Instituto Nacional de Higiene Rafael Rangel — Venezuela
INHRR · Venezuela · latin america
Venezuela's Instituto Nacional de Higiene Rafael Rangel (Ministerio del Poder Popular para la Salud) — 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
- Venezuela
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://www.inhrr.gob.ve
Relevant Regulation Codes
- Venezuelan Ley de Medicamentos (Decreto N° 1.469)
- Venezuelan Reglamento de la Ley de Medicamentos
- Venezuelan national medical device regulatory framework
Prescriber Requirements
- Venezuelan Colegio de Médicos–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
INHRR registration as applicable; Spanish-language labelling required by national law. Standard cold-chain conditions; logistical constraints typical of the contemporary Venezuelan economic environment.
Import/Export Rules
INHRR and Ministry of Popular Power for Productive Agriculture and Lands clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana. International sanctions environment may further restrict commercial flows.
Reimbursement Context
Venezuelan public health system 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. The contemporary Venezuelan regulatory environment is challenging for any independent verification work; this entry should be treated as preliminary and confirmed with Venezuelan regulatory counsel before any operational use.
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.