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Guidance document: Classification of products at the drug-medical device interface - Canada.ca
19 avr. 2025
legacy-hc-2025-04-21
ID 158370
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Guidance document: Classification of products at the drug-medical device interface - Canada.ca
2 janv. 2026
hc-20260101
ID 428842
updated3 sections changed
3 sections modifiées0 ajoutées0 retirées+3 / -4 lignesVariation: 3%
--- +++ @@ -1,5 +1,5 @@ Guidance document: Classification of products at the drug-medical device interface-(PDF Version - 64 K)+(PDF Version - 428 KB) Notice July 22, 2021 Our file number: 21-112631-972@@ -17,7 +17,7 @@ Guidance Document: Classification of Products at the Cosmetic-Drug Interface ," which address Health Canada's classification of products at other interfaces. This document reflects an approach that considers the F&DA definitions of "device" and "drug" in a contextual manner. For questions on the classification of products at the drug-medical device interface, please contact the Office of Science in the Bureau of Policy, Science and International Programs (BPSIP) of the Therapeutic Products Directorate at-Drug-Device.Classification.Drogue-Instrument@hc-sc.gc.ca+drug.device.classification-drogue.instrument@hc-sc.gc.ca . Guidance document Published by authority of the Minister of Health@@ -124,5 +124,4 @@ There are differences between the definitions in the Canadian legislation and those used by other regulatory authorities. In addition, the interpretations by other regulators of their own definitions may further affect whether they classify a product as a device or a drug. Health Canada may consult the classification decisions of foreign regulatory authorities as a tool to assist in interpreting and applying the definitions of the F&DA. While Health Canada seeks to align device/drug classifications globally when feasible, a product would still need to meet the definitions in the F&DA and its regulations. Page details-Date modified:-2021-07-22+2025-07-28