Autoridade Nacional do Medicamento e Produtos de Saúde — Infarmed
Infarmed · Portugal · europe
Portugal's national medicines and health products authority — applies EU MDR for medical devices; leech-specific regulation has not been independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Portugal
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.infarmed.pt
Relevant Regulation Codes
- Decreto-Lei n.º 145/2009 (Portuguese medical devices legislation, as amended)
- Regulation (EU) 2017/745 (MDR) — direct effect
Prescriber Requirements
- Ordem dos Médicos-registered MD prescription required
- Non-physician practitioner scope (e.g., terapêutas não convencionais under Lei n.º 71/2013) for hirudotherapy not independently verified by ASH
Supply Chain & GMP
EU MDR-aligned registration with Infarmed; Portuguese-language IFU; cold chain per manufacturer specifications.
Import/Export Rules
Intra-EU free movement. Third-country imports via Infarmed notification and standard CITES Appendix II paperwork plus DGAV (Direção-Geral de Alimentação e Veterinária) live-invertebrate clearance.
Reimbursement Context
SNS (Serviço Nacional de Saúde) covers inpatient flap-salvage indications via hospital DRG bundling; specific outpatient hirudotherapy reimbursement status not independently verified by ASH.
Key Regulatory Documents
ASH Editorial Notes
Portugal recognises non-conventional therapies under Lei n.º 71/2013 (acupuncture, homeopathy, naturopathy, osteopathy, phytotherapy, chiropractic, traditional Chinese medicine) but hirudotherapy is not on the recognised list; specific regulatory practice has not been independently verified by ASH.
Related Jurisdictions
EMA — European Union
Centralised EU authority for medicinal products — leeches sit on the border between MDR-regulated device and HMPC traditional herbal medicine framework.
European Commission — European Union
EU executive body responsible for the Medical Device Regulation (MDR) — the legal instrument that frames how Member States CE-mark leech products.
MHRA — United Kingdom
Post-Brexit UK regulator — accepts EU CE marks during transition, with UKCA marking now phased in for Great Britain (Northern Ireland follows EU MDR via Windsor Framework).
BfArM — Germany
Germany classifies medicinal leeches as a finished medicinal product (Fertigarzneimittel) — uniquely strict among EU Member States and requires marketing authorisation via BfArM.