Classification of medical devices
According to the Regulations on the Supervision and Administration of Medical Devices, the management is from low to high, and the state implements classified management of medical devices according to the degree of risk.
The first category refers to medical devices that can ensure their safety and effectiveness through daily management. The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.
The second category refers to medical devices whose safety and effectiveness should be controlled. The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.
The third category refers to the medical devices implanted in human body to support and maintain life, which are potentially dangerous to human body, and their safety and effectiveness must be strictly controlled.