Agência Nacional de Vigilância Sanitária
ANVISA · Brazil · latin america
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.
Regulatory Profile
- Agency type
- national regulator
- Region
- latin america
- Country
- Brazil
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.gov.br/anvisa
Relevant Regulation Codes
- Lei nº 9.782/1999 — cria a ANVISA
- Lei nº 6.360/1976 — vigilância sanitária a que ficam sujeitos os medicamentos
- RDC nº 751/2022 — classificação de risco e regularização de dispositivos médicos
- Política Nacional de Práticas Integrativas e Complementares no SUS — PNPIC (Portaria 971/2006)
Prescriber Requirements
- CRM-registered médico prescription required
- Enfermeiro/a (RN) application under physician's order; complementary-practice diplomas accredited via Ministério da Saúde / SUS
- Hirudoterapia explicitly listed among PICS modalities under Portaria 971/2006
Supply Chain & GMP
ANVISA device registration (Cadastro / Registro) per RDC 751/2022; AFE (Autorização de Funcionamento da Empresa) for distributors. Portuguese-language labelling mandatory.
Import/Export Rules
Import via VICOMEX system + Ministério da Agricultura, Pecuária e Abastecimento (MAPA) clearance for live invertebrates. CITES via IBAMA.
Reimbursement Context
SUS (Sistema Único de Saúde) covers hirudoterapia in some municipalities under PNPIC implementation — São Paulo, Rio de Janeiro, and several Northeast capitals have funded programmes. Private insurance (saúde suplementar) variable.
Key Regulatory Documents
ASH Editorial Notes
Brazil is Latin America's leading hirudotherapy jurisdiction — PNPIC policy puts the country in a small group (with Switzerland and Russia) that explicitly funds leech therapy as a complementary public-health service.
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.
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.