The first category is a low degree of risk, the implementation of routine management can ensure its safety and effectiveness of medical devices, such as ordinary surgical knives and scissors, dressings 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 medical sutures.
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 a variety of syringes, infusion sets, pacemakers, artificial heart valves, artificial joints, vascular stents and so on.
Expanded Information
Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including required computer software.
Utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or is involved but only in an ancillary manner.
Purposes are the diagnosis, prevention, monitoring, treatment, or alleviation of disease; the diagnosis, monitoring, treatment, alleviation, or functional compensation of injury; the examination, replacement, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of specimens from the human body.
References: