Instituto Nacional de Vigilancia de Medicamentos y Alimentos
INVIMA · Colombia · latin america
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.
Regulatory Profile
- Agency type
- national regulator
- Region
- latin america
- Country
- Colombia
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.invima.gov.co
Relevant Regulation Codes
- Decreto 4725 de 2005 — Régimen de Registros Sanitarios para dispositivos médicos
- Resolución 2003 de 2014 — habilitación de servicios de salud
- Resolución 3823 de 2016 — registros sanitarios de productos
Prescriber Requirements
- Médico con tarjeta profesional vigente prescription required
- Enfermero/a application under physician's order
- Medicina alternativa y complementaria recognised by Ministerio de Salud — physicians with postgraduate complementary-medicine training can deliver hirudoterapia
Supply Chain & GMP
INVIMA Registro Sanitario for the device; importer requires Visto Bueno. Spanish-language labelling mandatory.
Import/Export Rules
Importers submit through VUCE (Ventanilla Única de Comercio Exterior); ICA (Instituto Colombiano Agropecuario) clearance for live invertebrates. CITES via Autoridad Nacional de Licencias Ambientales (ANLA).
Reimbursement Context
Plan de Beneficios en Salud (PBS) generally does not include hirudoterapia; private payment or MIPRES (acceptance of non-PBS items by physician justification) is the typical route.
Key Regulatory Documents
- Decreto 4725 de 2005 (2005)
ASH Editorial Notes
Colombia recognises complementary medicine specialities including hirudoterapia at postgraduate level; the Universidad El Bosque hosts the country's most established training programme.
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.
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.