Two, "Regulations for the Supervision and Administration of Medical Devices" (State Council Decree No. 650)
Medical devices, refers to instruments, devices, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software; their utility is mainly obtained by physical and other means, not by pharmacological, immunological, or metabolic means, or which, although involved in these means, play only an auxiliary role; and whose purpose is:
(i) diagnosis, prevention, monitoring, treatment, or mitigation of disease;
(ii) diagnosis, monitoring, treatment, mitigation, or functional compensation of injury;
(iii) physiological structure or physiological processes;
(iv) support or maintenance of life;
(v) pregnancy control;
(vi) providing information for medical or diagnostic purposes through the examination of samples from the human body.
Medical device use units, refers to the use of medical devices for others to provide medical and other technical services, including medical institutions to obtain a license to practice medical institutions, family planning technical service institutions to obtain a license to practice family planning technical service institutions, as well as the law does not need to obtain a license to practice in the medical institutions of the blood station, single plasma station, rehabilitation aids fit institutions.
Article IV of the State of medical devices in accordance with the degree of risk to implement classification management.
The first category is a low degree of risk, the implementation of routine management can ensure its safety, effective 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 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.