Other Regulatory Requirements for Medical Device Establishment Licence Holders – Health Canada Guidance

Overview of Additional Obligations

While the Medical Device Establishment Licence (MDEL) primarily addresses quality management and operational controls, holders of MDELs for Class II, III, and IV medical devices are subject to several other key regulatory obligations under the Food and Drugs Act and Medical Devices Regulations. These requirements ensure device safety, effective post-market surveillance, and proper market conduct throughout the device lifecycle. Other Regulatory Requirements - Canada.ca

Mandatory Problem Reporting

MDEL holders must report incidents involving medical devices to Health Canada as required under sections 59–61 of the Medical Devices Regulations:

• Report serious injuries, deaths, or recalls within 10 days (or sooner for life-threatening situations).
• Submit preliminary and final reports detailing the incident, root cause analysis, and corrective actions.
• Maintain records of all reported incidents and follow-up actions.

Failure to report timely can result in enforcement measures.

Recall Procedures

Holders must have effective recall procedures in place:

• Initiate voluntary or mandatory recalls when a device presents a risk to health.
• Notify Health Canada, customers, and consignees promptly.
• Provide recall strategy, effectiveness checks, and final status reports.
• Cooperate fully during Health Canada-monitored recalls.

Advertising and Promotion Restrictions

Advertising of Class II, III, and IV devices is regulated:

• Claims must be supported by evidence and consistent with the licensed intended use.
• Prohibited from making false, misleading, or deceptive statements.
• Certain high-risk claims require pre-clearance or specific substantiation.
• Advertising must not imply devices are approved for unapproved uses.

Labelling and Packaging Compliance

MDEL holders must ensure devices in their control meet labelling requirements:

• Labels must include device identifier, manufacturer details, intended use, warnings, and instructions.
• Changes to labelling require notification if they affect safety or performance.
• Imported devices must comply with Canadian labelling standards upon entry.

Inspections and Enforcement Cooperation

Holders must:

• Allow Health Canada inspectors access to premises, records, and personnel.
• Provide samples and documentation upon request.
• Implement corrective and preventive actions (CAPA) in response to inspection observations.
• Be subject to compliance verification, for-cause inspections, or audits.

Non-compliance may lead to administrative monetary penalties, licence suspension/cancellation, product seizure, or prosecution.

Practical Considerations

• Integrate these obligations into the quality management system for efficiency.
• Train staff on reporting, recall, and advertising rules.
• Maintain up-to-date contact lists for rapid notification during recalls.
• Monitor Health Canada advisories and regulatory updates regularly.

These additional requirements complement the MDEL framework and are essential for protecting public health and maintaining regulatory compliance. Detailed explanations, timelines, forms, and references to specific sections of the regulations are provided in the official Health Canada guidance on other regulatory requirements for MDEL holders. Other Regulatory Requirements - Canada.ca