This article provides a general overview of the current medical device regulations in Paraguay.
Medical device regulations in Paraguay are set forth by the Direccion de Viglancia Sanitaria del Ministerio de Salud Publica y Bienestar Social (MSPBS). Medical devices in Paraguay are not classified. However, since Paraguay is a member of Mercosur, all medical devices intended to be marketed in Paraguay should be compliant with MSPBS regulations and Mercosur guidelines.
Mercosur is a South American trade bloc that was established in order to secure the movement of people, goods, and currency amongst its members. Other members of Mercosur include Argentina, Brazil, Uruguay, and Venezuela (which has been suspended since December 1, 2016). Associate countries include Bolivia, Chile, Colombia, Ecuador, Guyana, Peru, and Suriname.
Registering Your Medical Device in Paraguay
While MSPBS does not classify medical devices or require that they gain “approval,” all medical devices marketed in Paraguay must be registered with MSPBS, meet quality assurance standards, and be compliant with Mercosur guidelines. Mercosur has specified ten harmonized medical device “resolutions” that countries belonging to the trade bloc are required to follow. These resolutions discuss premarket approval, proof of safety and efficacy of medical devices, GMP certification, training of inspectors, and postmarket surveillance.
All medical devices imported into Paraguay must have its country of origin mentioned on the label. Expiration dates and warning symbols for hazardous products are also required to be included on the device label.
Conformity assessment is required and MSPBS may ask for further review by external inspectors, scientists, and experts. Manufacturers are also required to provide MSPBS with postmarket vigilance information. MSPBS may ask for further information on safety and audit manufacturing sites.