Health Canada proposes regulations to require hospitals to report serious adverse drug reactions, medical device incidents

Health Canada's proposed regulations to amend the Food and Drug Regulations and Medical Devices Regulations would require hospitals to report serious adverse drug reactions and medical device incidents. The proposal supports measures included in the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law). The changes would require hospitals to report all serious adverse drug reactions and medical device incidents to Health Canada within 30 days of when the incident was first documented within the hospital. Canadians and stakeholders can provide feedback on the proposal until August 29.
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