Medical devices, refers to the direct or indirect use of the human body of instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items, including the need for computer software; its utility is mainly through the physical and other ways to obtain, not through the pharmacology, immunology or metabolism of the way to obtain, or although there are these ways to participate in the role of aids only; the purpose is:
This is the first time that a medical device is used in the human body of the body of a person. purposes are:
(i) diagnosis, prevention, monitoring, treatment, or alleviation of disease;
(ii) diagnosis, monitoring, treatment, alleviation, or functional compensation of injury;
(iii) testing, substitution, modulation, or support of physiological structures or processes;
(iv) support or maintenance of life;
(v) pregnancy control;
(vi) the provision of information for medical or diagnostic purposes through the examination of samples from the human body.