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| 01852nam 2200337zi 4500 |
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| 001 | 9.895015 |
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| 003 | CaOODSP |
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| 005 | 20221107173915 |
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| 006 | m o d f |
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| 007 | cr ||||||||||| |
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| 008 | 210104e202101##onc o f000 0 eng d |
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| 020 | |a9780660370361 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-308/2021E-PDF |
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| 245 | 00|aForeign risk notification for medical devices guidance document. |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cJanuary 2021. |
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| 264 | 4|c©2021 |
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| 300 | |a1 online resource (9 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: Lignes directrices sur les communications étrangères relatives aux risques liés aux instruments médicaux. |
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| 500 | |aIssued also in HTML format. |
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| 520 | |a"This guidance document is to help manufacturers and importers of medical devices understand and comply with the regulatory requirements on foreign risk notification (FRN). The requirements deal with serious risk of injury to human health and are set out in sections 61.2 and 61.3 of the Medical Devices Regulations"--Background, page 1. |
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| 650 | 0|aMedical instruments and apparatus|xSafety regulations|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLignes directrices sur les communications étrangères relatives aux risques liés aux instruments médicaux.|w(CaOODSP)9.895016 |
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| 856 | 40|qPDF|s627 KB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H164-308-2021-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/foreign-risk-notification-medical-devices-guidance.html |
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