Classification and Licensing of High-Level Disinfectants and Sterilants as Medical Devices

Health Canada has published an industry notice advising effective March 16, 2018, high-level disinfectant and sterilant solutions (including contact lens disinfectants) intended for use on medical devices are classified by Health Canada as medical devices. Medical device disinfectants and sterilants that do not meet the definition of an antimicrobial agent in the Food and Drug Regulations (FDR) are no longer regulated under the FDR and are now subject to the requirements of the Medical Devices Regulations (MDR.) Disinfectants that meet the definition of an antimicrobial agent continue to be regulated as drugs and subject to the requirements of the FDR.

The reclassification of high-level disinfectant and sterilant solutions from drugs to medical devices is an initiative under the Canada-United States Regulatory Cooperation Council (RCC) Work Plan for Medical Devices. RCC initiatives are intended to better align the regulatory requirements of Canada and the United States.

At this time, these products are considered to be Class II medical devices, in accordance with Schedule 1, Part 1, Rule 13(b) of the Medical Devices Regulations. However, to better align the device risk classification with the nature and intended use of these products, Health Canada intends to pursue an amendment to the MDR that would reclassify these products as Class III medical devices.

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.

Medical Devices Licence Application fee forms can be found on Health Canada’s website here.