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 determine whether adequate risk mitigation measures have also 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 does not replace the implementation of risk mitigation actions in Canada by authorization holders.

How to submit

Reporting can be submitted online using an electronic form. This form will be available on Canada.ca.

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