Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, 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:
(1) Diagnosis, prevention, monitoring, treatment or alleviation of diseases;
(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.
Medical device users refer to institutions that use medical devices to provide medical and other technical services to others, including medical institutions that have obtained the Practice License of Medical Institutions, family planning technical service institutions that have obtained the Practice License of Family Planning Technical Service Institutions, and blood stations, plasma collection stations and rehabilitation AIDS adaptation institutions that do not need to obtain the Practice License of Medical Institutions according to law.