Second, the "supervision and management of medical devices regulations"
Article 4 of the State of the medical device according to the degree of risk of the implementation of the classification and 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 its safety and effectiveness of medical devices.