High-level disinfectants and sterilant solutions have been largely regulated in Canada as drug products as per Health Canada’s Food and Drug Regulations (FDR). However as of March of this year, disinfectants and sterilants that do not meet the definition of an antimicrobial agent under the FDR are now be regulated as medical devices. This includes products such as contact lens disinfectants.
This reclassification of disinfectants and sterilants was accomplished under the Canada-United States Regulatory Cooperation Council (RCC) Work Plan for Medical Devices. The RCC was established in 2011 and works to align the regulatory requirements between Canada and the United State as well as increase transparency and coordination between the two countries. At the time of publishing, the disinfectants and sterilants that will be reclassified will be considered Class II medical devices.
An antimicrobial agent is defined by Health Canada as a drug that can destroy pathogenic microorganisms and are labelled for use in disinfecting environmental surfaces or medical devices. On the other hand, a high-level disinfectant is labelled as a substance that can destroy or inactivate microbial pathogens but not bacterial endospores. Sterilants are like disinfectants and are capable of destroying or inactivating bacterial and fungal spores as well as viruses.
Health Canada is allowing an 18-month transition period for manufacturers of affected products to obtain quality management system (QMS) certificates, a medical device licence and a medical device establishment licence (MDEL). Those who have products that will not be affected by this reclassification are expected to maintain their necessary Drug Establishment Licence (DEL).
For new products that will be sold as medical devices, manufacturers will be required to provide Health Canada with information that demonstrates that their disinfectant and sterilant meets the safety and effectiveness requirements for medical devices.
For more information, please contact Focal Point Research Inc. We are leading Canadian regulatory and Health Canada consultants for Medical Devices and other consumer products.