Introduction to Medical Devices

Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items that are 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 by physical means, not by pharmacological, immunological or metabolic means, or although these means are involved but only play an auxiliary role.

The purpose is diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation or functional compensation of injury; inspection, replacement, adjustment or support of physiological structure or physiological process; life support or maintenance; pregnancy control; Provides information for medical or diagnostic purposes by examining samples from the human body.