Foreign risk notification for medical devices guidance document: Background

Effective Date: June 23, 2021
Updated: October 4, 2024

This guidance document is to help holders of Canadian authorizations for 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, 61.3 and 68.3 of the Medical Devices Regulations (the regulations).

The FRN requirements are intended to:

• improve the collection and assessment of new information concerning actions taken in response to 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.

Under the FRN sections of the regulations, actions by manufacturers or regulatory agencies to mitigate a serious risk in specified foreign jurisdictions must be reported to Health Canada. The reporting requirement applies to:

• a medical device licence holder 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 section 68.12 of the regulations for a Class II to IV device that is not a UPHN medical device, and
• a holder of an authorization under subsection 83(1) of the regulations (Investigational Testing Authorization).

A "private label manufacturer" (a person who sells a private label medical device under their own trademark) that holds a licence under section 36(1) or authorization under section 68.12 is responsible for complying with the requirement to submit FRN reports.

This requirement to notify Health Canada about foreign risks replaces the requirement for holders of Canadian authorizations for Class II to IV devices to report an incident that occurs outside of Canada, as required under the former section 59 of the regulations.

Note: The FRN provisions under sections 61.2, 61.3 and 68.3 don't apply to holders of authorizations for the sale/import of Class I devices. However, the incident reporting requirements under subsection 59(1.1) apply to Class I manufacturers and importers.

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of the Regulations and other applicable guidance documents.