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January 7, 2026
Approximately 5 minutes
Maintaining a Medical Device Establishment Licence (MDEL) – Health Canada Guidance
Maintaining a Medical Device Establishment Licence (MDEL) – Health Canada Guidance
Purpose of Ongoing Compliance
Once issued, a Medical Device Establishment Licence (MDEL) is valid indefinitely but requires continuous compliance with the Medical Devices Regulations. Holders must maintain quality management systems, report changes, renew annually, and be prepared for inspections to ensure devices remain safe, effective, and properly controlled throughout the supply chain. Failure to maintain compliance can result in suspension, cancellation, or other enforcement actions. How to Maintain an MDEL - Canada.ca
Annual Licence Renewal
- Requirement: Submit a renewal application and pay the annual fee before the licence anniversary date.
- Process: Use the Medical Devices Online portal; confirm no major changes or provide details if changes occurred.
- Consequence of Non-Renewal: The licence becomes inactive, prohibiting regulated activities until renewed or reissued.
Notification of Changes
Holders must notify Health Canada within 30 days of significant changes, including:
- Business name, address, or contact information.
- Addition or removal of regulated activities or device classes.
- Changes to quality management system procedures.
- New foreign manufacturers or sites (for importers).
- Ownership or corporate structure changes.
Use the amendment application in the portal; minor administrative changes may require only notification.
Maintaining Quality Management System
- Keep procedures current and effective for purchasing, storage, distribution, complaint handling, mandatory problem reporting, and recalls.
- Conduct regular internal audits and training.
- Maintain quality agreements with foreign manufacturers (importers).
- Ensure ongoing verification of foreign site GMP compliance.
Record-Keeping Obligations
- Retain all required records (distribution, complaints, incidents, quality system) for at least two years, or device lifetime plus two years for implantable devices.
- Records must be readily available for inspection and demonstrate compliance.
Incident Reporting and Recalls
- Report mandatory incidents (serious injuries, deaths, recalls) within required timelines via the Medical Device Problem Report form.
- Implement effective recall procedures and notify Health Canada promptly.
- Cooperate fully during recall monitoring.
Inspections and Audits
- Be prepared for routine or for-cause inspections by Health Canada inspectors.
- Provide access to premises, records, personnel, and samples.
- Address any observations with corrective and preventive actions (CAPA) within specified timelines.
Licence Suspension or Cancellation
Grounds include:
- Failure to renew or pay fees.
- Non-compliance with regulations or quality system deficiencies.
- Providing false information.
- Immediate health or safety risks.
Suspended or cancelled holders must cease regulated activities and may need to recall devices or quarantine inventory.
Practical Tips for Compliance
- Establish a compliance calendar for renewals and notifications.
- Document all changes and maintain audit trails.
- Train staff regularly on regulatory obligations.
- Conduct mock recalls and internal audits periodically.
- Monitor Health Canada updates and guidance revisions.
This guidance helps MDEL holders understand and fulfil ongoing obligations, supporting sustained public health protection and regulatory compliance in Canada. Detailed procedures, timelines, forms, and contact information are provided in the official Health Canada MDEL maintenance guidance. How to Maintain an MDEL - Canada.ca
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