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Legal supply of COVID-19 test kits

19 May 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.

There are two pathways to legally supply these types of tests:

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.

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 (Excluded Purposes) Specification 2010 and the Therapeutic Goods Advertising Code (No.2) 2018. For further guidance, read our warning to consumers and advertisers about COVID-19 test kits.

Testing for serious diseases, including COVID-19, should be conducted in conjunction 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.

Expedited TGA assessment of applications for COVID-19 tests

COVID-19 is an emerging viral infectious disease, so there is limited information available regarding the disease profile and the ability of available tests to accurately detect COVID-19 infections. 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 approval.

Additional conditions specific to serology COVID-19 point-of-care tests

Additional conditions are being imposed on the supply of serology-based COVID-19 tests for use at the point-of-care (i.e. serological rapid screening tests) 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.

Exemption for supply of COVID-19 tests to accredited pathology laboratories

An emergency exemption, Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020, has been made to allow rapid supply of COVID-19 diagnostic tests to all Australian accredited pathology laboratories. This emergency exemption allows COVID-19 diagnostic tests to be immediately supplied to accredited pathology laboratories.

Accredited pathology laboratories in this context are 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) and are eligible for claiming to Medicare for approved pathology services.

Note: The exemption only allows for the supply of COVID-19 tests, including serological rapid tests intended for use at the point-of-care, to the accredited pathology laboratories specified in the exemption. To supply COVID-19 tests more broadly will require inclusion of the device in the ARTG.

Note: Suppliers/importers that intend to supply a COVID-19 test to an accredited pathology laboratory must meet the conditions specified in the exemption.

If suppliers need clarification on the operation of this exemption, please contact the TGA at devices@tga.go.au or 1800 141 144.

Information for laboratories

COVID-19 in-house IVDs

In-house IVD medical devices used for COVID-19 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. 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:

Self-collected COVID-19 samples

Use of self-collected samples for SARS-CoV-2 also requires validation by the laboratory as an in-house IVD (if the test kit being used isn't validated by the manufacturer for use with these specimen types).

Laboratories need to be aware, that under the Therapeutic Goods Advertising Code, such COVID-19 collection kits cannot be advertised to consumers. If a laboratory advertises in-house self-collection testing kits to other healthcare professionals, then this is potentially considered supply of a commercial IVD, and as such, may require an ARTG entry.

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.