000
| 01604nam 2200361zi 4500 |
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001 | 9.882300 |
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003 | CaOODSP |
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005 | 20230612093842 |
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006 | m o d f |
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007 | cr ||||||||||| |
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008 | 191121t20192019onc ob f000 0 eng d |
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020 | |a9780660333076 |
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040 | |aCaOODSP|beng|erda|cCaOODSP |
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043 | |an-cn--- |
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086 | 1 |aH164-291/2-2019E-PDF |
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245 | 00|aGuidance document : |bsoftware as a medical device (SaMD) : definition and classification. |
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264 | 1|aOttawa : |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 | |aIssued also in French under title: Ligne directrice : logiciels à titre d’instruments médicaux : définition et classification. |
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500 | |a"Date adopted: 2019/10/03; effective date: 2019/12/18." |
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500 | |a"Publication date: December 18, 2019." |
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500 | |aIssued also in HTML format. |
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504 | |aIncludes bibliographical references. |
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650 | 0|aMedical instruments and apparatus industry|xGovernment policy|zCanada. |
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710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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775 | 08|tLigne directrice : |w(CaOODSP)9.882301 |
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856 | 40|qPDF|s275 KB|uhttps://publications.gc.ca/collections/collection_2020/sc-hc/H164-291-2-2019-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.html |
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