2 medical device: medical device refers to the direct or indirect use of the human body instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items, including the need for computer software; its utility is mainly through the physical and other ways to obtain, not through the pharmacological, immunological or metabolic way to obtain, or although there are these ways to participate in, but only to play an auxiliary role; its purpose is to disease. ancillary; the purpose of which is the diagnosis, prevention, monitoring, treatment, or mitigation of disease; the diagnosis, monitoring, treatment, mitigation, or functional compensation of injury; the examination, replacement, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of specimens derived from the human body.