Health Canada begins canceling MDEL licenses for failure to comply with annual review
Health Canada has begun the automatic cancellation of Medical Device Establishment Licenses (MDEL) for operators who failed to meet the mandatory annual review requirements. This measure, already in effect in 2025, directly impacts distributors, importers, and establishments that market medical devices in Canada.
The annual MDEL review is mandatory and includes:
Confirmation of compliance with regulatory requirements
Updating company information
Payment of the annual maintenance fee
Failure to meet any of these obligations results in immediate license revocation, with no grace period or prior notice.
Consequences of Cancellation
Revocation of the MDEL prevents the operator from legally continuing their activities in the Canadian market. Additionally:
A complete new application is required to reactivate the license
There is a risk of disruption in supply chains and direct commercial impact
Products imported by operators with revoked licenses may be held at the border
How Smart MDR Can Support Your Company
At Smart MDR, we assist companies in proactively managing compliance in Canada, including:
Submission and follow-up of the annual MDEL review
Technical and documentation updates with Health Canada
Regularization and resubmission of canceled licenses
Monitoring of critical regulatory deadlines
If you are a distributor, importer, or partner of manufacturers operating in Canada, ensure your license remains valid.
Be Smart. Be Compliant.
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