Paraguay Medical Device Regulations

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
 
Premarket Approval Process
Paraguay is a part of MERCOSUR (Common Southern Market), which also includes Argentina, Brazil,, Uruguay, Venezuela and Bolivia. Mercosur defines Technical Regulation for medical device registration. However, ParaguayTM regulations are currently unharmonized.
All manufacturers, importers, distributors, or their Authorized Representatives (AR). must register with MSPyBS.
Device are required to meet meet quality assurances and may be audited.
Manufacturers (or AR) are required to present post market vigilance information to MSPyBS.
Additional Information
Postmarket Surveillance Must have surveillance systems in place
Timeline N/A. Currently no approval is required, only listing
Conformity Assessment Required