The first category is a 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 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.