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
| Department/Agency | Canada. Health Canada. |
|---|---|
| Title | Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals : guidance document. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| 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 |
| Description | 1 online resource (iv, 40 pages) |
| ISBN | 9780660312163 |
| Catalogue number |
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| Departmental catalogue number | 190097 |
| Subject terms | Health care facilities Side effects Legislation |