Swissmedic — Swiss Agency for Therapeutic Products
Swissmedic · Switzerland · europe
Switzerland's therapeutic-products regulator — applies MepV (Medical Devices Ordinance) closely harmonised with EU MDR, with bilateral recognition agreements covering CE-marked devices including leeches.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Switzerland
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.swissmedic.ch
Relevant Regulation Codes
- Heilmittelgesetz (HMG, SR 812.21)
- Medizinprodukteverordnung (MepV, SR 812.213)
- Bilateral Mutual Recognition Agreement (MRA) EU–CH (medical devices)
Prescriber Requirements
- Physician (Arzt) prescription required; cantonal medical chambers control scope
- Naturheilpraktiker with federal diploma (Bundesdiplom Naturheilpraktiker/in mit eidg. Diplom, since 2016) have explicit scope to use leech therapy
- Hospital-based application by nursing staff under standing order
Supply Chain & GMP
Distributor must register with Swissmedic and notify the Swiss Authorised Representative (CH-REP). CE certificate accepted under EU–CH MRA. Trilingual DE/FR/IT labelling under HMG art. 17.
Import/Export Rules
Imports from EU under MRA flow without additional certification beyond CH-REP designation. Third-country imports require Swissmedic notification. CITES processed by BLV (Federal Food Safety and Veterinary Office).
Reimbursement Context
Krankenpflege-Leistungsverordnung (KLV) covers complementary medicine including hirudotherapy when performed by a physician with relevant Fähigkeitsausweis (FMH) since 2017 — Switzerland is the only country with constitutional protection of complementary medicine via 2009 referendum (Art. 118a BV).
Key Regulatory Documents
ASH Editorial Notes
Switzerland's constitutional inclusion of complementary medicine makes it one of the most leech-therapy-friendly Western jurisdictions; statutory health insurance (OKP) reimburses leech therapy delivered by FMH-credentialed physicians.
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.