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Guidance on using standards to support compliance with the Medical Devices Regulations.H164-389/2025E-PDF

"This document provides guidance to manufacturers on using standards to support compliance with the following requirements under the Medical Devices Regulations (regulations): safety and effectiveness requirements, labelling requirements"--Introduction, page 3.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.949593&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleGuidance on using standards to support compliance with the Medical Devices Regulations.
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Ligne directrice sur l'utilisation des normes en vue d'assurer le respect du Règlement sur les instruments médicaux.
  • "Unclassified / Non classifié."
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, January 2025.
  • ©2025
Description1 online resource (9 pages)
ISBN9780660766997
Catalogue number
  • H164-389/2025E-PDF
Departmental catalogue number240983
Subject terms
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