| 000 | 00000cam 2200000zi 4500 |
| 001 | 9.956798 |
|---|
| 003 | CaOODSP |
|---|
| 005 | 20260121110415 |
|---|
| 006 | m o d f |
|---|
| 007 | cr cn||||||||| |
|---|
| 008 | 251028e202511##onca ob f000 0 eng d |
|---|
| 020 | |a9780660795201 |
|---|
| 040 | |aCaOODSP|beng|erda|cCaOODSP |
|---|
| 043 | |an-cn--- |
|---|
| 086 | 1 |aH164-404/2025E-PDF |
|---|
| 245 | 00|aHealth Canada adapted assembly and technical guide for IMDRF table of contents submissions. |
|---|
| 246 | 13|aHealth Canada adapted assembly and technical guide for International Medical Device Regulators Forum table of contents submissions |
|---|
| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cNovember 2025. |
|---|
| 264 | 4|c©2025 |
|---|
| 300 | |a1 online resource (22 pages) : |bcolour illustration |
|---|
| 336 | |atext|btxt|2rdacontent |
|---|
| 337 | |acomputer|bc|2rdamedia |
|---|
| 338 | |aonline resource|bcr|2rdacarrier |
|---|
| 500 | |aIssued 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. |
|---|
| 500 | |a"Pub.: 250296"--Page 2. |
|---|
| 504 | |aIncludes bibliographical references. |
|---|
| 520 | |a"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. |
|---|
| 650 | 0|aMedical instruments and apparatus|xGovernment policy|zCanada. |
|---|
| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
|---|
| 775 | 08|tGuide technique et sur l'assemblage adapté aux présentations fondées sur la table des matières de l'IMDRF de Santé Canada.|w(CaOODSP)9.956801 |
|---|
| 856 | 40|qPDF|s708 KB|uhttps://publications.gc.ca/collections/collection_2026/sc-hc/H164-404-2025-eng.pdf |
|---|
| 856 | 4 |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/adapted-assembly-technical-guide-submissions.html |
|---|
| 986 | |a250296 |
|---|