Definition of medical devices: medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents, calibrators, materials and other similar or related items directly or indirectly used in human body, including required computer software; Its effectiveness is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although these means are involved, they only play an auxiliary role; Its purpose is:
(a) The disease is being diagnosed, prevented, monitored, treated or alleviated;
(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injury;
(3) Examination, substitution, adjustment or support of physiological structure or process;
(4) supporting or maintaining life;
(5) Pregnancy control;
(6) provide information for medical or diagnostic purposes by examining human samples.