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.
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.
- Education modules to meet requirements for mandatory hospital reporting
- Case study on adverse reactions to drugs and problems with medical devices
- Medical devices
- MedEffect Canada
- Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Overview
- Advisories, warnings and recalls
- Medical device incidents database
- Medical devices establishment licence listing
- Canadian Medical Devices Sentinel Network (CMDSNet)
- Medical Devices Active Licence Listing (MDALL)
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