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:
- Canadian medical device establishment licence (MDEL) holders
- Canadian medical device licence (MDL) holders
- Canadian groups or associations that represent MDEL and MDL holders
- members of the public interested in medical device regulation
We made changes in several sections to enhance clarity and to reflect improved practices. Examples include:
- updates to the regulatory definition of "recall"
- reporting requirements and timelines
- record keeping requirements
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.
- Current published version of GUI-0054:
Guide to Recall of Medical Devices (GUI-0054) - Canada.ca
Medical Device Compliance Program
Medical Device and Clinical Compliance Directorate
- Date modified: