectiveness should be controlled.
The third category refers to implantation into the human body; To support and sustain life; It is potentially dangerous to human body, and its safety and effectiveness must be guaranteed
