00000cam 2200000zi 4500 9.956803 CaOODSP 20260121113843 m o d f cr cn||||||||| 251028e202511##onc ob f000 0 eng d 9780660795225 CaOODSP eng rda CaOODSP n-cn--- H164-405/2025E-PDF Health Canada IMDRF table of contents for medical device applications guidance. Health Canada International Medical Device Regulators Forum table of contents for medical device applications guidance Ottawa, ON : Health Canada = Santé Canada, November 2025. ©2025 1 online resource (13 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Lignes directrices de Santé Canada pour les demandes d'homologation d'instruments médicaux fondées sur la table des matières de l'IMDRF. "Pub.: 250294"--Page 2. Includes bibliographical references. "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. Medical instruments and apparatus Government policy Canada. Canada. Health Canada, issuing body. Lignes directrices de Santé Canada pour les demandes d'homologation d'instruments médicaux fondées sur la table des matières de l'IMDRF. (CaOODSP)9.956805 PDF 550 KB https://publications.gc.ca/collections/collection_2026/sc-hc/H164-405-2025-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/international-medical-device-regulators-forum.html 250294