Health Canada Issues Guidance on Foreign Risk Notification

Health Canada has released guidance to help device manufacturers and importers comply with the agency’s foreign risk notification (FRN) requirements for reporting a serious risk of injury.

Device license holders and importers of Class II to IV devices must notify Health Canada when there is a serious risk of injury to human health concerning a device authorized for sale in Canada when a notifiable action is taken by a foreign regulator or when the license holder and importer take notifiable actions in certain foreign jurisdictions.

Notifiable actions include risk communications, recalls, label changes, reassessments, suspensions or revocations of authorization to prevent serious risk of injury to human health, the agency said.