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

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Who's responsible for foreign risk notification

The reporting requirement applies to a medical device licence holder for a Class II to IV device, an establishment licence holder that import a Class II to IV device (“importer”), and a holder of an authorization under subsection 83(1) of the Regulations (Investigational Testing Authorization) for a Class II to IV device. As a licence holder, a “private label manufacturer” (a person who sells a private label medical device under their own trademark) is responsible for complying with the requirement to submit FRN reports. (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 subsection 61.3(1) of the Regulations.) If a manufacturer wants to permit the importer of the device to submit FRN reports to Health Canada on the manufacturer’s behalf, Health Canada must be notified in writing, by email at:

The following form is recommended to be used to notify Health Canada that an importer has been permitted to submit FRN reports on a manufacturer’s behalf: “Authorization for medical devices mandatory problem, foreign risk notification, and recall reporting according to sections 61.1, 61.3, and 65.1 of the Medical Devices Regulations and/or designation to Act as the Canadian regulatory contact”. To receive a copy of the form, contact Health Canada’s Regulatory Operations and Enforcement Branch at

Note: Private label manufactures are considered to be “manufacturers” and, therefore, are responsible for complying with Section 61.3 of the Regulations. If a private label manufacturer wants to permit an importer to submit FRN reports on their behalf, Health Canada must be notified as described above.

Manufacturers are responsible for ensuring that information in FRN reports is complete and accurate. This is true even if the importer has been permitted to report on the manufacturer’s behalf.

Holders of a medical device establishment licence for distribution, but not for importation (i.e., “distributors”) are not responsible for submitting FRN reports.

Notifiable actions that require foreign risk notification

Medical device licence holders, importers, and Investigational Testing Authorization holders 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:

Regulatory requirements and definitions may differ in various foreign jurisdictions and from those in Canada. The definition of the action in the foreign jurisdiction(s) should be used when determining whether an FRN report must be submitted to Health Canada. For example, if an action in a foreign jurisdiction is considered a “recall” in that jurisdiction, but this same action is not considered a recall according to the Canadian Medical Devices Regulations, it is a “notifiable action” for the purposes of FRN reporting.

Note: Submission of a FRN report is NOT required if:

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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