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.
Device-drug interface product classification guidance updated by Canada
Sign up for AdvaMed SmartBrief
Medical technology news
Get the intelligence you need: news and information that is changing your industry today, hand-curated by our professional editors from thousands of sources and delivered straight to your inbox.