Legal basis:
"Regulations for the Supervision and Administration of Medical Devices"
Article 4 local people's governments above the county level shall strengthen the leadership of the supervision and management of medical devices in the administrative region, organize and coordinate the supervision and management of medical devices and the response to emergencies within the administrative region, and strengthen the supervision and management of medical devices and capacity-building for medical devices, to provide safeguards for the safety of medical devices. Work to provide security.
Departments of local people's governments at or above the county level responsible for drug supervision and management are responsible for the supervision and management of medical devices in the administrative region. The relevant departments of the local people's governments at or above the county level are responsible for the supervision and management of medical devices in their respective areas of responsibility.
Article 5 of the supervision and management of medical devices follow the principles of risk management, full control, scientific supervision, social **** governance.
Article VI of the state of medical devices in accordance with the degree of risk of the implementation of classification management.
The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Evaluating the degree of risk of medical devices should take into account the intended purpose of the medical device, structural features, methods of use and other factors.