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

On this page

• Information to submit
• Timelines
• How to submit

Information to submit

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

• the foreign regulatory agency that took the notifiable action and/or the foreign jurisdiction in which the action was taken
• the action taken by the foreign regulatory agency or by the company in the jurisdiction

Where applicable, authorization holders should also provide the following information:

• name and contact information of the medical device authorization holder submitting the report
• brand name and manufacturer of the foreign product
• brand name of the relevant Canadian product
• Canadian authorization number (e.g., medical device licence number)
• product identifier, part number or catalogue number
• lot number
• a description of the reasons for the action, including information about the serious risk being mitigated and what is known about the root cause
• a description of any actions being planned in Canada in response to the identified serious risk
  • provide reference numbers if available
• give a rationale explaining why action isn't warranted if no action is planned in Canada

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:

• recall notices
• risk communications
• notifications of label change

However, when describing the notifiable action taken, give enough detail, including how the action taken was communicated. It's important that Health Canada has sufficient information to 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

An FRN report must be provided within 72 hours of when the authorization holder 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.

An authorization holder 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 class II to IV 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:

• refer to a previously submitted relevant FRN report; and
• only include information specific to the new information (i.e., additional actions and/or jurisdictions).

How to submit

The Medical Device Foreign Risk Notification Form includes all necessary fields and instructions to support the submission of information required by sections 61.2 and 61.3 of the Regulations (Serious Risk of Injury to Human Health).

FRN reports should be submitted to Health Canada by email (as an attachment) at: mdd.postmarket-postcommercialisation.dim@hc-sc.gc.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.