Health Canada — Therapeutic Products Directorate
Health Canada · Canada · north america
Regulates Hirudo medicinalis under the Medical Devices Regulations as a Class II device; mirrors FDA risk classification with bilingual labelling requirements.
Regulatory Profile
- Agency type
- national regulator
- Region
- north america
- Country
- Canada
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
Relevant Regulation Codes
- Food and Drugs Act (R.S.C. 1985, c. F-27)
- Medical Devices Regulations (SOR/98-282) — Class II
- MDSAP (Medical Device Single Audit Program) certification expected for manufacturer
Prescriber Requirements
- Prescription medical device — order required from a Canadian-licensed physician, NP, or dentist per provincial scope
- Application by RN under standing-order protocols in hospital settings
- Provincial colleges (e.g., CPSO, CPSA) govern delegation to allied health staff
Supply Chain & GMP
Manufacturer must hold Medical Device Establishment Licence (MDEL); importer/distributor MDEL required separately. Cold-chain 4–10 °C, dechlorinated water, monthly water exchange. Bilingual EN/FR labelling mandatory under SOR/98-282 s. 21.
Import/Export Rules
Import permits via Canadian Food Inspection Agency (CFIA) for live invertebrates; CITES Appendix II permit required for H. medicinalis. Shipments must declare device licence number; commercial entry through Canada Border Services Agency.
Reimbursement Context
Provincial health insurance (OHIP, RAMQ, MSP, AHCIP) covers leech therapy when delivered inpatient as part of bundled DRG-equivalent funding. Outpatient coverage variable — typically negotiated case-by-case for reconstructive flap salvage.
Key Regulatory Documents
ASH Editorial Notes
Canada generally accepts FDA 510(k) clearance evidence under MDSAP harmonisation, simplifying market entry for Ricarimpex products. Quebec requires French-first labelling under Charter of the French Language (Bill 96 amendments effective 2025).
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).
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.
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).
TGA — Australia
Australia's therapeutic-goods regulator — medicinal leeches included in the Australian Register of Therapeutic Goods (ARTG) as Class IIa medical device with import permit oversight.