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Draft guidance on how to interpret ‘significant change’ of a medical device: Overview - Canada.ca

Apr 18, 2025

legacy-hc-2025-04-21

ID 168445

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Later capture

Draft guidance on how to interpret ‘significant change’ of a medical device: Overview - Canada.ca

Jan 2, 2026

hc-20260101

ID 428997

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updated2 sections changed
2 sections changed0 added0 removed+1 / -2 linesChange ratio: 2%
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@@ -33,7 +33,7 @@
changing 1 or more component parts in cases where the medical device is authorized as a system, test kit, group, family or group family
It may be useful to compare the proposed changes side by side with the current authorized device.
To determine how your proposed change(s) to a device may impact the structure of a current authorization, you should consult:
-Guidance for the interpretation of sections 28 to 31: Licence application type
+Guidance for determining medical device application type
In some cases, you may have to file a new application for an authorization rather than apply for an amendment.
A modification to a device may involve changes to its design, function, safety, manufacturing, packaging, finishing or labelling. Thus, it is not feasible to outline all the possible changes that could be made to a device. If you have outstanding questions about a particular change, please contact the Medical Devices Directorate by email:
meddevices-instrumentsmed@hc-sc.gc.ca
@@ -58,5 +58,4 @@
page.
You must document all changes in your quality management system. If changes are not significant as outlined in this guidance but concern the information and/or documents you originally submitted with your medical device application, you must report these changes to Health Canada at the time of annual renewal. We suggest that you itemize these changes in a table and provide a brief rationale describing why the change is not significant.
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-Date modified:
2024-02-07