Foreign risk notification for medical devices guidance document: Definitions
- Notifiable action:
- An action taken in one of the specified jurisdictions relating to the safety of a medical device for the purpose of mitigating or eliminating a serious risk of injury to human health. Notifiable actions include risk communications, recalls, label changes, reassessments of authorization, and suspensions or revocations of authorization to prevent serious risk of injury to human health. An action relating to the medical device may include issues regarding the quality, effectiveness or performance characteristics of the medical device, if safety was impacted.
- Regulatory agency:
- A government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of medical devices within its jurisdiction and that may take enforcement action to ensure that medical devices marketed within its jurisdiction comply with the applicable legal requirements. (section 1, Medical Devices Regulations)
- An action taken by an authority to revoke, cancel or indeterminately suspend an authorization designed to mitigate or eliminate a serious risk of injury to human health.
- Serious risk of injury to human health:
A hazard associated with the medical device that is relevant to the safety of the medical device and that, without risk mitigation, would likely:
- be life-threatening
- result in persistent or significant disability or incapacity
- require inpatient hospitalization or prolonged hospitalization
- result in a serious health consequence such as loss of function or debilitating chronic pain
- result in death
For a discussion of “serious risk,” please refer to annex A of the Amendments to the Food and Drugs Act: Guide to New Authorities.
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