Comisión Federal para la Protección contra Riesgos Sanitarios
COFEPRIS · Mexico · north america
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.
Regulatory Profile
- Agency type
- national regulator
- Region
- north america
- Country
- Mexico
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.gob.mx/cofepris
Relevant Regulation Codes
- Ley General de Salud (LGS), Title XII — Sanitary Control of Goods and Services
- Reglamento de Insumos para la Salud, Art. 82–86 (Medical Devices)
- NOM-241-SSA1-2021 (GMP for medical devices)
Prescriber Requirements
- Cédula profesional (federal medical licence) required for prescribers — typically MD or specialist surgeon
- Practitioners must register with the State Sanitary Authority for procedures under COFEPRIS jurisdiction
- Allied health application permitted under physician supervision per institutional protocol
Supply Chain & GMP
Importers and distributors require Aviso de Funcionamiento and, if commercial, a Licencia Sanitaria. Cold-chain storage equivalent to international standards. Spanish-language labelling mandatory.
Import/Export Rules
Import via Permiso Sanitario from COFEPRIS, plus SENASICA (animal health) permit for live invertebrates. NAFTA / USMCA harmonisation does not waive sanitary registration.
Reimbursement Context
IMSS and ISSSTE (federal social-security health systems) cover leech therapy only when included in protocols of accredited hospitals; private insurance variable. Significant out-of-pocket payment is common.
Key Regulatory Documents
ASH Editorial Notes
COFEPRIS recognises FDA, EMA, Health Canada, TGA, MHLW (Japan), and Swissmedic decisions under its Reliance Pathway (introduced 2020); FDA K040187 can serve as a reliance reference, shortening registration to ~60 days.
Related Jurisdictions
FDA — United States
First regulator in the world to clear medicinal leeches as a medical device — Hirudo medicinalis cleared under K040187 (June 21 2004).
Health Canada — Canada
Regulates Hirudo medicinalis under the Medical Devices Regulations as a Class II device; mirrors FDA risk classification with bilingual labelling requirements.
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.