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Amending a Device Licence

When is an amendment required?​

A Device Licence amendment is required when a change to the device could affect its safety, effectiveness, or labelling. Health Canada must be notified of these changes before the modified device is sold in Canada.

Changes that typically require an amendment:​

  • Changes to the intended use or indications for use
  • Design changes that affect safety or performance (e.g., change of a critical component, change of materials of construction)
  • Changes to manufacturing process that could affect product quality (e.g., change of sterilisation method)
  • Software updates that materially change clinical output (see SaMD)
  • Labelling changes — adding/removing indications, changing warnings, adding new contraindications
  • Changes to the shelf life of the device
  • Changes to the sterility status of the device

Changes that typically do NOT require an amendment:​

  • Administrative corrections to labelling (e.g., correcting a phone number, updating a distributor address)
  • Minor software updates that do not affect clinical function (bug fixes, security patches)
  • Changes to packaging that do not affect sterility, shelf life, or labelling content

When in doubt, contact Health Canada's Medical Devices Directorate for guidance before implementing a change.

How to submit an amendment​

Amendment applications are submitted via the Health Canada e-Submission portal (HRES), using the same process as original Device Licence applications, but clearly identified as an amendment.

The amendment application must:

  • Reference the original Device Licence number
  • Describe the nature of the change
  • Provide evidence that the change does not adversely affect safety or effectiveness (or that safety and effectiveness are maintained or improved)
  • Include updated labelling if labelling has changed

Fees for amendments​

Amendment applications are subject to fees. The applicable fee depends on the significance of the change. Minor amendments (administrative) may attract lower fees than significant changes.

Legislative source: Medical Devices Regulations, SOR/98-282, ss 34–38 (amendments)