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January 10, 2026
Approximately 5 minutes
Notice to Industry: Licensing Requirements for Medical Devices in Canada
Notice to Industry: Licensing Requirements for Medical Devices in Canada
Overview and Regulatory Requirement
Under the Medical Devices Regulations, most medical devices intended to be sold or imported into Canada must hold a valid medical device licence issued by Health Canada before they can be marketed or distributed. This requirement applies to Class II, III, and IV devices; Class I devices are generally exempt from licensing but must comply with other regulatory obligations such as labelling, quality systems, and adverse event reporting. The licensing process ensures that devices meet Canadian standards for safety and effectiveness. Source: Notice to Industry: Licensing Requirements for Medical Devices - Canada.ca
Device Classification and Licence Applicability
Medical devices are classified into four risk-based classes:
- Class I: Lowest risk (e.g., bandages, manual surgical instruments) — no licence required
- Class II: Moderate risk (e.g., contact lenses, syringes) — licence required
- Class III: Higher risk (e.g., pacemakers, hip implants) — licence required
- Class IV: Highest risk (e.g., heart valves, implantable defibrillators) — licence required
Manufacturers, importers, and distributors must confirm the classification of their device using Health Canada’s classification rules before determining licensing needs.
Licensing Application Process
- Submit applications electronically via the Medical Devices Bureau portal.
- Provide comprehensive technical documentation demonstrating compliance with safety and performance requirements.
- Include quality management system evidence (ISO 13485 certification for higher classes).
- Pay applicable fees based on device class and application type.
- Health Canada reviews applications within statutory timelines (typically 15–90 days depending on class).
Key Compliance Expectations
- Devices must be labelled in English and French with required information (manufacturer details, intended use, warnings, etc.).
- Post-market obligations include mandatory problem reporting, recalls, and ongoing surveillance.
- Changes to licensed devices (design, labelling, intended use) may require amendment applications or new licences.
- Failure to hold a required licence can result in enforcement actions, including product seizure or prohibition of sale.
Practical Guidance for Industry
- Use Health Canada’s guidance documents and classification tools to determine requirements early.
- Engage in pre-submission consultations for complex or novel devices.
- Maintain accurate records of classification rationale and licensing status.
- Monitor regulatory updates, as requirements may evolve with new notices or amendments.
This notice reinforces the importance of obtaining appropriate licensing prior to any commercial activity involving higher-risk medical devices in Canada. Detailed application forms, fee schedules, classification guidance, and examples of common compliance issues are available in the official Health Canada notice to industry on medical device licensing requirements. Source: Notice to Industry: Licensing Requirements for Medical Devices - Canada.ca
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