Establishment Licence (SOR/98-282)

Health Canada Medical Device Establishment Licence (MDEL)

An MDEL authorizes an establishment to conduct regulated activities involving medical devices in Canada. It commonly applies to Class I manufacturers and to importers and distributors of medical devices across all classes, subject to regulatory exemptions.

Assess Your MDEL Requirements

MDEL Is an Operational Compliance Licence

An MDEL is not simply a company registration. The establishment must have procedures and controls capable of supporting the regulated activities listed on the licence.

Determine whether the establishment requires an MDEL and which activities must be included.

Confirm establishment name, address and regulatory activity information.

Identify device classes and categories handled by the establishment.

Review procedures for distribution records and traceability.

Review complaint handling and escalation procedures.

Review mandatory problem reporting procedures.

Review recall procedures and responsibilities.

Review storage, handling and distribution controls where relevant.

Assess importer/distributor responsibilities for verifying device licensing and labelling.

Support annual licence review requirements and licence amendments/notifications.

Inspection-Readiness Perspective:

For an MDEL holder, Health Canada may look beyond the existence of procedures and examine whether the establishment can demonstrate effective implementation through records, complaint files, distribution data, recall capability and licensing controls.

Establish and Maintain Your Health Canada MDEL Licence

Our quality and compliance consultants draft standard operating procedures, prepare initial MDEL filings, and manage annual licence reviews.

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