Library / regulatory-reference
Paraguay: National Directorate of Sanitary Surveillance (DINAVISA)
Audience: administrators-policy, researchers-scientists ยท Review state: published
The national authority
The National Directorate of Sanitary Surveillance, known by its Spanish initials DINAVISA, is Paraguay's national authority for sanitary registration and surveillance of medicines and other health products, operating under the Ministry of Public Health.
Paraguay's medicine supply is import-dominated, and the directorate's registration and inspection work governs market entry and continued sale.
How products enter the market
Medicines require sanitary registration after evaluation of quality, safety and efficacy documentation, and establishments are licensed and inspected.
Post-market work includes surveillance, sampling and recalls, with border control playing an important role given the region's significant informal cross-border trade.
Regional and international role
The directorate participates in regional regulatory cooperation in South America, including harmonization discussions among neighboring national authorities.
Its position on a major trade corridor makes its anti-falsification and border-control work relevant beyond the national market.
Using this profile
The directorate publishes regulations and announcements in Spanish through its official portal, which is the primary source for current rules and listed in this profile's internal reference record.
For cross-country comparison: DINAVISA illustrates the ministry-directorate model: sanitary surveillance run from inside the health ministry, with border enforcement as a defining challenge.
Limitations
Educational profile of a national regulatory system, current as of drafting. It simplifies routes and classes and is not legal, regulatory, or clinical advice. Filing and compliance decisions must be confirmed against the authority's current published rules and, where needed, professional regulatory counsel.