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Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals : guidance document.H164-280/2019E-PDF

"The purpose of this guidance document is to provide hospitals with information that may be useful in achieving compliance with the federal regulatory requirement for hospitals to report serious ADRs and MDIs to Health Canada as outlined in section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical DeviceRegulations"--Objective, page 1.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.874301&sl=0

Publication information
Department/Agency
  • Canada. Health Canada.
TitleMandatory reporting of serious adverse drug reactions and medical device incidents by hospitals : guidance document.
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Déclaration obligatoire des réactions indésirables graves à un médicament et des incidents liés aux instruments médicaux par les hôpitaux : document d’orientation.
  • Issued also in HTML format.
Publishing information
  • [Ottawa] : Health Canada = Santé Canada,June 2019.
  • ©2019
Description1 online resource (iv, 40 pages)
ISBN9780660312163
Catalogue number
  • H164-280/2019E-PDF
Departmental catalogue number190097
Subject terms
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