Reclassification of High-Level Disinfectants and Sterilant Solutions as Class II Medical Devices

by | Mar 26, 2019 | Canadian Regulatory, Medical Devices | 0 comments

Health Canada issued a notice on March 18th, 2018 regarding changes to classification of high-level disinfectant and sterilant solutions intended for use on medical devices. Instead of being regulated by the Food and Drug Regulations (FDR), disinfectants and sterilants used on medical devices are going to be regulated as Class II Medical Devices under Medical Device Regulations (MDR) if they do not meet the definition of an antimicrobial agent under Food and Drug Regulations (FDR).

Under these regulations, an antimicrobial agent is defined as a drug that is capable of destroying pathogenic micro-organisms and that is labelled as being for use in the disinfection of environmental surfaces or medical devices, as defined by the Medical Devices Regulations, that (a) are not invasive devices as defined in those Regulations; and (b) that are intended to come into contact with intact skin only

Why?

The reclassification is intended to improve regulatory alignment between Canada and the United States. Although these products are currently considered to be Class II medical devices, an amendment to the MDR will be pursued by Health Canada to further reclassify them as Class III medical devices in the future.

Currently Marketed Products

Health Canada is allowing authorized products to remain on the market during an 18-month transition period for manufactures to align their products with these new regulations. With approximately 6 months left until the deadline, Health Canada is aware that some manufacturers are having a hard time meeting Quality Management System (QMS) certification requirements to obtain a medical device licence for reclassified disinfectants and sterilants.

If you require assistance with applying for a Class II medical device licence, please contact Focal Point Research Inc.

We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.