Disinfectant Drugs; Class II Medical Devices (ICS: 11.040)

Notice on the Classification and Licensing of High-Level Disinfectants and Sterilants as Medical Devices (1 page, available in English and French)

As one initiative under the Canada-United States Regulatory Cooperation Council (RCC), Health Canada is reclassifying high-level disinfectants and sterilant solutions, including contact lens disinfectants, intended for use on medical devices. These products are being reclassified from drugs to medical devices to better align Canadian regulatory requirements with those of the United States. All medical device disinfectants and sterilants that do not meet the definition of an antimicrobial agent, as defined in section C.01A.001(1) of the Food and Drug Regulations (FDR) are no longer regulated under the FDR and are subject to the requirements of the Medical Devices Regulations. Health Canada is allowing an 18-month transition period from the date of this publication for manufacturers of market authorized disinfectants and sterilants to obtain quality management system (QMS) certificates. Further information on how to obtain a QMS certificate is available at www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/quality-systems-13485.html