Disinfecting/Sanitizing Devices and Regulatory Requirements
By: Joe McCarthy, Lab Service Manager/Senior Regulatory Affairs Specialist, email
In response to the COVID-19 pandemic many new and innovative products such as Ultraviolet (UV) light decontamination, Ozone generators, Electrolyzed Water, and Hypochlorous Acid devices are being offered for sanitization and disinfecting purposes.
A device used to sanitize or disinfect any medical device including but not limited to masks, gowns, eyeglasses, thermometers, is itself considered a Class II medical device and requires pre-market approval and registration with the Medical Devices Directorate (MDD).
A device used to sanitize or disinfect non-medical equipment in the home or workplace such as cellphones, keys, door handles, hard surfaces, fabrics are considered Pest Control Product Devices and requires pre-market approval and registration with the Pest Management Regulatory Agency (PMRA).
All Disinfecting/Sanitizing Devices have detailed requirements for effectiveness and safety. At this time no Disinfecting/Sanitizing Devices have been approved by Health Canada for uses against COVID -19
Do you know if your device is a Medical Device or a Pest Control Product?
Do you know what the effectiveness and safety requirements are for your device?
Do you know how and where to apply for registration?
Joe McCarthy, Senior Regulatory Affairs Specialist
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