Health Canada Reclassifies Sterilant Solutions, Disinfectants as Devices

Health Canada announced that sterilant solutions and disinfectants to be used with medical devices are now classified as medical devices.

The reclassification of high-level disinfectants and sterilant solutions falls under the Canada-United States Regulatory Cooperation Council (RCC) Work Plan for Medical Devices.

Medical device disinfectants and sterilants that don’t meet the definition of an antimicrobial agent are no longer regulated under Canada’s Food and Drug Regulations and are now subject to requirements of the Medical Device Regulations (MDR), the regulator explained.