Foreign risk notification for medical devices guidance document: Responsibilities and notifiable actions

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Who’s responsible for foreign risk notification

Both the medical device licence holder and holder of an establishment licence to import Class II to IV medical devices are responsible for providing Health Canada with information under the FRN requirements. (See section 61.2 of the Regulations.) The exception is if the manufacturer provides Health Canada with written authorization permitting the importer to report on its behalf. (See section 61.3(1) of the Regulations.)

Manufacturers are still responsible for ensuring that the information in the report is complete and accurate.

Notifiable actions that require foreign risk notification

Medical device licence holders and importers of Class II to IV devices must notify Health Canada when there’s a serious risk of injury to human health concerning a device authorized for sale in Canada and when:

Please refer to the List of Regulatory Agencies for the Purposes of Section 61.2 of the Medical Devices Regulations.

Notifiable actions that constitute a serious injury to human health include:

Note: The regulatory requirements only apply when a foreign action has taken place, not when action is being contemplated.

Examples of notifiable actions where the device is authorized for sale in Canada:

Examples that don’t require foreign risk notification:

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