This guidance document is to help manufacturers and importers of medical devices understand and comply with the regulatory requirements on foreign risk notification (FRN). The requirements deal with serious risk of injury to human health and are set out in sections 61.2 and 61.3 of the Medical Devices Regulations.
The FRN requirements are intended to:
- improve the collection and assessment of new information concerning any serious risk of injury to human health relevant to the safety of a medical device in certain foreign jurisdictions
- help determine an appropriate response in Canada to these risks
Important risks may be more likely to be detected in jurisdictions outside Canada where medical devices have been sold for a longer time or at a higher volume…