Article 3 The medical devices referred to in these regulations refer to instruments, equipment, apparatus, materials or other articles, including the required software, used alone or in combination in the human body; their use on the human body surface and in the body is not obtained by pharmacological, immunological or metabolic means, but there may be a participation of these means and plays a certain auxiliary role; and their use is intended to achieve the following intended purposes:< /p>
(i) the prevention, diagnosis, treatment, monitoring, and alleviation of disease;
(ii) the diagnosis, treatment, monitoring, alleviation, and compensation of injury or disability;
(iii) the study, substitution, and regulation of anatomical or physiological processes;
(iv) the control of pregnancy.