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What Is A Medical Device?

Sep 03, 2018


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


The utility is obtained primarily by physical means, not by pharmacological, immunological or metabolic means, or although it is involved in these ways, it only serves as an auxiliary.


The purpose is to diagnose, prevent, monitor, treat or alleviate the disease; diagnose, monitor, treat, relieve or compensate for the damage; test, replace, regulate or support the physiological structure or physiological process; support or maintain life; pregnancy control; Provide information for medical or diagnostic purposes by examining samples from the human body.