This case is a clean, practical warning for businesses that sell regulated products in a rush. The product was not an ordinary promotional item. A rapid antigen test is a medical device, and the Therapeutic Goods Act regime requires the right kind of inclusion in the Australian Register of Therapeutic Goods before import, supply and representations about approval.
The mistake was not just that the products were imported and sold. The representations also mattered. Emails said or conveyed that the tests were TGA approved or supported by an ARTG record, when the record did not cover Key Promotional's tests in the required way. The Court accepted that the conduct happened in a pandemic context, that there was no evidence of actual harm, and that the company made a loss. Even so, the risk to public health and the need for general deterrence were central.
For small businesses, the lesson is simple: do not rely on supplier assurances, similar product listings or another company's registration when selling regulated health, therapeutic, diagnostic, cosmetic-adjacent or safety products. Verify the exact legal basis for import, supply and advertising, and keep the verification record before taking orders.