Would a medical claim change the Canadian class or licence route for the complete device?
Last reviewed: .
Would a medical claim change the Canadian class or licence route for the complete device?
The filter's label states that it is not a medical device and is not intended to diagnose, treat, cure or prevent disease, and the company publishes no position under Canadian law.
The label for the NanoFlashing™ Air Filter states: “This filter treats the air that passes through it. It is not a medical device and is not intended to diagnose, treat, cure or prevent disease. It works alongside ventilation and cleaning, not in place of them.” The Terms of Use state: “Do not use Site Content to diagnose, treat, or make a patient-care or infection-control decision.” They also state: “A laboratory reduction in a virus, bacterium, fungus, particle, or other endpoint does not establish a clinical benefit, fewer infections, disease prevention or treatment, or improved health.” The Terms further state that the Medical devices chapter describes a Research Application, and that it does not describe a finished product currently available from C-POLAR for that use. Section 2 of the Food and Drugs Act defines a device as “an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in (a) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals”, among other uses. The company sets out its own position under United States law and under Regulation (EU) No 528/2012, and under no other.
Source: C-POLAR — Terms of Use (https://cpolar.tech/terms/); NanoFlashing™ Air Filter label; Food and Drugs Act (R.S.C., 1985, c. F-27), section 2, Justice Laws Website, current to 21 July 2026, read 20 September 2026, https://laws-lois.justice.gc.ca/eng/acts/F-27/FullText.html.
Reviewed on .