Health Canada Reclassifies Certain Disinfectants as Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- Health Canada will begin regulating some disinfectants and sterilizing solutions including contact lens solution as medical devices.
- Affected products are now considered Class II devices, but Health Canada intends to eventually reclassify them as Class III devices.
- Affected manufacturers will have 18 months to obtain Medical Device Licenses (MDL).
Canadian healthcare market regulator Health Canada has reclassified some disinfectant and sterilizing solutions including contact lens cleaners as medical devices as part of an effort to align more closely with US Food and Drug Administration regulations.
According to Health Canada’s notice, disinfectants and sterilizing solutions intended for use on medical devices and that do not meet the Canadian Food and Drug Regulations definition of an antimicrobial agent are considered Class II devices as of March 16, 2018. These substances had previously been regulated as drugs in Canada.
Up-classification to Class III planned
Although Health Canada has just reclassified high-level disinfectants and sterilizing solutions as Class II devices, the agency plans to up-classify these products to Class III devices by amending the Canadian Medical Devices Regulations (CMDR).
Transition period for CMDR compliance
Health Canada’s notice lays out Medical Device Licensing (MDL) requirements for both currently commercialized and new affected products.
- Manufacturers of disinfectant and sterilization products previously registered as drugs will have to submit MDL applications including proof of quality management system certification and device labels to Health Canada. Plus, affected manufacturers will need to supply Health Canada with their products’ Drug Identification Numbers (DIN) to confirm safety and effectiveness compliance. These manufacturers have an 18-month transition period to obtain MDLs while legally marketing their products in Canada.
- New Canadian market registrants for disinfectants and sterilization solutions used on medical devices will be required to submit MDL applications effective March 16, 2018. These MDL applicants must also provide information demonstrating that their products meet CMDR sections 10-20.