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.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.874301&sl=1
Ministère/Organisme | Canada. Health Canada. |
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Titre | Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals : guidance document. |
Type de publication | Monographie |
Langue | [Anglais] |
Autres langues publiées | [Français] |
Format | Électronique |
Document électronique | |
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. |
Information sur la publication | [Ottawa] : Health Canada = Santé Canada,June 2019. ©2019 |
Description | 1 online resource (iv, 40 pages) |
ISBN | 9780660312163 |
Numéro de catalogue |
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Numéro de catalogue du ministère | 190097 |
Descripteurs | Health care facilities Side effects Legislation |