Medical device, refers to the use of the human body, alone or in combination, instruments, equipment, appliances, materials or other items, including the required software; its use on the human body surface and in vivo is not obtained by means of pharmacology, immunology or metabolism, but may have the participation of these means and plays a certain role in assisting ; its use is intended to achieve the intended purpose of (i) the prevention, diagnosis, treatment, monitoring, and mitigation of disease; (ii) the diagnosis, treatment, monitoring, mitigation, and compensation of injury or disability; (iii) the study, substitution, and regulation of anatomical or physiological processes; and (iv) the control of pregnancy.