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Factors Influencing the Classification of Products at the Device-Drug Interface - PharmaFacts
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Factors Influencing the Classification of Products at the Device-Drug Interface

Guidances - Health Canada Guidances

Health Canada is pleased to announce the release of the Guidance Document: Factors Influencing the Classification of Products at the Device-Drug Interface.

The classification of a health product determines which regulations will apply. Although the majority of products can be readily classified according to the definitions in the Food and Drugs Act (the Act) and its associated regulations, classification decisions become difficult when the applicable regulations are not immediately apparent. Classification guidance documents describe the factors that influence these decisions by Health Canada, and are intended to increase transparency and predictability.

This document addresses the classification of two therapeutic product groups (devices and drugs). It complements other guidance documents, including "Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats" and "Guidance Document: Classification of Products at the Cosmetic-Drug Interface", that address Health Canada's classification of products at other interfaces. Health Canada will continue to clarify other interfaces, as needed, as part of its commitment to operational excellence.

This guidance reflects an evolved approach that considers the Act's definitions of "device" and "drug" in a contextual manner. The factors described in this document are derived from... (read more)