Buying rapid antigen kits


If your business buys rapid antigen test kits to use in your business operations or to sell, there are laws you need to be aware of.

Importing rapid antigen tests

If you would like to import rapid antigen tests to use in your business operations or to sell in Australia, you'll need to ensure you are purchasing an approved product on the Australia Register of Therapeutic Goods (ARTG).

Any rapid antigen tests that are imported for commercial supply must be the version manufactured and approved for the Australian market and not a parallel import. The tests must be on the ARTG, under the name of the supplier, prior to importation.

Failing to adhere to the Australian rules can result in penalties.

Learn more about the rules for importing rapid antigens tests.

Reporting a problem with testing kits your business buys

Problems or issues with a test can be reported back to the place where you purchased the test or to the supplier of the test through the customer support contact information provided in the instructions provided with the test.

You can also report the problem directly to the Therapeutic Goods Administration (TGA) through their online form.

Your supplier is required to report serious adverse events related to the use or performance of the device, and all complaints associated with false positive and false negative results to the TGA.

Selling rapid antigen test kits


Advertising the rapid antigen test kits you are selling

When you advertise the rapid antigen test kits your business sells, you must comply with the Therapeutic Goods Advertising Code.

Legally, your business cannot say or imply the advertised goods are approved or endorsed by the TGA or any other government authority.

Representations used in advertising that refer to COVID-19 must be approved or authorised by the TGA. The TGA has authorised legally-binding requirements for what advertisements for COVID-19 rapid antigen self-tests can and cannot say.

Find guidance on lawfully advertising COVID-19 rapid antigen tests for supply to consumers.

Price-gouging

Businesses are free to set the prices of their products or services. Neither the ACCC or your local state or territory agency have roles in setting prices.

But the Australian Consumer Law does protect consumers from unconscionable conduct by businesses. This means you shouldn't exploit customers, especially if your product or service is critical to health or safety, such as rapid antigen testing kits.

Whilst there isn't a precise legal definition for unconscionable conduct, you should always ensure that your conduct isn't so harsh that it goes against good conscience.

Find the latest information on increasing product prices due to COVID-19.

Including GST

If you are selling rapid antigen COVID-19 test kits, you need to include GST in the price of these kits. This is because rapid antigen COVID-19 test kits are not a ‘medical aid or appliance’ that is listed in either Schedule 3 to the GST Act or the GST Regulations, so they’re not GST-free.

Learn more about the supply of medical aids and appliances used for treating COVID-19.

Read next

Find more COVID-19 information and support for business.

Learn more about buying and selling your products online.

Follow our steps for using COVID-19 rapid antigen tests in your business operations.