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?
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