Notice for Industry: Mandatory Reporting Requirement during the COVID-19 Pandemic

Notice for Industry: Mandatory Reporting Requirement during the COVID-19 Pandemic In light of the COVID-19 outbreak, Health Canada is clarifying expectations for manufacturers, importers and market authorization holders (MAHs) regarding requirement to report adverse reactions (ARs) and medical device problems (MDPs) during a pandemic. 2020-04-07 Health Canada open-ouvert@tbs-sct.gc.ca Government and PoliticsHealth and SafetyNotice for IndustryCOVID-19 outbreakpandemic Notice for Industry: Mandatory Reporting Requirement during the COVID-19 PandemicHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-industry-mandatory-reporting-requirement-covid-19-pandemic.html Notice for Industry: Mandatory Reporting Requirement during the COVID-19 PandemicHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/annonces/avis-industrie-exigence-declaration-obligatoire-pandemie-covid-19.html

In light of the COVID-19 outbreak, Health Canada is clarifying expectations for manufacturers, importers and market authorization holders (MAHs) regarding requirement to report adverse reactions (ARs) and medical device problems (MDPs) during a pandemic.

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