00000nam 2200000zi 4500 9.897928 CaOODSP 20221107174718 m o d f cr ||||||||||| 210325s2021 xxc o f00| 0 eng d 9780660381282 CaOODSP eng rda CaOODSP n-cn--- H164-316/2021E-PDF Guidance document : classification of products at the drug-medical device interface. [Ottawa] : Health Canada = Santé Canada, 2021. ©2021 1 online resource (12 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Ligne directrice : classification des produits situés à la frontière entre les drogues et les instruments médicaux. "Effective Date: 2021/07/22." "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. Medical instruments and apparatus Canada. Drugs Canada. Canada. Health Canada, issuing body. Lignes directrice : (CaOODSP)9.897929 PDF 245 KB https://publications.gc.ca/collections/collection_2021/sc-hc/H164-316-2021-eng.pdf 200578