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Legal supply of COVID-19 test kits

8 October 2020

The Therapeutic Goods Administration (TGA) is working with suppliers to ensure that Australia has tests available to support efforts in managing the COVID-19 emergency.

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.

Note: The emergency exemption that previously allowed supply of COVID-19 tests directly to accredited pathology laboratories ended on 31 July 2020. All COVID 19 tests must be included in the ARTG prior to supply, with the exception of Class 4 in-house IVDs being used to perform donor screening under the new 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 devices@tga.gov.au or 1800 141 144 if you need further information.

Expedited TGA assessment of applications for COVID-19 tests

The TGA is currently undertaking an expedited assessment process based on the information and performance data available at the time of application for inclusion in the ARTG.

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

Note: All applications in relation to COVID-19 tests are being expedited as a matter of priority.

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 devices@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 are subject to additional non-standard conditions, that inform post-market validations as experience and knowledge 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 qualified healthcare professional.

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

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.

Note: The supply and advertising of COVID-19 tests to consumers for home use (self-tests) is prohibited in Australia under the Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020 and the Therapeutic Goods Advertising Code (No.2) 2018. For further guidance, read our warning to consumers and advertisers about COVID-19 test kits.

Note: Under the Therapeutic Goods Advertising Code, COVID-19 self-collection kits cannot be advertised to consumers.

Testing for COVID-19 should be conducted in consultation with a medical practitioner who can provide appropriate advice and treatment. 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: Some states and territories have prohibited or restricted use of serology rapid screening tests. Please visit the South Australian, Western Australian and Queensland government websites for further information.

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 2020 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 2021.

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 devices@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:

Use of alternative COVID-19 samples

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.

Note: Clause S1.3 of the NPAAC standard, Requirements for the development and use of in-house in vitro diagnostic medical devices, allows for immediate testing using an in-house IVD that cannot be fully validated in circumstances where the test is required as a matter of urgency for a disease that poses a serious risk to public health. It is a condition of clause S1.3 that laboratories need to have a documented plan for continuing to work towards validation and have validation records available (to the extent possible in the circumstances).

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

Please contact us at devices@tga.gov.au or 1800 141 144 if you require further information on in-house IVDs.