Agencia de Regulación Sanitaria — República de Honduras
ARSA · Honduras · latin america
Honduras' Health Regulatory Agency — 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
- Honduras
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://www.arsa.gob.hn
Relevant Regulation Codes
- Honduran Decreto Ejecutivo PCM-032-2017 (creación de ARSA)
- Honduran Código de Salud (Decreto 65-91)
- Central American Common Market (CACM/MCCA) harmonised pharmaceutical frameworks where applicable
Prescriber Requirements
- Honduran Colegio Médico de Honduras–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
ARSA registration as applicable; Spanish-language labelling required by national law. Standard cold-chain conditions.
Import/Export Rules
ARSA and Secretaría de Agricultura y Ganadería (SENASA) clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Instituto Hondureño de Seguridad Social (IHSS) 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. Central American 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.