Would an Australian therapeutic claim bring the proposed product within TGA oversight?
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Would an Australian therapeutic claim bring the proposed product within TGA oversight?
The Therapeutic Goods Act 1989 defines therapeutic goods partly by how goods are represented, and the filter's label states that it is not a medical device and is not intended to diagnose, treat, cure or prevent disease.
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. Subsection 3(1) of the Therapeutic Goods Act 1989 defines therapeutic goods as goods “that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be: (i) for therapeutic use”, among other limbs and listed exclusions, and defines therapeutic use as “use in or in connection with: (a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons”, 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; Therapeutic Goods Act 1989 (Cth), subsection 3(1), Compilation No. 89, compilation date 5 September 2025, Federal Register of Legislation, read 20 September 2026, https://www.legislation.gov.au/C2004A03952/latest/text.
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