Agency
All medical devices are regulated by Direccion de Viglancia Sanitaria del Ministerio de Salud Publica y Bienestar Social (MSPyBS).
Medical Device Definition
A medical device is any instrument, device, equipment, material or article, used alone or in combination, including software programs that contribute to function, designed for use in humans with the purpose to:
- Diagnose, prevent, control, treat or alleviate a disease
- Diagnose, control, treat, alleviate or compensate for an injury or a handicap
- Investigate, substitution or modification of the anatomy of a physiological process
- Regulate conception and the principal intended action in or on the human body is not achieved by pharmacological, immunological, or metabolic means