Health Canada issued a notice and is intended to inform industry of the regulatory classification of UV light-emitting decontamination products making COVID-19 claims. Health Canada also wishes to provide information on the applicable pathways for market authorization.
UV light-emitting products are typically sold as lamps, wands and small or large chambers. They make various claims related to decontamination and are sold and represented using terms such as disinfection, sterilization, sanitization, decontamination, and cleaning. In addition to disinfecting hard surfaces, UV light has been used for many years to decontaminate water and purify indoor air quality.
Health Canada regulates UV light-emitting decontamination products as either pest control products or medical devices based on their intended use and representation.
Manufacturers of these products should not make claims related to COVID-19 unless the claims can be supported by evidence. To date, these claims have not been substantiated in scientific literature or in applications received by Health Canada.
Health Canada has not yet authorized any UV light-emitting products with claims that they protect against or prevent SARS-CoV-2 infection and transmission. As of August 5th, 2021, Health Canada has only authorized 1 UV light-emitting decontamination product without COVID claims as a pest control product.
Manufacturers, importers and distributors making unsubstantiated claims related to the SARS-CoV-2 virus and COVID-19 will be subject to compliance and enforcement actions. These include being referred to the Competition Bureau, which is monitoring the marketplace and taking action to stop deceptive marketing practices related to COVID-19.
The Competition Act prohibits false or misleading claims about any product. It also prohibits performance claims that are not supported with adequate and proper testing. The Competition Bureau has issued warnings to a number of manufacturers and businesses, including those claiming their products filter out or inactivate SARS-CoV-2.
The Competition Bureau actively monitors the marketplace to stop deceptive claims.
More details and information on the requirements is found on Health Canada’s website here.
You may send your questions or comments about this notice to the Medical Devices Directorate at hc.meddevices-instrumentsmed.sc@canada.ca.