Foreign risk notification for medical devices guidance document: Responsibilities and notifiable actions
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- Who’s responsible for foreign risk notification
- Notifiable actions that require foreign risk notification
Who’s responsible for foreign risk notification
Both the medical device licence holder and holder of an establishment licence to import Class II to IV medical devices are responsible for providing Health Canada with information under the FRN requirements. (See section 61.2 of the Regulations.) The exception is if the manufacturer provides Health Canada with written authorization permitting the importer to report on its behalf. (See section 61.3(1) of the Regulations.)
Manufacturers are still responsible for ensuring that the information in the report is complete and accurate.
Notifiable actions that require foreign risk notification
Medical device licence holders and importers of Class II to IV devices must notify Health Canada when there’s a serious risk of injury to human health concerning a device authorized for sale in Canada and when:
- a notifiable action is taken by a foreign regulator of a certain jurisdiction or
- the licence holder and importer take notifiable actions in certain foreign jurisdictions
Notifiable actions that constitute a serious injury to human health include:
- public risk communication
- labelling change that has been communicated to or requested by a relevant foreign regulatory agency
- recall, including product withdrawal
- suspension or revocation of an authorization
Note: The regulatory requirements only apply when a foreign action has taken place, not when action is being contemplated.
Examples of notifiable actions where the device is authorized for sale in Canada:
- A regulatory agency requires a manufacturer to reassess a medical device due to finding that there’s a potential new or increased serious risk of injury to health from using the device.
- The labelling of a medical device is misleading. This is identified as the cause of a new or increased serious risk of injury to health. As a result, the regulatory agency in the jurisdiction suspends the device authorization until the labelling is changed.
- A foreign regulatory agency or a manufacturer issues a communication informing the public that patients with certain characteristics shouldn’t use a medical device as there may be a new or increased serious risk of injury to health.
- A medical device company or regulatory agency in a foreign jurisdiction conducts a lot-specific recall to mitigate a potential serious risk of injury to human health (for example, death or hospitalization) from a medical device.
- A manufacturer identifies a new or increased serious risk of injury to health from the use of its medical device. As a result, it has recalled the product from the market in one or more foreign jurisdictions.
Examples that don’t require foreign risk notification:
- A manufacturer of a medical device issues a public communication about a product enhancement that has been implemented for reasons unrelated to mitigation or elimination of a serious risk of injury to health.
- A manufacturer of a Class II medical device has received complaints from users of its device, describing that hospitalization has taken place as a result of complications related to using it. The manufacturer concludes that it isn’t necessary or hasn’t been requested by the foreign regulatory agency to undertake any of the “notifiable actions” listed above.
- A manufacturer of a Class I device has received complaints from users of its device, describing that hospitalization has taken place, in any foreign jurisdiction, as a result of complications related to using it. Incident reporting under section 59(1.1) applies.
- A periodic review required by legislation in a foreign jurisdiction is submitted to one of the specified regulatory agencies or jurisdictions.
- A serious risk of injury to health is identified and a risk communication is issued in one of the specified foreign jurisdictions, but the device isn’t authorized for sale in Canada.
- A device is associated with an injury in one of the specified foreign jurisdictions, but neither the manufacturer nor the regulatory agency has yet to take action to manage or mitigate future risk.
- A licence is suspended in one of the specified foreign jurisdictions for a reason that is not relevant to the safety of the device, such as not paying the required processing fee.
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