The Therapeutic Goods Administration (TGA) is working with suppliers 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), in order to 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.

Priority TGA assessment of applications for COVID-19 tests

With the recently amended Therapeutic Goods (Medical Devices - Excluded Purposes) Specification 2020 enabling applications for COVID-19 rapid antigen self-tests to be submitted and reviewed for potential approval by the TGA, this together with COVID-19 point-of-care tests, remains the Government's highest priority.

For further information, see Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG.

Conditions imposed on all approved COVID-19 tests

Since the early stages of the pandemic, all COVID-19 tests that are included in the ARTG, including those 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 as knowledge and experience around COVID-19 diagnostic testing grows.

The conditions require that additional evidence to support the ongoing safety and performance of the devices be provided to the TGA within 12 months of inclusion on the ARTG.

Additional conditions specific to COVID-19 serology and rapid antigen tests for use at the point-of-care

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. As it is considered that the correct interpretation of results obtained from these tests requires the involvement of a suitably trained 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.

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. Further information on the ongoing obligations and responsibilities of a sponsor of a COVID-19 test kit included in the ARTG can be found via the Australian regulatory guidelines for medical devices.

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.

Changes to the exemption for supply of COVID-19 tests to accredited pathology laboratories

The emergency exemption that allowed COVID-19 diagnostic tests to be immediately supplied to accredited pathology laboratories ceased on 31 July 2020. Such a broad emergency exemption is no longer needed as there are sufficient numbers of IVD medical devices for diagnosing COVID-19 infections included in the Australian Register of Therapeutic Goods (ARTG).

Instead, a new emergency exemption, the Therapeutic Goods (Medical Devices - Donor Screening) (COVID-19 Emergency) Exemption 2021 which is more limited in application, has been made to enable the continued use of COVID-19 tests by accredited pathology laboratories (as Class 4 in-house IVDs) for the purpose of donor screening. The new emergency exemption will have effect until 30 June 2022.

Tests that are intended to be used to screen donors of blood, tissues, organs etc for COVID-19 are Class 4 IVD medical devices. There are no commercially available Class 4 IVD medical devices included in the ARTG for this purpose. Laboratories are currently using their own tests, or 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 require inclusion in the ARTG. Due to the lack of commercially available COVID-19 tests for donor screening, the new exemption will allow the continued use of Class 4 in-house IVD medical devices by accredited pathology laboratories for this purpose.

The reference to accredited pathology laboratories 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) 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.