Device Or Drug? Canada Updates Classification Guidance For Difficult To Distinguish Products

Health Canada’s revised guidance on classifying products at the device-drug interface reflects legislative changes the government has made. The agency also says that previous classification decisions may need to be reviewed in the light of new scientific and other evidence.

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Canada sheds new light on how to classify products at the device-drug interface

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 this front.

Products at the device-drug interface can present a challenge for manufacturers when it comes to determining whether device or drug...

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