Report a medical device incident: industry

Canada's Food and Drugs Act and Regulations set out specific reporting requirements and timelines for mandatory reports. These require regulated parties to report serious medical device incidents.

Report a medical device incident

Industry representatives can also file a complaint about a competitor's medical device or report an incident not covered by mandatory reporting requirements.

File a medical device complaint

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.

Related links

• Medical devices
• Medical Device Foreign Risk Notification
• MedEffect Canada
• Advisories, warnings and recalls
• Medical device incidents database
• Medical devices establishment licence listing
• Mandatory reporting for industry - guidance document
• Medical Devices Active Licence Listing (MDALL)