Coming soon! Mandatory reporting of serious adverse drug reactions and medical device incidents


On December 16, 2019 regulations supporting Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) come into effect. As of that date all hospitals in Canada are required to report to Health Canada information about any serious adverse drug reaction or medical device incident. The hospital has 30 calendar days from when the event was first documented in the hospital to submit the information to Health Canada. This requirement is in keeping with the requirements laid out in sections C.01.020.1 in the Food and Drug Regulations and section 62 of the Medical Device Regulations.

This mandatory reporting will supply Health Canada with additional post-market safety information about therapeutic products and therefore help Health Canada and others to take appropriate action when a serious risk to health is identified.

What is a serious adverse drug reaction or a medical device incident?

  • Serious adverse drug reaction: “a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death; a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death.” (Part C, Division 1, subsection C.01.001(1.1) of the Food and Drug Regulations)

  • Medical device incident: “an incident related to a failure of a medical device, a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use that has led to the death or a serious deterioration in the state of health of a patient, user or other person or could do so were it to recur.” (Section 62(4) of the Medical Devices Regulations)

Interested in learning more? Check out the following resources.

The modules are downloadable and can be modified for individual use or organizations. They were developed by the following collaborating parties: Health Canada, Canadian Patient Safety Institute, ISMP Canada, and Health Standards Organization (HSO).

CSHP, as a member of Health Canada’s Advisory Panel for the ADR/MDI Mandatory Reporting Initiative, contributed to the development of the modules.