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Proposed Reporting Requirement for Adverse Drug Reactions, Incidents Involving Medical Devices in Canada

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Health Canada published proposed regulations in Canada Gazette, Part I to amend the Food and Drug Regulations and Medical Devices Regulations to require hospitals to report serious adverse drug reactions and medical device incidents. This regulatory proposal supports authorities gained through the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law).

Under the proposed regulations, hospitals will be required to report to Health Canada all serious adverse drug reactions and medical device incidents, in writing, within 30 days of when the incident was first documented within the hospital. The proposed regulations aim to improve the quality and increase the quantity of serious adverse drug reaction and medical device incident reports provided to Health Canada.

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