All terms
Health Canada Medical Device Licence
Authorization required to import or sell Class II, III, or IV medical devices in Canada.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Health Canada's Medical Devices Bureau issues MDLs under the Medical Devices Regulations (SOR/98-282). Class I devices require an MDEL (Medical Device Establishment Licence) instead.What this means in practice
Canada was the first MDSAP-mandatory country: a current MDSAP certificate from an Auditing Organization is required to obtain or maintain an MDL for Class II–IV devices.Cross-references
Uses
Concepts or artefacts this term builds on.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
Health Canada·1RAPS·1FDA·1
- 1
Medical Devices RegulationsVerifiedHealth Canadalaws-lois.justice.gc.ca
- 2
RAPS Regulatory FocusVerifiedRAPSraps.org
- 3
FDA - Medical DevicesVerifiedFDAfda.gov
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