Canada: Updated guidance on classification for “Device” or “Drug“ products

Health Canada has issued updated guidance on how it classifies healthcare products that do not readily fall within the definition of a medical device or a drug to reflect legislative changes and provide more clarity on the classification.

The agency also says that previous classification decisions may need to be reviewed in the light of new scientific and other evidence.

The classification of device/drug combination products, which combine at least one device component and one drug component, is outside the scope of this guidance.

This guidance is also not intended to address the classification of cells, tissues and organs.

For the guidance please click here: Health Canada Notice: Guidance Document: Classification of Products at the (Medical) Device-Drug Interface .

 

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