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| 02084nam 2200409zi 4500 |
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| 001 | 9.882298 |
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| 003 | CaOODSP |
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| 005 | 20230612093709 |
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| 006 | m o d f |
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| 007 | cr ||||||||||| |
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| 008 | 191121t20192019onc o f000 0 eng d |
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| 020 | |a9780660333052 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-291/1-2019E-PDF |
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| 245 | 00|aGuidance document : |bsoftware as a medical device (SaMD) : classification examples. |
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| 246 | 10|aSoftware as a medical device (SaMD) : |bclassification examples |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2019. |
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| 264 | 4|c©2019 |
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| 300 | |a1 online resource (16 pages) |
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| 336 | |atext|btxt|2rdacontent |
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| 337 | |acomputer|bc|2rdamedia |
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| 338 | |aonline resource|bcr|2rdacarrier |
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| 500 | |aTitle from cover. |
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| 500 | |aIssued also in HTML format. |
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| 500 | |a"Publication date: December 18, 2019." |
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| 500 | |a"Date adopted: 2019/10/03." |
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| 500 | |a"Effective date: 2019/12/18." |
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| 500 | |aIssued also in French under title: Ligne directrices : logiciels à titre d’instruments médicaux (LIM) : exemples de classification. |
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| 520 | |a"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. |
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| 650 | 0|aMedical instruments and apparatus|xGovernment policy|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada. |
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| 775 | 08|tLigne directrices : |w(CaOODSP)9.882299 |
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| 794 | |tGuidance document : |w(CaOODSP)9.917706 |
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| 856 | 40|qPDF|s282 KB|uhttps://publications.gc.ca/collections/collection_2020/sc-hc/H164-291-1-2019-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance/examples.html |
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