Article 76 The meaning of the following terms in these regulations:
Medical devices, means instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items, including required computer software, that are used directly or indirectly in the human body; their 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 auxiliary role; and its purpose is:
(i) diagnosis, prevention, monitoring, treatment or alleviation of disease;
(ii) diagnosis, monitoring, treatment, alleviation of injuries or functional compensation;
(iii) (iii) the testing, substitution, regulation, or support of physiological structures or processes;
(iv) the support or maintenance of life;
(v) the control of pregnancy;
(vi) the provision of information for medical or diagnostic purposes through the examination of samples from the human body.
Medical device use unit, 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 medical institutions of the blood station, single-collection plasma stations, rehabilitation aids fit institutions.
Large medical equipment, refers to the use of complex technology, large amount of capital investment, high operating costs, the impact of medical costs and large medical devices into the catalog management.