Health Canada Reclassifies High-Level Disinfectants and Sterilants as Medical Devices

Among other products, this change will impact contact lens disinfectants that do not meet the antimicrobial agent definition in the Canada Food and Drug Regulations (“a drug that is capable of destroying pathogenic micro-organisms…”). As per the notice, high-level disinfectant and sterilant solutions for use on medical devices will fall under the definition of a Class II medical device. However, Health Canada intends to amend the Medical Device Regulations to reclassify these products as Class III medical devices.

There will be an 18 month transition period from when the notice was issued for manufacturers to obtain a medical device licence from Health Canada. Products that are currently marketed as drugs will need to receive a Quality Management System (QMS) certificate, update device labels to be in compliance with the Medical Device Regulations, submit the applicable medical device licence application and pay the fee, as well as demonstrate the safety and effectiveness compliance of the product. Until September 16, 2019, the affected products may remain on the market without a medical device licence.

Click to view the Notice:

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/notice-classification-licensing-high-level-disinfectants-sterilants.html