Health Canada Reclassifies Sterilant Solutions, Disinfectants as Devices
Posted 16 March 2018 | By
Health Canada announced Friday that effective today, high-level disinfectant and sterilant solutions (including contact lens disinfectants) intended for use on medical devices are now classified as Class II medical devices.
Health Canada said it is allowing an 18-month transition period for manufacturers of market authorized disinfectants and sterilants to obtain quality management system (QMS) certificates. The Canadian regulator also said it intends to pursue an amendment to the Medical Device Regulations (MDR) that would reclassify these products as Class III medical devices.
The reclassification of the products from drugs to devices is part of efforts to align US and Canadian regulatory requirements under the Canada-United States Regulatory Cooperation Council (RCC).
“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),” Health Canada said. “Disinfectants that meet the definition of an antimicrobial agent continue to be regulated as drugs and subject to the requirements of the FDR.”