Health Canada IMDRF table of contents for medical device applications guidance. : H164-405/2025E-PDF

"The International Medical Device Regulators Forum (IMDRF) is a voluntary group of regulators committed to the acceleration of medical device regulatory harmonization and convergence. The Table of Contents (ToC) format was developed by the IMDRF to provide a globally harmonized structure and has been adopted by Health Canada for medical device regulatory activities. … This guidance incorporates content from the In Vitro Diagnostic Medical Device Regulatory Submission Table of Contents (IVD ToC) and Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC) published by IMDRF and regional guidance specific to Canadian submissions. The guidance supports manufacturers and regulatory correspondents in preparing ToC-based medical device submissions to Health Canada. …"--Introduction and background, page 4.

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