Canada: Health Canada To Develop Guidance Clarifying Drug/Device Classification
Health Canada is announcing a notice pertaining to the categorization of Therapeutic Products. The notice indicates a product's mode of action will not necessarily determine whether a product is a medical device or a drug, and previous decisions will not be a litmus test for future product classification.
In order to enhance transparency, Health Canada intends to develop guidance that will clarify what factor will determine whether a product will be classified as a drug or device.
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Health Canada - Categorization of Therapeutic Products at the Device / Drug Interface