Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos
CECMED · Cuba · latin america
Cuba's Centre for State Control of Medicines and Medical Devices — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework or traditional and natural medicine pathways as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- latin america
- Country
- Cuba
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://www.cecmed.cu
Relevant Regulation Codes
- Cuban national medical device and medicines law
- Cuban framework for medicina natural y tradicional (MNT) as appropriate
Prescriber Requirements
- Cuban-licensed physician (médico) under Ministry of Public Health authority — order required for any biomedical device application
- Practitioners of medicina natural y tradicional may have separate scope under Cuban national law; specific hirudotherapy authorisation not independently verified by ASH
Supply Chain & GMP
CECMED registration as applicable; Spanish-language labelling. Standard cold-chain conditions.
Import/Export Rules
CECMED import licence requirements; veterinary clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Not covered under public insurance schemes for leech therapy specifically.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. Cuba has formally integrated medicina natural y tradicional (MNT) into its national health system; whether hirudotherapy is recognised within MNT or under CECMED's device pathway 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.
WHO — Global (United Nations specialised agency)
Global health authority — Hirudo medicinalis listed in the WHO Monographs on Selected Medicinal Plants (informational) and embedded in the Traditional Medicine Strategy 2014–2023 and 2025–2034 successor.