Description

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.

Resources

Name	Format	Description	Link
Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Overview	HTML		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 - Overview	HTML		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

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