What Are Medical Devices?
"Medical devices" means instruments, equipment, utensils, in vitro diagnostic reagents and calibrators, materials, and other similar or related items, including required computer software, which is directly or indirectly used in the human body.
Its utility is obtained mainly by physical means, not by pharmacological, immunological, or metabolic means, or although these methods are involved, they only play a supplementary role. The purpose is to diagnose, prevent, monitor, treat or alleviate diseases; Diagnosis, monitor, treat, mitigation or functional compensation of injury; The examination, substitution, adjustment, or support of physiological structures or processes; Life support or maintenance; Pregnancy control; Examination of samples from the human body to provide information for medical or diagnostic purposes.
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