High Level Disinfectants Reclassified…Be in the know
By: Sarah Calder, Regulatory Affairs Specialist, email
Last month Health Canada released a notice of the reclassification of high-level disinfectants and sterilants used on medical devices in Canada. As of March 16, 2018, these products are regulated under the Medical Devices Bureau as Class II Medical Devices, and will no longer regulated as drugs under the Food and Drugs Act.
The purpose of this reclassification was to bring into line products sold in Canada, with the United States and other countries, where high level disinfectants and sterilants are currently regulated as medical devices.
Under the Medical Device Regulations these products, used on semi-critical and critical medical devices, will be required to demonstrate quality, safety and effectiveness of label claim. This involves an evaluation of manufacturing quality, a complete application for licensing, and label compliance. New-to-market products will be required to meet these regulations, whereas those with existing market authorization will have an 18-month transition period to come into compliance.
Are your products affected? Do you need assistance with your Class II Medical Device license application? Are your unsure if your product is a high-level disinfectant or still categorized as a antimicrobial agent under the Food and Drug Regulations? Contact Dell Tech today for product registrations.