Report a medical device incident: industry
Industry reporters include manufacturers, importers, distributors and retailers of all types and for all risk classes of medical devices.
On this page
- About reporting
- Report a medical device incident: mandatory
- File a medical device complaint: voluntary
- Report a foreign risk notification: mandatory
- About summary reports and issue-related analyses
About reporting
Mandatory reporting refers to when a professional or organization is legally required to report medical device incidents in certain circumstances.
In a voluntary reporting system, the reporting person does so without any legal or administrative requirement to do so.
Report a medical device incident: mandatory
The manufacturer and importer of a medical device must report any incidents concerning the device that occur in Canada if the device is sold in Canada. The incident must:
- involve a failure of the device, a deterioration in its effectiveness, inadequacy in its labelling or directions for use and
- have caused death, serious deterioration in health or have the potential to do so in the future
The requirement to report is stated in the Medical Devices Regulations.
Learn about what’s required in Incident reporting for medical devices.
Report a medical device incident
File a medical device complaint: voluntary
You may also file a voluntary industry complaint about a competitor's medical device or report an incident not covered by the mandatory reporting requirements.
These types of complaints go to the Medical Device Compliance Verification Unit within Health Canada’s Regulatory Operations and Enforcement Branch.
Learn more about our compliance and enforcement activities:
- Compliance and enforcement of medical devices
- Guidance on medical device compliance and enforcement (GUI-0073)
File a medical device complaint
Report a foreign risk notification: mandatory
Medical device licence holders must provide a foreign risk notification report within 72 hours of receiving or learning about a notifiable action. This reporting requirement applies to:
- licence holders of Class II to IV devices
- importers of Class II to IV devices and
- licence holders of an investigational testing authorization
The requirement to report is stated in the Medical Devices Regulations.
Learn more:
Report a foreign risk notification
About summary reports and issue-related analyses
Summary reports and issue-related analyses help identify changes to what’s known about the benefits and risks of medical devices used in Canada.
Licence holders of Class II, III and IV medical devices must comply with the summary report provisions under sections 61.4 to 61.6 of the regulations. They must notify us if they determine there has been a change in what’s known about the benefits or risks of their device.
Licence holders and manufacturers of Class I medical devices must comply with the issue-related analysis of safety and effectiveness provisions under sections 25(1) and 39 of the regulations. They must submit an issue-related analysis when a request is received from us and within the timelines specified.
These regulatory requirements cover the regulation of medical devices in Canada over their lifecycle. Strengthening monitoring after a device is authorized for sale helps to ensure that safety and effectiveness requirements continue to be met.
Learn more: