Report a medical device incident: hospitals

There are new mandatory reporting requirements for hospitals. Hospitals must report, in writing, within 30 days of documenting the medical device incident. We encourage hospitals to report sooner.

Health care professionals who work in a hospital should check with their hospital administration to learn about any new requirements.

Report a medical device incident

Please download the form to your desktop before filling out.

To report through the secure File Transfer Protocol (sFTP), contact the Canada Vigilance Program.

What products are included

Medical devices range from adhesive bandages, toothbrushes and contact lenses to complex devices, such as x-ray units, insulin pumps and pacemakers. They also include in vitro diagnostic devices, such as cancer screening tests, blood glucose monitors and pregnancy test kits.

Devices are classified according to their level of risk, with Class I being the lowest risk and Class IV being the highest risk.

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