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. An MDL is needed for Class II, III and IV devices before sale in Canada; the Class I MDEL is held by the importer or distributor rather than the manufacturer. Applications for Class II to IV require an ISO 13485 quality management system certificate issued through the Medical Device Single Audit Program (MDSAP).

Why it matters

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.

Common pitfalls

•A common misconception is that an MDL applies to all device classes; however, Class I devices instead require a Medical Device Establishment Licence (MDEL).
•Failing to maintain a current MDSAP certificate can lead to suspension or revocation of an MDL for Class II, III, and IV devices.
•Applying for an MDL without first ensuring compliance with all pre-market requirements, including quality management system certification if applicable, can cause significant delays.
•Not understanding the specific class of your device can lead to applying for the wrong type of licence (MDL versus MDEL).

Sources

Medical Devices Regulations · Health Canada
RAPS Regulatory Focus · RAPS
FDA - Medical Devices · FDA

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