Cancellation of Medical Device Establishment Licences for Non-Compliance – Health Canada Bulletin

Legal Authority and Purpose

Under section 21.31 of the Food and Drugs Act and sections 46 and 47 of the Medical Devices Regulations, Health Canada has the authority to suspend or cancel a Medical Device Establishment Licence (MDEL) if the licence holder fails to comply with regulatory requirements. The primary purpose is to protect public health by removing non-compliant establishments from the supply chain when deficiencies pose risks or indicate systemic failures. Cancellation of MDELs for Non-Compliance - Canada.ca

Grounds for Cancellation

Health Canada may initiate cancellation proceedings for:

• Serious or repeated violations of the Food and Drugs Act or Medical Devices Regulations.
• Failure to maintain required records, quality systems, or distribution controls.
• Non-reporting or inadequate reporting of incidents, complaints, or recalls.
• Refusal or inability to implement effective corrective and preventive actions (CAPA).
• Providing false or misleading information during inspections or licence applications.
• Operating in a manner that creates an immediate or significant risk to health.

Cancellation is typically considered when suspension and/or other enforcement tools (e.g., monetary penalties, voluntary withdrawal) are insufficient or have failed to achieve compliance.

Process and Procedural Fairness

Health Canada follows these steps:

1. Identification of non-compliance – Through inspection, compliance verification, or other monitoring.
2. Notice of Intent to Cancel – Written notice detailing the grounds, evidence, and proposed action.
3. Opportunity to Respond – Licence holder is given 30 days (or specified period) to submit written representations, including evidence of compliance or proposed remediation.
4. Decision – Health Canada reviews the response and decides whether to proceed with cancellation, impose conditions, or close the file.
5. Immediate Suspension (if applicable) – In urgent cases involving imminent health risk, suspension may occur without prior notice, followed by cancellation proceedings.

Decisions are communicated in writing with reasons.

Consequences of Cancellation

• The establishment may no longer import, distribute, or sell Class II, III, or IV medical devices in Canada.
• Existing inventory may need to be quarantined, recalled, or disposed of under Health Canada direction.
• The former licence holder may face restrictions on future applications or additional scrutiny.
• Health Canada may publish the cancellation on its website or notify stakeholders.

Preventive Measures for Licence Holders

To avoid cancellation, MDEL holders should:

• Maintain robust quality management systems compliant with regulations.
• Conduct regular internal audits and promptly address findings.
• Ensure timely and complete incident reporting and recall management.
• Respond fully and cooperatively to inspection observations and requests.
• Implement sustainable CAPA plans with verifiable effectiveness.

This bulletin reinforces Health Canada’s commitment to rigorous enforcement while providing transparency on the cancellation process. Detailed procedures, examples of non-compliance triggers, and appeal options are outlined in the full compliance bulletin on the Health Canada website. Cancellation of MDELs for Non-Compliance - Canada.ca