Dirección General de Medicamentos, Alimentos y Productos Sanitarios — República Dominicana
DIGEMAPS · Dominican Republic · latin america
Dominican Republic's Directorate General of Medicines, Food and Health Products (Ministerio de Salud Pública) — 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
- Dominican Republic
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://digemaps.gob.do
Relevant Regulation Codes
- Dominican Ley General de Salud (Ley 42-01)
- Dominican Ley de Medicamentos (Ley 50-88)
- Dominican national medical device regulatory framework
Prescriber Requirements
- Dominican Colegio Médico–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
DIGEMAPS registration as applicable; Spanish-language labelling required by national law. Standard cold-chain conditions, with logistical constraints typical of Caribbean island distribution.
Import/Export Rules
DIGEMAPS and Ministry of Agriculture clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Sistema Dominicano de Seguridad Social (SDSS) and Seguro Familiar de Salud (SFS) 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. Caribbean regulatory frameworks rely on a mixture of national and regional cooperation; 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.