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

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• Who's responsible for foreign risk notification
• Notifiable actions that require foreign risk notification

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: MDCU_UCIM@hc-sc.gc.ca.

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 MDCU_UCIM@hc-sc.gc.ca.

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:

• a notifiable action is taken by a foreign regulator of a certain jurisdiction or
• the authorization holder takes notifiable actions in certain foreign jurisdictions

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:

• public risk communication
• labelling change that has been communicated to or requested by a relevant foreign regulatory agency
• recall (e.g., product withdrawal)
• reassessment of an authorization
• suspension or revocation of an authorization

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:

• The action taken is not in response to a serious risk of injury to human health
• The action was taken in a jurisdiction that is not included in the List of Regulatory Agencies for the Purposes of Section 61.2 of the Medical Devices Regulations
• A foreign notifiable action is being contemplated, but has not yet taken place
• Within 72 hours, another method has been or will be used to notify Health Canada of action(s) taken in Canada to mitigate or eliminate the serious risk. For example, this could include submission of a recall notification as required under sections 63-65 of the Regulations. If, however, action is being planned in Canada, but will not have taken place within the 72 hour FRN reporting requirement, a FRN report must be submitted.

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

• A regulatory agency undertakes a reassessment of the authorization for a medical device due to finding that there’s a potential new or increased serious risk of injury to health from using the device.
• The labelling of a medical device is misleading. This is identified as the cause of a new or increased serious risk of injury to health. As a result, the regulatory agency in the jurisdiction suspends the device authorization until the labelling is changed.
• A foreign regulatory agency or a manufacturer issues a communication informing the public that patients with certain characteristics shouldn’t use a medical device as there may be a new or increased serious risk of injury to health.
• A medical device company or regulatory agency in a foreign jurisdiction conducts a lot-specific recall to mitigate a potential serious risk of injury to human health (for example, death or hospitalization) from a medical device.
• A manufacturer identifies a new or increased serious risk of injury to health from the use of its medical device. As a result, it has recalled the product from the market in one or more foreign jurisdictions.

Examples that don’t require foreign risk notification:

• A manufacturer of a medical device issues a public communication about a product enhancement that has been implemented for reasons unrelated to mitigation or elimination of a serious risk of injury to health.
• A manufacturer of a Class II medical device has received complaints from users of its device, describing that hospitalization has taken place as a result of complications related to using it. The manufacturer concludes that it isn’t necessary or hasn’t been requested by the foreign regulatory agency to undertake any of the “notifiable actions” listed above.
• A manufacturer of a Class I device has received complaints from users of its device, describing that hospitalization has taken place, in any foreign jurisdiction, as a result of complications related to using it. Incident reporting under subsection 59(1.1) applies instead.
• A periodic review required by legislation in a foreign jurisdiction is submitted to one of the specified regulatory agencies or jurisdictions.
• A serious risk of injury to health is identified and a risk communication is issued in one of the specified foreign jurisdictions, but the device isn’t authorized for sale in Canada.
• A device is associated with an injury in one of the specified foreign jurisdictions, but neither the manufacturer nor the regulatory agency has yet to take action to manage or mitigate future risk.
• A licence is suspended in one of the specified foreign jurisdictions for a reason that is not relevant to the safety of the device, such as not paying the required processing fee.