Health Canada Adopts the IMDRF Table of Contents (ToC) Format for Medical Device Submissions

Health Canada has officially adopted the International Medical Device Regulators Forum (IMDRF) Table of Contents (ToC) format for medical device submissions. This move supports global regulatory convergence and aims to reduce both time and cost for manufacturers and regulators.

The updated guidance aligns Health Canada’s submission structure with IMDRF headings for both IVDs and non-IVDs, and offers detailed instructions on expected content, technical specifications, submission media, and electronic filing requirements.

Key Implications for Manufacturers

1. Globally harmonised structure for submissions
Class II, III and IV applications — including private label and fax-back (minor change) — must now follow the IMDRF ToC format, allowing documentation to be reused across different regulatory jurisdictions.

2. Streamlined reviews and reduced burden
The structured ToC format supports faster screening, fewer requests for clarification, and more efficient dossier evaluation.

3. Applies to pre- and post-market submissions
Covers both new licence applications and post-market responses (including Sections 36 and 39 requests) across all device classes (I–IV).

4. Encouraged use of REP & CESG for digital filing
Health Canada encourages use of the Regulatory Enrolment Process (REP) and Common Electronic Submission Gateway (CESG). Submissions should use the Regulatory Transaction (RT) and Application Information (AI) templates.

5. Physical media accepted (for now)
Until REP becomes mandatory, physical submissions via CD/DVD, Blu-ray, USB, or external drives are still accepted — but must meet strict requirements (e.g. “Protected B” labelling, virus-free certification).

6. Tools and templates available
Health Canada provides folder templates, sample dossiers, and classification matrices to help manufacturers apply the correct ToC headings for their device class.