Ministerio de Salud Pública del Uruguay — Departamento de Tecnología Médica
Uruguay MSP · Uruguay · latin america
Uruguay's Ministry of Public Health, Department of Medical Technology — 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
- Uruguay
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
Relevant Regulation Codes
- Uruguayan Decreto-Ley 15.443 on medicinal products
- Uruguayan national medical device regulatory framework
- Mercosur harmonised pharmaceutical and medical device frameworks (where applicable)
Prescriber Requirements
- Uruguayan Colegio Médico–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
MSP registration as applicable; Spanish-language labelling required by national law. Standard cold-chain conditions.
Import/Export Rules
MSP and Ministry of Livestock, Agriculture, and Fisheries clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana. Mercosur customs procedures apply.
Reimbursement Context
Fondo Nacional de Recursos (FNR) and Sistema Nacional Integrado de Salud (SNIS) 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. Uruguay shares elements of pharmaceutical and device regulation with the Mercosur partners (Argentina ANMAT, Brazil ANVISA, Paraguay DNVS).
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.