Expectations for information submitted with Class III and IV medical device licence applications: Notice to industry
Date: 2026-07-16
On this page
- Background
- Expectations for application content
- Use of summaries and supporting evidence
- Use of artificial intelligence (AI) tools
- Contact us
Background
Health Canada has recently observed a significant increase in the volume of information submitted with Class III and IV medical device licence applications. Including large amounts of unnecessary information can delay the review process.
Expectations for application content
Submit only the information needed to support your application. This helps meet regulatory requirements and supports a timely review.
If the relevance of the information you submit is unclear, Health Canada may ask for clarification.
Including unnecessary or duplicative information can increase review times and delay the licensing process.
Use of summaries and supporting evidence
As set out in the Medical Devices Regulations, applications for Class III and IV licences must include summaries of the studies and evidence submitted.
Applicants should:
- provide clear and concise summaries
- ensure summaries accurately reflect the supporting data
- clearly identify the information required to support a timely review.
Use of artificial intelligence (AI) tools
If applicants use artificial intelligence (AI) tools to generate summaries or explanatory material, they are responsible for ensuring the content is accurate and reflects the supporting data.
Contact us
If you have questions about this notice, contact the Medical Devices Directorate at meddevices-instrumentsmed@hc-sc.gc.ca.