Share your views: Draft guidance on how to interpret ‘significant change’ of a medical device

From Health Canada

Current status: Open

Opened on February 7, 2024, and will close to new input on April 22, 2024.

Health Canada has updated the Guidance on how to interpret ‘significant change’ of a medical device.

This guidance:

Join in: how to participate

Send an email to with your ideas or comments to make yourself heard.

Who is the focus of this consultation

We seek to engage with medical device stakeholders, including:

Key questions for discussion

Health Canada invites you to provide feedback on the overall clarity and content of the draft guidance.

We also would like you to answer the following questions:

We will use 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

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