Share your views: Draft guidance on how to interpret ‘significant change’ of a medical device
Current status: Closed
This consultation ran from February 7, 2024, to April 22, 2024.
This guidance:
- helps manufacturers determine when a change made to a device is significant
- explains the concepts that manufacturers must apply when making this determination
- provides many examples to help delineate the types of changes that are significant
Who was the focus of this consultation
We engaged with medical device stakeholders, including:
- manufacturers of Class II to IV medical devices
- regulatory representatives
Key questions for discussion
Health Canada asked for feedback on the overall clarity and content of the draft guidance.
We also asked the following questions:
- Is the document clear and comprehensible? Is there a need to clarify any of the concepts or principles presented in the document?
- Are there any concepts or principles missing from the document? If yes, please identify and explain.
- Are there any types of changes that could be made to a medical device that are missing from the document? If so, what are the types of changes that could be made to a medical device that need to be discussed?
We used the comments we receive to finalize the guidance document.
Related information
Contact us
Medical Devices Directorate
Health Products and Food Branch
Health Canada
11 Holland Ave, Tower A
Address Locator: 3002A
Ottawa ON K1A 0K9
Email: mddpolicy-politiquesdim@hc-sc.gc.ca