Language selection

Government of Canada / Gouvernement du Canada

Search

Risk classification guide for medical device establishment inspections.: H14-327/2019E-PDF

"This document is intended to help ensure consistency among Health Canada inspectors during medical device establishment inspections when: classifying observations of deviations, deficiencies or failures according to risk; assigning an overall compliance rating to an inspection. It also informs anyone with a medical device establishment licence (MDEL) of the situations Health Canada considers unacceptable that may result in a non-compliant (NC) rating and/or compliance and enforcement actions"--page 5.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.873314&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleRisk classification guide for medical device establishment inspections.
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Guide de classification des risques pour les inspections d'établissements d'instruments médicaux.
  • "GUI-0079."
  • "January 31, 2020."
  • "Archived"–Health Canada, 7 November 2025.
  • Issued also in HTML format.
  • Includes bibliographical references (pages 27-28).
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, 2020.
  • ©2020
Description1 online resource (28 pages)
ISBN9780660309828
Catalogue number
  • H14-327/2019E-PDF
Departmental catalogue number190053
Subject terms
Request alternate formats
To request an alternate format of a publication, complete the Government of Canada Publications email form. Use the form’s “question or comment” field to specify the requested publication.

Page details

Report a problem or mistake on this page
Date modified: