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| 02197nam 2200385zi 4500 |
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| 001 | 9.895017 |
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| 003 | CaOODSP |
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| 005 | 20240917104214 |
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| 006 | m o d f |
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| 007 | cr cn||||||||| |
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| 008 | 210104t20212021onc o f000 0 eng d |
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| 020 | |a9780660370385 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-309/2021E-PDF |
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| 245 | 00|aGuidance on summary reports and issue-related analyses for medical devices. |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2021. |
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| 264 | 4|c©2021 |
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| 300 | |a1 online resource (i, 11 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 | |aCover title. |
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| 500 | |aIssued also in HTML format. |
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| 500 | |a"Publication date: January 2021." |
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| 500 | |aIssued also in French under title: Lignes directrices sur les rapports de synthèse et les analyses liées à un sujet de préoccupation pour les instruments médicaux. |
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| 520 | |a"This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices Regulations. Two new requirements in the Regulations were added to ensure the continued monitoring of benefits and risks after a product is authorized for sale in Canada"--Purpose of the guidance document, page 1. |
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| 650 | 0|aMedical instruments and apparatus|xSafety regulations|zCanada. |
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| 650 | 0|aMedical instruments and apparatus|xGovernment policy|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLignes directrices sur les rapports de synthèse et les analyses liées à un sujet de préoccupation pour les instruments médicaux.|w(CaOODSP)9.895018 |
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| 794 | |tGuidance on summary reports and issue-related analyses for medical devices.|w(CaOODSP)9.943289 |
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| 856 | 40|qPDF|s688 KB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H164-309-2021-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/medical-device-reports-analyses-guidance.html |
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