Article 76 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, used directly or indirectly for the human body; their utility is primarily 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 compensation of the function of an 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, plasma stations, single-collection plasma stations, rehabilitation aids and other adaptive institutions.