Medical devices are equipment, apparatus, material, article or system for medical, dental, or laboratory use or application, intended for prevention, diagnosis, treatment, rehabilitation, or contraception and which do not use pharmacological, immunological, or metabolic means to carry out their main function in human beings, but may be aided in its functions by such means. See Annex I of Resolution RDC No. 185, of October 22, 2001.

Any medical device whose operation depends on a source of electrical energy or any other source of power other than that generated by the human body or gravity, and which works by converting this energy. Medical products intended to transmit energy, substances, or other elements between an active medical product and the patient, without causing a significant change, are not considered active medical products.

Any active medical device used alone or in combination with other medical products, intended to provide information for the detection, diagnosis, monitoring, or treatment of physiological or health conditions, diseases, or congenital deformities.

Any active medical device, used alone or in combination with other medical products, intended to support, modify, replace or restore biological functions or structures, in the context of treating or alleviating an illness, injury or disability.