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. Such as bandages, bandages, swabs and so on.
The second category is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices. Such as thermometers, blood pressure monitors, home blood glucose meters, hearing aids, wheelchair vans and so on.
The third category is a higher risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices. Such as contact lenses and their care solution and so on.
Expanded Information
According to Article 5 of the Rules for the Classification of Medical Devices, medical devices can be divided into the following situations:
(a) According to the difference in structural features, they are divided into passive medical devices and active medical devices.
(ii) According to whether contact with the human body, divided into contact with the human body devices and non-contact human body devices.