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:
- 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, licence holders and/or importers should also provide the following information:
- name and contact information of the medical device licence holder and/or importer
- brand name and manufacturer of the foreign product
- brand name of the relevant Canadian product
- Canadian 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 and/or already taken in Canada by the manufacturer 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 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.
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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