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| 01737nam 2200325zi 4500 |
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| 001 | 9.897928 |
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| 003 | CaOODSP |
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| 005 | 20221107174718 |
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| 006 | m o d f |
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| 007 | cr ||||||||||| |
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| 008 | 210325s2021 xxc o f00| 0 eng d |
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| 020 | |a9780660381282 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-316/2021E-PDF |
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| 245 | 00|aGuidance document : |bclassification of products at the drug-medical device interface. |
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| 264 | 1|a[Ottawa] : |bHealth Canada = Santé Canada, |c2021. |
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| 264 | 4|c©2021 |
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| 300 | |a1 online resource (12 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 : classification des produits situés à la frontière entre les drogues et les instruments médicaux. |
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| 500 | |a"Effective Date: 2021/07/22." |
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| 520 | |a"This guidance is intended to assist stakeholders in the classification of products at the drug medical device interface when the appropriate regulatory framework is not immediately evident. Products at the drug-medical device interface are those that do not readily fall within the definition of “device” or “drug” as set out in section 2 of the Food and Drugs Act (F&DA). Therefore, these products present a challenge when determining which set of regulations apply"--page 8. |
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| 650 | 0|aMedical instruments and apparatus|zCanada. |
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| 650 | 0|aDrugs|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLignes directrice : |w(CaOODSP)9.897929 |
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| 856 | 40|qPDF|s245 KB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H164-316-2021-eng.pdf |
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