Canada: New Reclassification Rules for certain Device Disinfectants And Sterilants
Health Canada has reclassified from drugs to medical devices high-level disinfectant and sterilant solutions that are intended for use on medtech products.
Disinfectants and sterilants (including contact lens disinfectants) that do not meet the definition of an antimicrobial agent under the Canadian Food and Drug Regulations are now subject to the requirements of the Medical Devices Regulations and considered to be Class II medical devices.
Manufacturers of already authorized disinfectants and sterilants have been given an 18-month transition period to meet the new rule and obtain the necessary quality management system certificate. They will also need to complete and submit an application and pay the fee for a class II medical device licence and ensure their device label complies with the MDR.
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