Health Canada intends to improve the collection and assessment of new information relevant to the safety of a medical device in certain foreign jurisdictions to help determine an appropriate response in Canada to any risks reported.
Per the Foreign Risk Notification sections of Medical Device Regulations, any notifiable actions initiated by manufacturers or regulatory agencies to mitigate a serious risk of injury to human health in specified foreign jurisdictions (List of Regulatory Agencies) must be reported to Health Canada. This reporting requirement is applicable to:
- A medical device licence holder (including private label manufacturers) for a Class II to IV device.
- An establishment licence holder that imports Class II to IV devices (“importer”)
- A holder of an authorization under subsection 83(1) of the Regulations (Investigational Testing Authorization)
Please note that manufacturers are responsible for ensuring that all the submitted information in FRN reports are complete and accurate, even if the importer has been permitted to report on the manufacturer’s behalf.
Notifiable action relating to safety to be reported constitute any action (e.g., public risk communication, labelling change requested by regulators, recall, reassessment/ suspension /revocation of an authorization) taken by a foreign regulator or authorization holder in certain foreign jurisdictions.
Authorization holders are required to submit the completed Medical Device Foreign Risk Notification Form within 72 hours of when they become aware of a notifiable action.
If you need further information or require help in completing a Foreign Risk Notification Form, please contact us.
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