Health Canada has recently formalized the use of the IMDRF‑aligned Table of Contents (ToC) format for medical device submissions. This shift marks a major step towards global harmonization of regulatory submissions and directly affects how device manufacturers prepare pre‑market and post‑market documentation. The new guidance impacts submissions for Class II, III, and IV devices both IVD and non‑IVD as well as private label applications, amendments, and post‑market regulatory activities.
Below, we provide a comprehensive breakdown of the guidance, its requirements, and the practical implications for manufacturers.
WHAT IS THE IMDRF TOC & WHY HEALTH CANADA ADOPTED IT
IMDRF and the Concept of ToC
- The IMDRF is an international forum aimed at harmonizing medical‑device regulation globally.
- The Table of Contents (ToC) format is a standardized structure for organizing submission dossiers specifying folder hierarchy, section titles, document sequencing, and naming conventions.
- Use of a harmonized ToC helps ensure consistency across different regulatory jurisdictions, facilitating easier review and potential global acceptance of documentation by regulators.
Health Canada’s Rationale
Health Canada adopted the IMDRF ToC format to:
- Promote regulatory harmonization with global partners.
- Reduce submission burden and simplify review for both regulators and manufacturers.
- Increase transparency, consistency, and clarity in regulatory submissions making the review process more efficient and predictable.
Who & What Is Covered under the New ToC Requirement
The ToC-based guidance by Health Canada applies to:
- Class II, III, and IV devices (both IVD and non‑IVD).
- Private-label licence applications.
- Minor change (fax-back) applications and amendments.
- Post‑market requests/responses including deficiency responses under Medical Devices Regulations.
- Post‑market surveillance, vigilance responses, and other regulatory submissions even after licence grant.
In short: most submission types for higher-risk devices and post-market lifecycle management are covered under the new ToC requirement.
KEY SUBMISSION REQUIREMENTS UNDER THE IMDRF TOC GUIDANCE
1. Mandatory Submission Structure & File Organisation
Manufacturers must adhere to a strict dossier structure:
- Use correct folder and sub‑folder names as per the ToC template.
- Follow file naming conventions and avoid overly long paths.
- Maintain file format compatibility consistent with the guidelines.
- Organize documentation logically (e.g. technical documentation, risk management, performance data, labeling, quality systems, post-market plans, etc.) as defined under ToC headings.
This means internal regulatory teams need to align their documentation and potentially reorganize archives to match the standardized ToC layout.
2. Electronic Submission via CESG / REP Encouraged
Health Canada strongly recommends using the Common Electronic Submission Gateway (CESG) via the Regulatory Enrolment Process (REP) for submissions. Benefits: secure, fast, efficient.
Alternative methods (for now) include:
- Physical media (e.g. USB, CD/DVD, hard drive) with proper labelling and virus‑scan certification.
- Email (for small submissions under size limits), zipped but not password‑protected, and structured per ToC.
Manufacturers must ensure their internal systems and submission workflows are compatible with CESG/REP or the specified physical/email formats.
3. Post‑Market Documentation & PMS Compliance
The ToC requirement is not limited to pre‑market applications. Post‑market activities — vigilance reports, periodic safety updates, post‑market surveillance (PMS) — must also follow the same structured ToC format.
This enforces that companies maintain robust and organized post‑market documentation over device lifecycle, simplifying future updates or regulatory requests.
4. Use of Templates, Examples, and Classification Matrices
To facilitate compliance, Health Canada provides supporting tools:
- Empty folder templates (for all device classes and submission types) to guide correct dossier structure.
- Sample dossiers illustrating how files should be organized and formatted.
- Classification matrices indicating which dossier sections apply for different device classes and application types.
These resources help manufacturers build compliant dossiers without reinventing the structure.
5. Confidentiality & Public Disclosure Considerations
While much of the technical, scientific, and commercial data remains confidential, basic device information submitted to Health Canada may become publicly available once a licence is granted. Manufacturers need to be aware and plan accordingly to protect proprietary information.
6. Guidance vs. Binding Requirement Flexibility with Caution
The new IMDRF ToC is a guidance from Health Canada, not a legal regulation. This provides flexibility: alternate dossier structures may be accepted, but only with prior consultation and justification. Deviating without prior agreement risks delays or rejection.
KEY DOCUMENTS AND IMDRF REGULATORY GUIDANCE FOR ADVERSE EVENT REPORTING
The IMDRF N86 FINAL:2026 guidance update on 26 February 2026 outlines key principles for accurate adverse event reporting in medical devices. Manufacturers are advised to select the most detailed terminology, ensure full definitions match the event, and include codes from all seven terminology groups. The International Medical Device Regulators Forum (IMDRF) for selecting the correct terminology when reporting adverse events related to medical devices, including in vitro diagnostics (IVDs). It provides detailed coding and term selection guidance for stakeholders like manufacturers, healthcare providers, and regulators involved in reporting adverse events.
THE 7 TERMINOLOGY GROUPS
To provide a complete overview of an event, manufacturers must use codes from these distinct sets:
Group Name | Code Prefix | Purpose |
Medical Device Problem | A | Describes the malfunction or failure observed. |
Medical Device Component | G | Identifies the specific part involved in the incident. |
Clinical Signs/Symptoms | E | Describes the symptoms of the affected person. |
Health Impact | F | Describes the consequences or required interventions. |
Type of Investigation | B | Describes the scope or methods of the investigation. |
Investigation Findings | C | Describes the actual condition or defect identified. |
Investigation Conclusion | D | Describes the root cause determined by the manufacturer. |
IMPACTS ON MANUFACTURERS ( CHALLENGES AND BENEFITS )
Benefits
- Harmonized dossier structure simplifies multi‑jurisdiction regulatory submissions, especially for global companies.
- Templates and guidelines save time, reduce errors, and improve consistency across submissions.
- Easier navigation of documentation for internal teams, auditors, and regulators reduces back-and-forth.
- Streamlined review process by Health Canada could lead to faster license approvals and regulatory clarity.
Challenges / Requirements
- Internal regulatory teams may need retraining or reorganizing to adopt the ToC structure.
- Existing dossiers may need rework to fit folder structure and naming conventions.
- Companies must ensure compatibility with CESG/REP or understand alternate submission requirements (media, email).
- For post-market submissions, maintenance of structured PMS dossiers becomes mandatory.
- Confidential data management must be balanced with transparency requirements under public disclosure rules.
RECOMMENDED ACTIONS FOR MANUFACTURERS
If you are a medical‑device manufacturer planning to submit to Health Canada, consider the following immediate steps:
- Review internal document management processes and map existing documentation to the IMDRF ToC structure.
- Register for CESG/REP (if not yet) and ensure your internal submission workflows and IT infrastructure support electronic submission requirements.
- Use Health Canada’s folder templates and sample dossiers to prepare submissions.
- For existing products under development or already marketed, assess post-market documentation to ensure PMS and vigilance data follow structured format for future submissions.
- Maintain a clear record of proprietary vs public data and plan accordingly to avoid disclosure of sensitive information when licences are published.
CONCLUSION
The adoption of IMDRF ToC by Health Canada represents a significant move toward global regulatory alignment. For manufacturers, especially those operating internationally this harmonization can simplify submission processes, reduce duplication, and lead to more efficient regulatory interactions. However, compliance requires proactive planning: restructuring documentation, aligning internal processes, and ensuring readiness for electronic submission via CESG/REP. Companies that act promptly to adopt the new format will benefit from smoother reviews, better submission quality, and reduced risk of delays or rejections. For those of us offering regulatory consulting and support, this change underscores the need to update our internal SOPs, client checklists, and dossier preparation workflows. Adopting the IMDRF N86 FINAL:2026 guidance ensures precise, consistent adverse event reporting, enhancing global safety and regulatory compliance.