Dirección General de Medicamentos, Insumos y Drogas
DIGEMID · Peru · latin america
Peru's medicines, supplies and drugs directorate — leech therapy supervised under Ley General de Salud and complementary-medicine framework, with DIRESA-level enforcement.
Regulatory Profile
- Agency type
- national regulator
- Region
- latin america
- Country
- Peru
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
Relevant Regulation Codes
- Ley General de Salud, Ley Nº 26842
- Ley Nº 29459 — Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios
- DS 016-2011-SA — reglamento para el registro de dispositivos médicos
Prescriber Requirements
- Colegio Médico del Perú-registered MD prescription required
- Enfermero/a application under physician's order
- Medicina complementaria framework administered via EsSalud's CAMEC programme
Supply Chain & GMP
Registro Sanitario via DIGEMID; importer requires Autorización Sanitaria. Spanish-language labelling.
Import/Export Rules
VUCE customs portal + SENASA agricultural-health clearance for live invertebrates. CITES via SERFOR (Servicio Nacional Forestal y de Fauna Silvestre).
Reimbursement Context
EsSalud's CAMEC (Centro de Atención de Medicina Complementaria) network has historically delivered hirudoterapia in regional hospitals — Peru is unusual in Latin America for having an in-system complementary-medicine clinical service.
Key Regulatory Documents
ASH Editorial Notes
EsSalud's CAMEC programme is a rare institutional home for hirudotherapy in the Latin American public sector; ASH research collaboration with Universidad Peruana Cayetano Heredia under discussion (Q2 2026).
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.
ANMAT — Argentina
Argentina's national administration of drugs, food and medical technology — leech-specific regulatory pathway has not been independently verified by ASH.