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Device-drug interface product classification guidance updated by Canada
2/12/2018

The 2013 guidance on classifying products at the device-drug interface was updated by Health Canada to reflect modifications to the definition of a medical device under the Food and Drugs Act and better clarify its procedure in classifying such products. The government said new scientific and other evidence may result in the reclassification of some products, but sponsors will be given time to get the required market authorization under the appropriate set of regulations.

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