Foreign risk notification for medical devices guidance document.: H164-308/2021E-PDF

"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"--Background, page 1.

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Publication information
Department/Agency Canada. Health Canada, issuing body.
Title Foreign risk notification for medical devices guidance document.
Publication type Monograph
Language [English]
Other language editions [French]
Format Electronic
Electronic document
Note(s) Issued also in French under title: Lignes directrices sur les communications étrangères relatives aux risques liés aux instruments médicaux.
Issued also in HTML format.
Publishing information Ottawa, ON : Health Canada = Santé Canada, January 2021.
Description 1 online resource (9 pages)
ISBN 9780660370361
Catalogue number
  • H164-308/2021E-PDF
Subject terms Medical instruments and apparatus -- Safety regulations -- Canada.
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