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Significant Change Assessment
Health Canada MDL Amendments & Significant Changes
A Health Canada licence must remain aligned with the device that is actually manufactured and sold. Certain changes to Class II, III and IV devices require a new or amended MDL, while other changes may be documented internally or handled through a different regulatory mechanism.
Changes We Assess
Intended use, indications, or contraindication expansions
Design and functional performance modifications
Material, chemical formulation, or biocompatibility changes
Software algorithms, architecture, and cybersecurity updates
Manufacturing site relocations, additions, or process alterations
Critical supplier or subcontractor substitutions
Sterilization method, cycle parameters, or contract sterilizer changes
Primary/secondary packaging and shelf-life / expiry extensions
Labelling, IFU, and marketing claim adjustments
Device family, group, or catalogue identifier additions
Changes to model numbers or device configurations
Private label licence amendments and notifications
Our Lifecycle Assessment Logic
1
Determine whether the change affects safety, effectiveness, or licensed indications.2
Determine whether the change qualifies as a Significant Change under Health Canada policy.3
Identify required verification, validation, and pre-clinical testing evidence.4
Assess whether additional clinical or performance data is required.5
Assess impact on risk management documentation (ISO 14971) and labelling.6
Assess MDSAP and QMS documentation impact.7
Determine whether an amendment application, minor-change filing, or annual update is appropriate.8
Update the technical dossier, REP metadata, and regulatory records.Expert Focus:
The question is not simply “Did the device change?” It is “Does the change alter the basis on which Health Canada accepted the device’s safety, effectiveness, quality or licensed indications?”
Manage Health Canada Licence Amendments and Lifecycle Changes
Our regulatory strategists determine amendment triggers, compile change justifications, and update technical files.