Health Canada to Reclassify Medical Device Sterilizers and Disinfectants
EMERGO SUMMARY OF KEY POINTS:
- Health Canada intends to reclassify medical device sterilizers and disinfectants from drugs to medical devices.
- Once reclassified, device sterilizers and disinfectants will have to comply with Canadian Medical Devices Regulations.
- Health Canada's reclassification of device sterilizers and disinfectants is an effort to align more closely with how other market regulators oversee such products.
Canadian medical device market regulator Health Canada plans to reclassify products used to disinfect and sterilize medical devices from pharmaceuticals to devices.
The regulator has explained that reclassifying disinfectants and sterilants—including contact lens disinfectants—as devices would “better align the Canadian requirements for these products with those of other jurisdictions in which these products are classified as medical devices.”
For the time being, however, these products will continue to be regulated under the Canadian Food and Drug Regulations as pharmaceuticals; following reclassification, they will fall under the country’s Medical Devices Regulations.
Health Canada is accepting comments until October 14, 2016 on the proposal, after which time the regulatory will issue a final notice and proceed with the reclassification plan.
Affected manufacturers of disinfectant and sterilization products can find more information on Health Canada’s medical device registration requirements by reading our whitepaper on obtaining a Medical Device License, watching our video overview or downloading our Canadian regulatory process chart.