What are medical devices?
Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrators, materials, and other similar or related articles, including the necessary computer software, that are used directly or indirectly on the human body; their effects are mainly achieved through physical means, not through pharmacological, immunological, or metabolic means, or although these means are involved, they only play a supporting role; their purpose is:
(a) Diagnosis, prevention, monitoring, treatment, or alleviation of diseases;
(b) Diagnosis, monitoring, treatment, alleviation, or functional compensation of injuries;
(c) Examination, replacement, regulation, or support of physiological structures or physiological processes;
(d) Support or maintenance of life;
(e) Pregnancy control;
(f) Providing information for medical or diagnostic purposes by examining samples from the human body.
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