Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Overview

Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Overview 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 Device Regulations. 2021-06-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyhospitalsmandatory reportingadverse drug reactionsmedical device incidentsFood and Drug RegulationsMedical Devices Regulations Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - OverviewHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-hospital-reporting/drugs-devices/guidance.html#a1-2 Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - OverviewHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/declaration-effets-indesirables/declaration-obligatoire-hopitaux/medicaments-instruments/orientation.html#a1-1

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 Device Regulations.

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