Share your views: Consultation for medical devices recall guide (GUI-0054)

Current status: Open

Opened on February 9, 2024, and will close to new input on March 9, 2024.

Health Canada has drafted revisions to the Guide to Recall of Medical Devices (GUI-0054) to increase predictability and transparency for industry, The revised guidance contains new information on recall requirements.

Join in: how to participate

Email us to request the consultation package and submit your comments by March 9, 2024.


Who is the focus of this consultation

We will engage with:

Key changes

We made changes in several sections to enhance clarity and to reflect improved practices. Examples include:

We'll consider the input gathered through this process in the final publication of GUI-0054. Note that the service standards and timelines provided in the consultation document are not final and are subject to change before we publish the final guidance.

Related information

Contact us

Medical Device Compliance Program
Medical Device and Clinical Compliance Directorate

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