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0861 |aH164-405/2025E-PDF
24500|aHealth Canada IMDRF table of contents for medical device applications guidance.
24613|aHealth Canada International Medical Device Regulators Forum table of contents for medical device applications guidance
264 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cNovember 2025.
264 4|c©2025
300 |a1 online resource (13 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aIssued 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.
500 |a"Pub.: 250294"--Page 2.
504 |aIncludes bibliographical references.
520 |a"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.
650 0|aMedical instruments and apparatus|xGovernment policy|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLignes directrices de Santé Canada pour les demandes d'homologation d'instruments médicaux fondées sur la table des matières de l'IMDRF.|w(CaOODSP)9.956805
85640|qPDF|s550 KB|uhttps://publications.gc.ca/collections/collection_2026/sc-hc/H164-405-2025-eng.pdf
8564 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/international-medical-device-regulators-forum.html
986 |a250294