Meeting legal obligations for supplying COVID-19 test kits

We are no longer prioritising COVID-19 test applications.

See Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG.

Conditions imposed on all approved COVID-19 tests

All COVID-19 tests that are included in the ARTG, based on an expedited assessment process and/or limited validation data, have been subject to additional non-standard conditions. 

Post-market surveillance activities continue to be informed by these conditions.

Additional conditions

Additional conditions are being imposed on the supply of COVID-19 serology-based tests (i.e., serological rapid screening tests) and rapid antigen tests for use at the point-of-care and for self-testing to ensure the tests are used and interpreted appropriately. Point-of-care tests require the involvement of a suitably trained health practitioner. A rapid antigen self-test can be done by without the involvement of a health practitioner.

See Conditions on all COVID-19 tests approved for ARTG inclusion.

In vitro diagnostic (IVD) test sponsors can apply for inclusion in the ARTG. Once approved, the test can be supplied in Australia.

All COVID-19 test kits approved by the TGA for inclusion in the ARTG are listed on the COVID-19 test kit page. See COVID-19 rapid antigen self-tests included in the ARTG for more.

This device can only be supplied by an approved sponsor of a COVID-19 test or a person acting on their behalf. 

All sponsors of COVID-19 tests included in the ARTG have ongoing responsibilities under: 

• the Therapeutic Goods Act 1989 (the Act), 
• Therapeutic Goods (Medical Devices) Regulations 2002 and 
• Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021- external site (the Advertising Code), including conditions that apply automatically to all ARTG entries. 

We encourage all sponsors of COVID-19 tests to review this information.

See how to seek medical attention- external site if you are sick and think you have symptoms of COVID-19.

COVID-19 test kits and what to do if you get a positive result may vary by state.

COVID-19 Class 1-3 in-house IVDs

Class 1-3 in-house IVD medical devices used for COVID-19 diagnostic testing can be developed by a laboratory under the regulatory requirements for in-house IVDs. Laboratories can make in-house IVDs by adapting Research Use Only Products (RUO) tests or by developing their own assays to test for COVID-19 infections. Class 1-3 in-house IVDs do not require inclusion in the ARTG.

Regulatory requirements for labs that make and use Class 1-3 IVDs include:

• be NATA accredited to ISO 15189 (for a medical testing laboratory); and
• comply with the requirements of the NPAAC standard, Requirements for the development and use of in-house in vitro diagnostic medical devices; and
• submit a notification to us by 1 July of that financial year.

Use of alternative COVID-19 sample types

Use of alternative specimen types, such as self-collected saliva samples (i.e., sample types not validated by the manufacturer) for COVID-19 diagnostic testing requires validation by the laboratory as a Class 1-3 in-house IVD.

For information on in-house IVDs go to the regulatory requirements.

For more information about COVID-19 tests:

Email IVDs@tga.gov.au

Telephone 1800 141 144

For general COVID-19 enquiries contact the National Coronavirus Helpline on:

Telephone 1800 020 080 (available 24 hours a day, seven days a week)