00000cam 2200000zi 4500 9.956798 CaOODSP 20260121110415 m o d f cr cn||||||||| 251028e202511##onca ob f000 0 eng d 9780660795201 CaOODSP eng rda CaOODSP n-cn--- H164-404/2025E-PDF Health Canada adapted assembly and technical guide for IMDRF table of contents submissions. Health Canada adapted assembly and technical guide for International Medical Device Regulators Forum table of contents submissions Ottawa, ON : Health Canada = Santé Canada, November 2025. ©2025 1 online resource (22 pages) : colour illustration text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Guide technique et sur l'assemblage adapté aux présentations fondées sur la table des matières de l'IMDRF de Santé Canada. "Pub.: 250296"--Page 2. Includes bibliographical references. "This guide provides Health Canada-specific instructions for assembling a regulatory submission package using the Table of Contents (ToC) structure defined by the International Medical Device Regulators Forum (IMDRF). The content was derived from the IMDRF document titled Assembly and technical guide for IMDRF Table of Contents submissions. This document provides specific guidelines for building a ToC-based submission, including harmonized guidelines for the acceptable folder structure and file format(s). …"--Introduction, page 4. Medical instruments and apparatus Government policy Canada. Canada. Health Canada, issuing body. Guide technique et sur l'assemblage adapté aux présentations fondées sur la table des matières de l'IMDRF de Santé Canada. (CaOODSP)9.956801 PDF 708 KB https://publications.gc.ca/collections/collection_2026/sc-hc/H164-404-2025-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/adapted-assembly-technical-guide-submissions.html 250296