Agencia Nacional de Regulación, Control y Vigilancia Sanitaria
ARCSA · Ecuador · latin america
Ecuador's national agency for sanitary regulation, control and surveillance — leech-specific regulatory pathway has not been independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- latin america
- Country
- Ecuador
- Leech status
- unregulated
- Last ASH review
- 2026-05-25
Relevant Regulation Codes
- Ley Orgánica de Salud (Ecuadorian Organic Health Law)
- ARCSA medical device regulatory framework
Prescriber Requirements
- Ecuadorian medical college-registered MD prescription required
- Constitution of Ecuador (2008) recognises ancestral and intercultural medicine; specific scope of traditional medicine practitioners for hirudotherapy not independently verified by ASH
Supply Chain & GMP
ARCSA product registration if classified as a medical device; Spanish-language labelling.
Import/Export Rules
ARCSA import authorisation plus AGROCALIDAD veterinary clearance for live invertebrates; CITES Appendix II paperwork.
Reimbursement Context
IESS (Ecuadorian Social Security Institute) and private insurance coverage for hirudotherapy not independently verified by ASH.
ASH Editorial Notes
Ecuador's 2008 Constitution gives constitutional recognition to ancestral and intercultural medicine (Article 360); the regulatory status of medicinal leeches in this framework has not been independently verified 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.