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| 02546cam 2200361zi 4500 |
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| 001 | 9.886859 |
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| 003 | CaOODSP |
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| 005 | 20221107171534 |
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| 006 | m o d f |
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| 007 | cr cn||||||||| |
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| 008 | 200505t20132013onc o f000 0 eng d |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH13-9/21-2013E-PDF |
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| 245 | 00|aGuidance document : |bmedical device licence renewal and fees for the right to sell licensed medical devices / |cHealth Products and Food Branch. |
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| 246 | 17|aHealth Canada guidance document : |bmedical device licence renewal and fees for the right to sell licensed medical devices |
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| 264 | 1|aOttawa, Ontario : |bHealth Canada = Santé Canada, |c2013. |
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| 264 | 4|c©2013 |
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| 300 | |a1 online resource (iii, 13 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 : renouvellement de l'homologation d'un matériel médical et frais à payer pour le droit de vendre un instrument médical homologué. |
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| 500 | |a"November 18, 2013." |
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| 500 | |aIssued also in HTML format. |
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| 520 | |a"This guidance document provides medical device manufacturers and their regulatory correspondents with the steps involved in renewing a medical device licence. The renewal process has two purposes: the first is to confirm whether the medical device will continue to be sold in Canada and the medical device licence will remain active; the second is to collect information that must be assessed prior to invoicing for the right to sell fee. This guidance document also provides guidance on the Fees in Respect of Drugs and Medical Devices Regulations (Fee Regulations) with a focus on how the Fees for the Right to Sell Licensed Class II, III or IV Medical Devices, contained in Part 3, Division 3 of these regulations, will be administered"--Introduction, page 1. |
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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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| 710 | 1 |aCanada. |bHealth Products and Food Branch. |
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| 775 | 08|tLigne directrice : |w(CaOODSP)9.886861 |
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| 856 | 40|qPDF|s320 KB|uhttps://publications.gc.ca/collections/collection_2020/sc-hc/H13-9-21-2013-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/guidance-document-medical-device-licence-renewal-fees-right-sell-licensed.html |
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