Class I is a low risk; Class II has a moderate risk.
The state of medical devices in accordance with the level of risk to implement classification management.
1, the first class is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
2, the second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
3, 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.
Expanded information:
Medical devices:
Medical devices refers to the direct or indirect use of the human body of the instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items, including required computer software.
The utility is obtained primarily by physical means, not by pharmacological, immunological or metabolic means, or only in an ancillary manner although these means are involved.
The purpose is the diagnosis, prevention, monitoring, treatment or alleviation of disease; the diagnosis, monitoring, treatment, alleviation or functional compensation of injury; the examination, substitution, modulation or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; the provision of information for medical or diagnostic purposes by the examination of specimens from the human body.
Baidu Encyclopedia - Medical Devices