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The role of medical devices

2020-12-28

Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related articles directly or indirectly used for human body, including required computer software.

Utility is mainly obtained through physical and other ways, not through pharmacology, immunology or metabolism, or although these ways are involved, they only play an auxiliary role.

The purpose is the diagnosis, prevention, monitoring, treatment or remission of disease; the diagnosis, monitoring, treatment, remission or functional compensation of injury; the inspection, replacement, regulation or support of physiological structure or physiological process; the support or maintenance of life; pregnancy control; through the examination of samples from the human body, to provide information for medical or diagnostic purposes.