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Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items that are directly or indirectly used in the human body, including required computer software; It is not obtained by pharmacological, immunological or metabolic methods, or although these methods are involved but only play an auxiliary role; its purpose is: (1) Disease diagnosis, prevention, monitoring, treatment or mitigation; (2) Injury diagnosis (3) Inspection, replacement, adjustment or support of physiological structure or physiological process; (4) Life support or maintenance; (5) Pregnancy control; Samples are examined to provide information for medical or diagnostic purposes. 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 a medical institution practice license, family planning technical service institutions that have obtained a family planning technical service institution practice license, and legal Blood stations, apheresis stations, rehabilitation aids adaptation institutions, etc. that need to obtain a medical institution practice license.