Chile Medical Device Regulations

Medical devices or articles for medical use: Any instrument, apparatus, application, material, or item, including software, used alone or in combination and defined by the manufacturer to be used directly on human beings, provided its main intended action is on the human body. It is not achieved by pharmacological, immunological, or metabolic means, although such means may contribute to its function; for diagnosis, prevention, monitoring, treatment, or alleviation of disease, injury, or disability; research or replacement or modification of the anatomy or a physiological process, or regulation of conception.

Active Medical Device: any device whose operation depends on electrical energy or any source of distinct energy generated directly by the human body or by gravity and which acts through conversion of energy. Active medical devices are not considered to be products intended to transmit energy, substances or other elements of an active medical device to the patient without any significant modification.

Therapeutic Active Medical Device: any medical device used alone or in combination with other medical devices intended to support, modify, replace or restore functions or biological structures in the context of treatment or relief of an illness, injury or disability.

Active Medical Device for Diagnosis: any active medical device used alone or in combination with other medical devices intended to provide information for the detection, diagnosis, control or treatment of physiological states, health states, illnesses or congenital malformations.