Last September, Health Canada announced by the notice “Intent to Reclassify Disinfectants and Sterilants for Use on Medical Devices” the reclassification of disinfection and sterilization products, including contact solutions from drugs to Medical Devices.
Goal of this update is to be consistent with the legislations of the Countries where these products are already regulated as Medical Devices.
Moreover, the risk classes will be applied considering what internationally already established.
Currently and for this devices category, pharmaceutical regulations (Food And Drug Regulations) is to be followed, but, thanks to the new classification, the Medical Device Regulation (MDR) will be applied in the future.
The term for collecting comments on the Notice was October 14, 2016. At the moment further news are expected.
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