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)

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

• a new policy on medical device establishment licence terms and conditions
• revisions to the guidance on medical device establishment licensing (GUI-0016)
• revisions to the medical device establishment licence application (FRM-0292) and its instructions

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:

• 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

Key changes

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

Some of these changes include:

• new authorities for the Minister to impose terms and conditions on a medical device establishment licence
• increased oversight of establishment name changes

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:

• terms and conditions policy
• guidance on medical device establishment licensing (GUI-0016)
• medical device establishment licence application form (FRM-0292)

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

• Current published version of GUI-0016:
  Guidance on Medical Device Establishment Licensing (GUI-0016): Summary
• Current published version of FRM-0292:
  Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292)

Contact us

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