Medical device supervision follows the principles of risk management, full control, scientific supervision, social **** governance.
In order to strengthen the supervision and management of medical device business, standardize medical device business activities, to ensure the safety and effectiveness of medical devices, according to the "supervision and management of medical devices regulations", the development of these measures. In the Chinese people's *** and the country engaged in medical device business activities and its supervision and management, shall comply with these measures.
Engaged in medical device business activities, shall comply with the laws, regulations, rules, mandatory standards and medical device business quality management standards and other requirements to ensure that the medical device business process information is true, accurate, complete and traceable. Medical device registrants, filers can sell their own, but also can be entrusted to the medical device business enterprises to sell their registered, filed medical devices.
Medical Devices:
Directly or indirectly used in the human body of instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items medical devices refers to directly or indirectly used in the human body of instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items. related articles, including the required computer software.
Medical devices include medical equipment and medical consumables. Effectiveness is obtained primarily by physical and other means, not by pharmacological, immunological, or metabolic means, or although these means are involved but only in an ancillary manner.
The purpose is the diagnosis, prevention, monitoring, treatment, or mitigation of disease; the diagnosis, monitoring, treatment, mitigation, or functional compensation of injury; the testing, 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.