Dirección Nacional de Vigilancia Sanitaria — Ministerio de Salud Pública y Bienestar Social
DINAVISA · Paraguay · latin america
Paraguay's National Directorate of Health Surveillance (Ministry of Public Health) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national pharmaceutical and medical device framework as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- latin america
- Country
- Paraguay
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://www.dinavisa.gov.py
Relevant Regulation Codes
- Paraguayan Ley 1119/97 De productos para la salud y otros
- Paraguayan national medical device regulatory framework
- MERCOSUR harmonised pharmaceutical and medical device frameworks where applicable
Prescriber Requirements
- Paraguayan Círculo Paraguayo de Médicos–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
DINAVISA registration as applicable; Spanish-language labelling required by national law (with Guaraní supplementary information where relevant). Standard cold-chain conditions.
Import/Export Rules
DINAVISA and Servicio Nacional de Calidad y Salud Animal (SENACSA) clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Instituto de Previsión Social (IPS) coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. MERCOSUR regulatory frameworks rely on a mixture of national and regional harmonisation; whether this captures live-organism medical devices has not been independently mapped by ASH.
Related Jurisdictions
ANVISA — Brazil
Brazil's national health-surveillance agency — leech therapy regulated as a medical device with parallel coverage under the SUS Practices Integrativas e Complementares (PICS) policy.
INVIMA — Colombia
Colombia's national medicines and devices surveillance agency — leech therapy regulated as a medical device under Decreto 4725/2005 with TM/CAM oversight by the Ministerio de Salud.
DIGEMID — Peru
Peru's medicines, supplies and drugs directorate — leech therapy supervised under Ley General de Salud and complementary-medicine framework, with DIRESA-level enforcement.
ANMAT — Argentina
Argentina's national administration of drugs, food and medical technology — leech-specific regulatory pathway has not been independently verified by ASH.