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.
Permanent link to this Catalogue record:
|Department/Agency||Canada. Health Canada, issuing body.|
|Title||Foreign risk notification for medical devices guidance document.|
|Other language editions||[French]|
|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)|
|Catalogue number|| |
|Subject terms||Medical instruments and apparatus -- Safety regulations -- Canada.|
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