What is a medical device？

Date：2023-02-16

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

Medical devices include medical equipment and medical consumables.

The utility is mainly obtained through physical and other means, not through pharmacology, immunology, or metabolism, or although these methods are involved, they only have auxiliary effects.

The purpose is to diagnose, prevent, monitor, treat or alleviate the disease; Diagnosis, monitoring, treatment, relief or functional compensation of injuries; Testing, substitution, regulation, or support of physiological structures or processes; Support or maintenance of life; Pregnancy control; Provide information for medical or diagnostic purposes by examining samples from the human body.

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