Definition of medical devices: medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly on the human body, including the required computer software; its utility is mainly through physics, etc. Ways to obtain, not through pharmacology, immunology or metabolism, or although these methods are involved but only play an auxiliary role; its purpose is:
(1) The disease is diagnosed, prevented, monitored, treated or alleviated;
(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injury;
(3) Inspection, substitution, adjustment or support of physiological structure or physiological process;
(4) Life support or maintenance;
(5) Pregnancy control;
(6) Provide information for medical or diagnostic purposes by examining samples from human bodies.
