| 000 | 00000cam 2200000zi 4500 |
| 001 | 9.957363 |
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| 003 | CaOODSP |
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| 005 | 20260216122641 |
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| 006 | m o d f |
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| 007 | cr cn |||||||| |
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| 008 | 251117e202511##onc o f000 0 eng d |
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| 020 | |a9780660797458 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-409/2025E-PDF |
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| 245 | 00|aClass III IVD applications content and classification guidance. |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cNovember 2025. |
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| 264 | 4|c©2025 |
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| 300 | |a1 online resource (108 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 French under title: Lignes directrices sur le contenu et la classification des demandes d'homologation d'instruments diagnostique in vitro de classe III. |
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| 520 | |a"Any information submitted to Health Canada should be accompanied by a cover letter. The cover letter should include the purpose of the application and a brief description of the package being submitted. It may also include proprietary information pertaining to the submission"--Health Canada guidance, page 5. |
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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 le contenu et la classification des demandes d'homologation d'instruments diagnostique in vitro de classe III.|w(CaOODSP)9.957364 |
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| 856 | 40|qPDF|s1.09 MB|uhttps://publications.gc.ca/collections/collection_2026/sc-hc/H164-409-2025-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/international-medical-device-regulators-forum/class-iii-ivd-applications-content-classification.html |
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| 986 | |a250349 |
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