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| 02207cam 2200397zi 4500 |
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| 001 | 9.878679 |
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| 003 | CaOODSP |
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| 005 | 20221107165316 |
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| 006 | m o d f |
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| 007 | cr cn||||||||| |
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| 008 | 190829t20202020onca ob f000 0 eng d |
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| 020 | |a9780660324043 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH14-334/2019E-PDF |
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| 245 | 00|aGuidance on medical device establishment licensing (MDEL). |
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| 246 | 17|aGuidance on medical device establishment licensing (MDEL) (GUI-0016) version 8 |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2020. |
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| 264 | 4|c©2020 |
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| 300 | |a1 online resource (42 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: Document d'orientation concernant l'octroi d'une licence d'établissement d'instruments médicaux (LEIM). |
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| 500 | |a"GUI-0016." |
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| 500 | |a"April 1, 2020." |
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| 500 | |a"Pub.: 190319." |
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| 500 | |aIssued also in HTML format. |
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| 504 | |aIncludes bibliographical references (pages 39-41). |
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| 520 | |a"This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements in relation to Medical Device Establishment Licences (MDEL), including when and how to apply for an MDEL, and how to maintain an MDEL once issued. This guidance document does not cover importing medical devices for personal use or for use on animals"--Purpose, page 6. |
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| 650 | 0|aMedical instruments and apparatus industry|xLicenses|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tDocument d'orientation concernant l'octroi d'une licence d'établissement d'instruments médicaux (LEIM).|w(CaOODSP)9.878680 |
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| 856 | 40|qPDF|s734 KB|uhttps://publications.gc.ca/collections/collection_2020/sc-hc/H14-334-2019-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/document.html |
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