Understand the Recent Updates to Health Canada's Medical Device Significant Change Guidance Document and it's Impact on your QMS

Were you aware that Health Canada recently published a new guidance document on Medical Devices Significant Change as of March 31, 2026?

Health Canada Significant Change Update

Who does this Medical Device Significant Changes affect?

The scope of this guidance document remains consistent, primarily affecting manufacturers of Class III and IV medical devices in Canada. Nonetheless, certain Class II devices are also subject to the significant change requirements if:

1. Class II devices intended to be used with a separate licensed Class III and IV medical device AND

2. The change may impact safety and efficacy when all components are used together.

This guidance on significant changes does not apply to the following:

1. Class II devices that doesn't meet the definition above

2. Devices classified under the Urgent Public Health Need as per Part 1.1. of the CMDR

3. Hybrid drug-medical devices

What changed significantly?

Better definition with examples!

A key revision in this guidance document is the enhanced clarity in defining what constitutes as a significant change, is now accompanied by examples. While the definition of a significant change remains consistent with Section 34 of the CMDR, the previous flow charts have been replaced by tables that outline scenarios indicating whether a change is deemed significant.

Software and AI requirements

Significant changes to SaMD now includes consideration of machine learning medical

devices (MLMD) also known as AI. In addition, Health Canada has adopted the requirements of a Predetermined Change Control Plan (PCCP) as introduced by the FDA.

Diagnostic UltraSound

The updated guidance document includes a dedicated section that defines what constitutes a significant change for diagnostic ultrasound machines. Given the longstanding history and well-established safety profile of these machines, Health Canada does not regard a change as significant unless all the criteria outlined in the guidance document are fulfilled.

In conclusion, the recent changes to the guidance from Health Canada is a great amalgamation of US FDA and AU TGAs' requirements. Great step towards harmonization!

How A. Quality | Regulatory Can Help

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