Departamento de Regulación y Control de Productos Farmacéuticos y Afines — Ministerio de Salud Pública y Asistencia Social
Guatemala DRCPS · Guatemala · latin america
Guatemala's Department of Regulation and Control of Pharmaceutical Products and Related Items — 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
- Guatemala
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
Relevant Regulation Codes
- Guatemalan Código de Salud (Decreto No. 90-97)
- Guatemalan Reglamento para el Control Sanitario de los Medicamentos y Productos Afines
- Central American Common Market (CACM/MCCA) harmonised pharmaceutical frameworks where applicable
Prescriber Requirements
- Guatemalan Colegio de Médicos y Cirujanos–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Guatemala DRCPS registration as applicable; Spanish-language labelling required by national law. Standard cold-chain conditions.
Import/Export Rules
Guatemala DRCPS and Ministerio de Agricultura, Ganadería y Alimentación clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Instituto Guatemalteco de Seguridad Social (IGSS) 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
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.