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Guidance document : classification of products at the drug-medical device interface.: H164-316/2021E-PDF

"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.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.897928&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleGuidance document : classification of products at the drug-medical device interface.
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • 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."
Publishing information
  • [Ottawa] : Health Canada = Santé Canada, 2021.
  • ©2021
Description1 online resource (12 pages)
ISBN9780660381282
Catalogue number
  • H164-316/2021E-PDF
Departmental catalogue number200578
Subject terms
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