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Draft guidance on how to interpret ‘significant change’ of a medical device: Overview - Canada.ca
18 avr. 2025
legacy-hc-2025-04-21
ID 168445
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Draft guidance on how to interpret ‘significant change’ of a medical device: Overview - Canada.ca
2 janv. 2026
hc-20260101
ID 428997
updated2 sections changed
2 sections modifiées0 ajoutées0 retirées+1 / -2 lignesVariation: 2%
--- +++ @@ -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. Page details-Date modified: 2024-02-07