What are the provisions of our country on the classification and grading management of medical devices

The state has implemented classification and management of medical devices. The first category is low risk, the implementation of routine management can ensure its safety and effectiveness of medical devices; the second category is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices; the third category is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.

Article 6 of the Regulations for the Supervision and Administration of Medical Devices

The state implements the classification and management of medical devices in accordance with the degree of risk.

The first category is low-risk medical devices, the implementation of routine management can ensure their safety and effectiveness.

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 its safety and effectiveness of medical devices.