Legal supply of COVID-19 test kits
This is current advice relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections
The Therapeutic Goods Administration (TGA) continues to ensure that Australia has tests available to support efforts in managing the COVID-19 pandemic.
All COVID-19 test kits must be approved for inclusion in the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied in Australia. One exception to this is for Class 4 in-house IVDs being used to perform donor screening under the emergency exemption.
This is current advice relating to the supply of COVID-19 tests. As the COVID-19 situation changes, this advice may be amended. Please contact us at COVIDtests@tga.gov.au or 1800 141 144 if you need further information.
Priority TGA assessment of applications for COVID-19 tests
The TGA must prioritise applications based on the public health need.
For further information, see Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG.
Note: Applications relating to combination or multiplex (COVID/FLU) tests are being prioritised to ensure the needs of health care professionals and the Australian public are met.
Note: We are committed to supporting sponsors in their understanding of the Australian requirements for the supply of COVID-19 tests. Please direct all enquiries to COVIDtests@tga.gov.au or call 1800 141 144.
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. These conditions continue to inform post-market surveillance activities and allow active monitoring of these products.
Additional conditions specific to COVID-19 serology point-of-care tests, rapid antigen point-of-care tests and self-tests
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. Rapid antigen self-tests can be used by individuals without the involvement of a health practitioner.
For further information, see Conditions on all COVID-19 tests approved for ARTG inclusion.
COVID-19 test kits approved for inclusion in the ARTG
Sponsors (i.e. suppliers/importers) of a COVID-19 test may submit an application for inclusion of their in vitro diagnostic (IVD) test in the ARTG. Once the application is 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. Additional information on COVID-19 rapid antigen self-tests included in the ARTG is also available.
Only the approved sponsor of a COVID-19 test, or a person acting on their behalf in a distribution arrangement with the sponsor, can supply the device. All sponsors of COVID-19 tests included in the ARTG have ongoing responsibilities under the Act, the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Advertising Code), including conditions that apply automatically to all ARTG entries. We encourage all sponsors of COVID-19 tests to review this information.
The Department of Health website has information on how to seek medical attention if you are sick and think you have symptoms of COVID-19.
Note: The use of different COVID-19 test kits and the action required following a positive result may vary between the state and territory jurisdictions. Further information is available on the relevant government website.
Emergency exemption for COVID-19 donor screening
The emergency exemption, the Therapeutic Goods (Medical Devices—Donor Screening) (COVID-19 Emergency) Exemption 2023 has been remade to enable the continued use of unapproved COVID-19 tests by accredited pathology laboratories (as Class 4 in-house IVDs) for the purpose of donor screening. The emergency exemption will have effect until 30 June 2024.
The recommendation to perform this testing is set out in the Clinical Guidelines for Organ Transplantation from Deceased Donors published by the Australian Government Organ and Tissue Authority and the Transplantation Society of Australia and New Zealand (TSANZ).There are currently no commercially available Class 4 IVD medical devices included in the ARTG intended for screening donors of blood, tissues, organs etc for COVID-19. Laboratories are currently using their own tests, or modifying tests that are already approved for diagnostic use, to screen donors for COVID-19. Such tests are considered to be Class 4 in-house IVD medical devices, which would usually require inclusion in the ARTG (unless exempt). Under the exemption accredited pathology laboratories are still subject to certain regulatory requirements, such as keeping records, and post market reporting of adverse events.
To address long term supply, laboratories performing this testing will need to have access to commercial Class 4 IVDs for COVID-19 donor screening when the exemption expires or laboratories will require inclusion of their Class 4 in-house IVDs in the ARTG. An extension to the exemption may not be possible if COVID-19 is no longer declared a pandemic by the World Health Organisation.
The reference to accredited pathology laboratories- external site in this context is a reference to pathology laboratories accredited by the National Association of Testing Authorities (NATA) and/or Royal College of Pathologists of Australasia (RCPA) for Human Pathology Testing (under the Health Insurance Act 1973). These laboratories are eligible for claiming to Medicare for approved pathology services.
If suppliers need clarification on the operation of this exemption, please contact the TGA at COVIDtests@tga.gov.au or 1800 141 144.
Information for laboratories
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.
A laboratory that develops and uses Class 1-3 in-house IVDs must meet the following regulatory requirements:
- 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 the TGA 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 please go to the regulatory requirements.
Please contact us at COVIDtests@tga.gov.au or 1800 141 144 if you require further information on in-house IVDs.