Compare

Compare archived captures

This view highlights text differences between two archived captures. It does not interpret meaning or provide guidance.

Descriptive changes only

This comparison highlights text changes between archived captures. It does not interpret the change or provide medical advice. For up-to-date recommendations, always consult the official source website.

Need to cite this comparison? See /cite.

Compare to the live pageView snapshot

Earlier capture

Guidance document: Classification of products at the drug-medical device interface - Canada.ca

Apr 19, 2025

legacy-hc-2025-04-21

ID 158370

Original URL ↗
View snapshot

Later capture

Guidance document: Classification of products at the drug-medical device interface - Canada.ca

Jan 2, 2026

hc-20260101

ID 428842

Original URL ↗
View snapshot
updated3 sections changed
3 sections changed0 added0 removed+3 / -4 linesChange ratio: 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