In a significant step toward global regulatory alignment, Health Canada has announced it is adopting the International Medical Device Regulators Forum (IMDRF) table of contents format for medical device applications. This move is aimed at fostering global harmonization and facilitating clearer, more consistent regulatory submissions for medical device manufacturers and stakeholders.
What changed?
Health Canada has formally adopted the IMDRF table of contents format for structuring medical device applications. This change, announced on November 26, 2025, aims to align Canada’s regulatory review process with international best practices. The new framework is intended to improve clarity and predictability for both manufacturers and regulators by standardizing how applications are organized and presented.
The IMDRF framework is widely recognized among international regulatory bodies. By implementing this structure, Health Canada joins other jurisdictions that have embraced the international approach, promoting ease of submissions and reducing redundancies in the regulatory process.
Who is affected?
This update impacts medical device manufacturers, clinical teams, and regulatory affairs professionals involved in preparing or submitting applications to Health Canada. Companies already familiar with the IMDRF format used in other countries may find adaptation seamless, while others may require updates to their internal documentation processes.
The change may also affect clinical trial sponsors and quality assurance teams striving to comply with Canada’s regulatory landscape. Stakeholders are encouraged to review the updated guidelines to ensure compliance and full understanding of the new submission requirements.
Benefits of the IMDRF format
Health Canada’s adoption of this format introduces several advantages:
- Global consistency: Aligns with international standards, reducing the burden for manufacturers operating in multiple jurisdictions.
- Streamlined reviews: Enables more efficient regulatory assessments by presenting standardized and well-organized data sets to Health Canada reviewers.
- Enhanced transparency: Applicants can better understand submission expectations and increase approval predictability.
These benefits also extend to global device approval strategies, supporting faster access to life-saving technologies and harmonized regulatory practices.
FAQ
What is the IMDRF table of contents format?
The IMDRF table of contents format is a standardized framework designed to organize submission documents for medical device regulatory applications. It ensures consistent structure across jurisdictions.
Does this apply to all types of medical devices?
Yes, the IMDRF format is applicable across medical device classifications but may have specific requirements depending on the risk class of the device.
When do these changes take effect?
The adoption has been announced, but stakeholders should monitor Health Canada’s official communications for detailed timelines and transitional guidance.
Conclusion
Health Canada’s alignment with the IMDRF table of contents format marks an important step in modernizing its regulatory approach to medical devices. Stakeholders, including manufacturers, clinical teams, and regulatory professionals, are encouraged to familiarize themselves with the new requirements to remain compliant and ensure smooth submission processes. This change supports a more globalized, transparent, and efficient regulatory framework.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or regulatory advice. Medical device manufacturers should consult with appropriate legal experts for specific guidance on compliance.
Health Canada announcement link
For full information about the announcement, see the link below.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/international-medical-device-regulators-forum.html