What to Do When a Medical Device Establishment Licence (MDEL) is Suspended or Cancelled – Health Canada Guidance

Reasons for Suspension or Cancellation

Health Canada may suspend or cancel an MDEL under section 21.31 of the Food and Drugs Act and sections 46–47 of the Medical Devices Regulations for reasons including:

• Non-compliance with the Medical Devices Regulations or conditions of the licence.
• Failure to maintain an adequate quality management system.
• Providing false or misleading information in the application or during inspections.
• Failure to pay renewal fees or submit required notifications.
• Immediate or significant risk to health or safety posed by the establishment’s activities.

Suspension is typically used for serious but remediable issues; cancellation occurs when compliance cannot be achieved or risks are severe. What to Do if Your MDEL is Suspended or Cancelled - Canada.ca

Immediate Actions Required

Upon receiving notice of suspension or cancellation:

• Cease all regulated activities (importing, distributing, selling, or manufacturing Class II, III, and IV devices) immediately.
• Stop any further shipments or transfers of affected devices.
• Notify all customers, consignees, and suppliers in writing of the licence status and instruct them to stop using or distributing affected devices.
• Quarantine any remaining inventory of Class II–IV devices in your possession to prevent further distribution.

Inventory Management and Recall

• Identify and segregate all affected devices in your control.
• Initiate a recall if devices have been distributed and pose a risk, following mandatory recall procedures.
• For suspended licences, devices may be released after remediation and Health Canada approval.
• For cancelled licences, devices generally cannot be further distributed in Canada; coordinate return, disposal, or destruction as directed.
• Maintain detailed records of all actions taken regarding inventory and notifications.

Communication and Cooperation

• Respond fully and promptly to any Health Canada requests for information, corrective action plans, or evidence of remediation.
• Submit a detailed corrective and preventive action (CAPA) plan if required to address the non-compliance.
• Cooperate during any follow-up inspections or audits.

Reapplication or Reinstatement

• After suspension: Once non-compliance is corrected, submit evidence to Health Canada for review and potential reinstatement.
• After cancellation: A new MDEL application must be submitted; previous non-compliance will be considered during review.
• Reinstatement or new issuance is not guaranteed and may require additional scrutiny.

Consequences of Non-Compliance

• Continued regulated activities after suspension/cancellation may lead to seizure of devices, administrative monetary penalties, or prosecution.
• Failure to notify customers or manage inventory properly can result in additional enforcement measures.

Practical Recommendations

• Develop and maintain a contingency plan for licence suspension/cancellation scenarios.
• Keep up-to-date contact lists for customers and suppliers.
• Document all communications and actions taken in response to a suspension or cancellation notice.
• Seek legal or regulatory advice if needed to understand obligations and next steps.

This guidance outlines the critical steps establishments must take to protect public health and comply with regulatory requirements following suspension or cancellation of an MDEL. Full details, including timelines, notification templates, recall procedures, and contact information, are available in the official Health Canada guidance document. What to Do if Your MDEL is Suspended or Cancelled - Canada.ca