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January 10, 2026
Approximately 5 minutes
Guidance on Determining Significant Changes to Licensed Medical Devices – Health Canada Interpretation
Guidance on Determining Significant Changes to Licensed Medical Devices – Health Canada Interpretation
Purpose and Regulatory Context
This guidance assists manufacturers in determining whether a proposed change to a licensed Class II, III, or IV medical device qualifies as a ‘significant change’ under section 4 of the Medical Devices Regulations. A significant change typically requires a new medical device licence application or amendment, while non-significant changes may only need administrative notification or internal documentation. The document provides interpretation of key terms and decision trees to support consistent compliance. Source: Guidance Document: Interpretation of Significant Change – Medical Devices - Canada.ca
Definition of Significant Change
A significant change is any modification to a licensed device that could reasonably be expected to affect:
- Safety or effectiveness
- Intended use or indications
- Risk-benefit profile
Changes are evaluated holistically; even minor modifications may be significant if they impact performance or introduce new risks.
Categories of Changes and Assessment Criteria
Design and Manufacturing Changes
Significant if they:
- Alter materials, components, or critical processes affecting biocompatibility, sterility, or performance
- Modify structural integrity, energy delivery, or software algorithms impacting safety/effectiveness
- Change manufacturing site or processes without equivalent validation
Non-significant examples: minor dimensional tolerances, cosmetic updates, or validated equivalent material substitutions.
Labelling and Intended Use Changes
Significant if they:
- Expand or modify indications, contraindications, or target populations
- Alter warnings, precautions, or instructions for use that affect safe operation
- Introduce new claims not supported by existing evidence
Non-significant: minor wording clarifications or translation updates without substantive change.
Software Changes
Significant for:
- Modifications to algorithms, decision logic, or user interface affecting diagnostic/therapeutic output
- Updates introducing new functionality or altering risk controls
Non-significant: bug fixes, cybersecurity patches, or UI improvements not impacting clinical performance.
Decision-Making Process
Manufacturers should:
- Conduct a risk-based assessment per ISO 14971
- Compare the changed device against the originally licensed version
- Use Health Canada’s decision trees (provided in the guidance) for each change category
- Document rationale for the determination
If uncertain, manufacturers may submit a pre-submission inquiry or request a formal opinion.
Submission Requirements Based on Determination
- Significant change: Submit new licence application or amendment with supporting data
- Non-significant: Maintain records; notify Health Canada only if requested or for administrative updates
- Administrative changes (e.g., company name, address): Use administrative amendment process
Practical Recommendations
- Implement change control procedures integrated with risk management and QMS
- Maintain traceability between change rationale and original licence specifications
- Engage Health Canada early for novel or borderline changes
- Regularly review cumulative changes to assess combined impact
This guidance promotes consistent interpretation and helps manufacturers avoid non-compliance while facilitating timely implementation of beneficial device improvements. Detailed decision trees, examples of significant vs. non-significant changes, and submission templates are provided in the official Health Canada significant change interpretation guidance document. Source: Guidance Document: Interpretation of Significant Change – Medical Devices - Canada.ca
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