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

      Utility is mainly obtained through physical means, not through pharmacology, immunology or metabolism. Or although these methods are involved, they only play an auxiliary role.

     The purpose is to diagnose, prevent, monitor, treat or alleviate the disease. The aims are diagnosis, monitoring, treatment, mitigation or functional compensation of injury, inspection, substitution, regulation or support of physiological structure or physiological process, support or maintenance of life, pregnancy control and to provide information for medical or diagnostic purposes by examining samples from the human body.