Medical device means an instrument, equipment, apparatus, material, including the required software, used alone or in combination in the human body; its action is not obtained by pharmacological, immunological or metabolic means, but may have these means involved and play a certain supporting role; so as to achieve the following intended purposes: (i) prevention, diagnosis, treatment, monitoring, alleviation of disease; (ii) diagnosis, treatment, monitoring, alleviation, compensation of injury or disability; (iii) study, substitution, regulation of anatomical or physiological processes; (iv) pregnancy control. diagnosis, treatment, guardianship, palliation, and compensation for injury or disability; (iii) the study, substitution, and regulation of anatomical or physiological processes; and (iv) pregnancy control.