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
Department/Agency | Canada. Health Canada. |
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Title | Guidance document : software as a medical device (SaMD) : classification examples. |
Variant title | Software as a medical device (SaMD) : classification examples |
Publication type | Monograph |
Language | [English] |
Other language editions | [French] |
Later edition | Guidance document : |
Format | Electronic |
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 |
Description | 1 online resource (16 pages) |
ISBN | 9780660333052 |
Catalogue number |
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Departmental catalogue number | 190470 |
Subject terms | Medical instruments and apparatus -- Government policy -- Canada. |
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