Foreign risk notification for medical devices guidance document: What, when and how to submit

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Information to submit

To comply with the Regulations, licence holders and/or importers of Class II to IV medical devices must provide the following information:

Where applicable, licence holders and/or importers should also provide the following information:

It isn't necessary to provide the original documents that are issued to health care professionals or to the public as part of the foreign action, such as:

However, when describing the notifiable action taken, give enough detail, including how the action taken was communicated. It's important that Health Canada understand what was shared with health care professionals or the public in the foreign jurisdiction. Health Canada may ask for copies of these documents later.

FRN reports must be in either English or French. Additional documents (for example, recall notices, risk communications) relating to the issue aren't required but may be requested by Health Canada at a later date. These too must be in English or French.

Timelines

A foreign risk notification (FRN) report must be provided within 72 hours of when the manufacturer or importer receives or becomes aware of a notifiable action. This will allow Health Canada to consider the situation and understand whether risk mitigation measures should been taken in Canada.

A manufacturer or importer is responsible for identifying and implementing actions to be taken in Canada in order to comply with the Regulations. Submission of a FRN report does not replace the implementation of risk mitigation actions in Canada by authorization holders.

As a reminder, submission of a FRN report is required when the following three conditions have been met:

  1. There's a serious risk of injury to human health concerning a device authorized for sale in Canada;
  2. A notifiable action has been taken for the purpose of mitigating or eliminating the serious risk; and
  3. The action took place within the jurisdiction(s) of one or more regulatory agencies that is included in the List of Regulatory Agencies for the Purposes of Section 61.2 of the Medical Devices Regulations.

In some cases, one or more notifiable actions in response to a serious risk of injury to human health may be taken in more than one foreign jurisdiction set out in the List of Regulatory Agencies for the Purposes of Section 61.2 of the Medical Devices Regulations. Similarly, different or additional actions may be taken in different jurisdictions or as more is learned about the risk(s).

A single FRN report should be submitted to Health Canada related to serious risk of injury to human health, even if more than one notifiable action is taken and/or if notifiable actions are taken in more than one foreign jurisdiction. If different actions were taken in different jurisdictions, there would be an opportunity on the FRN form to provide a brief description.

Of note, however, a FRN report must be submitted to Health Canada within 72 hours after the holder receives or becomes aware of information that a notifiable action has taken place in response to a serious risk. Therefore, as more is learned about the risk, it is possible that additional actions will be taken or that actions will be taken in additional jurisdictions following the submission of an initial FRN report.

In this situation, additional FRN reports must be submitted to Health Canada within 72 hours. Any additional reports should:

How to submit

A fillable Foreign Risk Notification (FRN) form has been developed. To receive a copy of the form by email, contact Health Canada’s Medical Devices Directorate at:
hc.mdd.postmarket-postcommercialisation.dim.sc@canada.ca.

FRN reports should be submitted to Health Canada by email (as an attachment) at:
hc.mdd.postmarket-postcommercialisation.dim.sc@canada.ca.
In the subject line of the email, it should be specified that a “FRN report” is being submitted.

Health Canada will follow up with the submitter only if a FRN report is incomplete or if additional information is necessary to understand the situation.

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