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Incident reporting for medical devices : guidance document.: H164-310/2021E-PDF

"The purpose of this guidance document is to assist manufacturers, importers and authorization holders in understanding and complying with the Medical Devices Regulations concerning incident reporting"--Introduction, page 1.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.895027&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleIncident reporting for medical devices : guidance document.
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • "January 2021."
  • Cover title.
  • "Effective Date: June 23, 2021; supersedes: October 3, 2011."
  • Issued also in HTML format.
  • Issued also in French under title: Rapports d’incidents liés aux matériels médicaux : lignes directrices.
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, 2021.
  • ©2021
Description1 online resource (iii, 15 pages)
ISBN9780660370422
Catalogue number
  • H164-310/2021E-PDF
Departmental catalogue number200337
Subject terms
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