Medical device supervision and management follow 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 this approach. 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:
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 the required computer software.
The utility of which is obtained primarily by physical means, not by pharmacological, immunological or metabolic means, or which, although involved in these means, plays only an auxiliary role; the purpose of which is the diagnosis, prevention, guardianship, treatment or alleviation of disease; the diagnosis, guardianship, treatment, alleviation, or compensation of the function of an injury; the examination, substitution, modulation, or support of a physiological structure or a physiological process
The support or maintenance of life; the provision of information for medical or diagnostic purposes through the examination of samples from the human body.