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
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance document : classification of products at the drug-medical device interface. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| 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 |
| Description | 1 online resource (12 pages) |
| ISBN | 9780660381282 |
| Catalogue number |
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| Departmental catalogue number | 200578 |
| Subject terms | Medical instruments and apparatus -- Canada. Drugs -- Canada. |
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