Medical devices refer to instruments, equipment, instruments, in vitro diagnostic reagents, calibrators, materials and other similar or related articles directly or indirectly used for human body, including required computer software.
　　Utility is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or only plays an auxiliary role in spite of these ways.
　　The purpose is to diagnose, prevent, monitor, treat or alleviate the disease; diagnose, monitor, treat, alleviate or compensate for the function of the injury; examine, replace, adjust or support the physiological structure or process; support or maintain the life; control the pregnancy; provide information for medical or diagnostic purposes by examining samples from the human body.