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.

Data and Resources

Additional Info

Field Value
Last Updated January 16, 2026, 21:09 (UTC)
Created January 16, 2026, 21:09 (UTC)
contains_pii non
crisis_categories Sécurité publique
criticality_level Moyen
data_formats HTML
fair_openness Level 2 - Machine-readable
geographic_scope Canada
sensitivity_level Faible
source_inventaire Inventaire_W
source_url https://open.canada.ca/data/en/dataset/2123e32f-4423-4de8-9067-26209e6bae81
subject health_and_safety
update_frequency as_needed
year_most_recent 2021-06-01 17:11:39.728000
year_start 2021-06-01 17:11:39.728000