Share your views: Draft policy on terms and conditions for medical device establishment licences, guidance on medical device establishment licensing (GUI-0016), and medical device establishment licence application (FRM-0292)

Current status: Open

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

To increase predictability and transparency for industry, Health Canada has drafted:

The revised documents contain new information on the use of terms and conditions on medical device establishment licences and their application requirements.

Join in: how to participate

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

Email: meddev-matmed@hc-sc.gc.ca

Who is the focus of this consultation

We will engage with:

Key changes

We made changes to introduce new regulatory requirements and to reflect improved practices.

Some of these changes include:

We also edited and formatted the medical device establishment licence application form to reflect these changes.

We'll consider the input gathered through this process in the final publication of the:

The content changes provided in the document for consultation are not final and are subject to change before we publish the final guidance.

Related information

Contact us

Medical Devices Compliance Program
Medical Devices and Clinical Compliance Directorate
Email: meddev-matmed@hc-sc.gc.ca

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