Canada : Categorisation of products at device/drug interface to be clarified

摘要

Health Canada is developing a guidance document to better explain how it decides on the categorisation of therapeutic products at the medical device/drug interface, where the applicable regulatory framework is not immediately apparent.The government department admits that its application of the definitions of "drug" and "device", as stated in the Food and Drugs Act, has evolved over the time as a result of which "not all previous decisions will be indicative of how these products will be categorized in the future".Specifically, the department states that it interprets these definitions in a manner that considers not only how a product achieves its therapeutic function, "but also how its composition and characteristics are both represented and perceived in the marketplace".