The so-called medical device means an instrument, equipment, appliance, material or other article, including the required software, used alone or in combination on the human body; whose use on the surface of the human body and in the body is not obtained by pharmacological, immunological or metabolic means, but which may be involved in and play a certain supporting role; and whose use is intended to achieve the following intended purposes:
( (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.
This makes it clear that any device that claims to have the above "preventive, diagnostic, therapeutic" functions is a healthcare device, and the "healthcare device" that we usually understand basically belongs to this category.