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Health Canada adapted assembly and technical guide for IMDRF table of contents submissions.: H164-404/2025E-PDF

"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.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.956798&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleHealth Canada adapted assembly and technical guide for IMDRF table of contents submissions.
Variant title
  • Health Canada adapted assembly and technical guide for International Medical Device Regulators Forum table of contents submissions
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • 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.
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, November 2025.
  • ©2025
Description1 online resource (22 pages) : colour illustration
ISBN9780660795201
Catalogue number
  • H164-404/2025E-PDF
Departmental catalogue number250296
Subject terms
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