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Guidance document : software as a medical device (SaMD) : classification examples.: H164-291/1-2019E-PDF

"Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective"--Foreword, page 3.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.882298&sl=0

Publication information
Department/Agency
  • Canada. Health Canada.
TitleGuidance document : software as a medical device (SaMD) : classification examples.
Variant title
  • Software as a medical device (SaMD) : classification examples
Publication typeMonograph
Language[English]
Other language editions[French]
Later editionGuidance document :
FormatDigital text
Electronic document
Note(s)
  • Title from cover.
  • Issued also in HTML format.
  • "Publication date: December 18, 2019."
  • "Date adopted: 2019/10/03."
  • "Effective date: 2019/12/18."
  • Issued also in French under title: Ligne directrices : logiciels à titre d’instruments médicaux (LIM) : exemples de classification.
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, 2019.
  • ©2019
Description1 online resource (16 pages)
ISBN9780660333052
Catalogue number
  • H164-291/1-2019E-PDF
Departmental catalogue number190470
Subject terms
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