Ministerio de Salud de Costa Rica — Dirección de Regulación de Productos de Interés Sanitario
MS-DRPIS · Costa Rica · latin america
Costa Rica's Ministry of Health drug and device registry — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- latin america
- Country
- Costa Rica
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
Relevant Regulation Codes
- Costa Rican Ley General de Salud
- Costa Rican national medical device regulatory framework
Prescriber Requirements
- Colegio de Médicos y Cirujanos de Costa Rica–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Ministry of Health registration as applicable; Spanish-language labelling. Standard cold-chain conditions.
Import/Export Rules
Ministry of Health import authorisation; SENASA (Servicio Nacional de Salud Animal) clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Not covered under public insurance schemes for leech therapy specifically.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. Costa Rica's Caja Costarricense de Seguro Social (CCSS) provides universal coverage but does not enumerate hirudotherapy as a covered modality based on ASH review.
Related Jurisdictions
COFEPRIS — Mexico
Mexico's federal health-risk authority — leech therapy regulated as a medical device under General Health Law, with traditional-medicine carve-outs at state level.
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.