2024 Annual Review of Medical Device Establishment Licences – Health Canada Summary

Overview of the 2024 Annual Review

Health Canada conducts an annual review of all active Medical Device Establishment Licences (MDELs) to assess ongoing compliance with the Food and Drugs Act and Medical Devices Regulations. The 2024 review covered more than 2,800 licences held by importers, distributors, and manufacturers of Class II, III, and IV medical devices. The process helps identify systemic compliance issues, verify that licence holders maintain required standards, and take enforcement action when necessary to safeguard patient safety and the integrity of the medical device supply chain. Annual Licence Review 2024 - Canada.ca

Key Findings and Compliance Issues

The review revealed persistent non-compliance patterns among some licence holders:

• Inadequate or incomplete record-keeping (e.g., distribution records, complaint files, quality system documentation).
• Failure to report incidents or submit mandatory problem reports in a timely manner.
• Insufficient corrective and preventive action (CAPA) implementation following inspections or complaints.
• Lack of proper quality management system controls or training.
• Non-response or inadequate response to inspection observations.

These issues indicate gaps in operational controls and vigilance obligations, potentially compromising device safety and traceability.

Enforcement Actions Taken

Health Canada applied a risk-based enforcement approach:

• Warnings and orders to correct deficiencies.
• Administrative monetary penalties for repeated or serious violations.
• Suspension of MDELs where immediate risks were identified.
• Cancellation of licences for persistent non-compliance or failure to remediate.

A number of licences were cancelled following the review, with affected establishments required to cease regulated activities involving Class II–IV devices.

Risk-Based Prioritization

Licences were prioritized for detailed review based on:

• Previous compliance history.
• Volume and risk class of devices handled.
• Nature of any prior enforcement actions.
• Signals from post-market surveillance or incident reports.

This targeted approach ensures resources focus on higher-risk establishments.

Recommendations for Licence Holders

To maintain compliance and avoid enforcement action, MDEL holders are urged to:

• Conduct regular internal audits of quality systems and records.
• Ensure timely and complete incident reporting via the Mandatory Problem Reporting system.
• Develop and fully implement effective CAPA plans with measurable outcomes.
• Maintain up-to-date training records for personnel.
• Respond promptly and substantively to all Health Canada requests and observations.

Proactive compliance reduces the likelihood of regulatory intervention and supports continued market access.

This annual review underscores Health Canada’s commitment to rigorous oversight of the medical device supply chain. Detailed statistics, common deficiency examples, enforcement outcomes, and compliance tips are provided in the full 2024 MDEL Annual Review bulletin on the Health Canada website. Annual Licence Review 2024 - Canada.ca