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COVID-19 infections are diagnosed using tests that are in vitro diagnostic medical devices (IVDs). To ensure that the COVID-19 health response is well informed, the Therapeutic Goods Administration (TGA) is working with IVD suppliers to ensure that the tests used in managing this pandemic are able to accurately detect COVID-19 infections.
This is current advice relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections. However, as the COVID-19 situation is changing rapidly, this advice may change. Please contact us at firstname.lastname@example.org if you need further information.
On this page:Exemption allows for immediate supply of COVID-19 tests | Applications to supply COVID-19 tests will be prioritised | Suppliers new to the Australian market and regulations will be supported | More information
The Australian regulatory framework for medical devices allows National Association of Testing Authorities (NATA) accredited laboratories to develop and use their own laboratory developed tests (referred to as 'in-house' IVDs), without requiring those tests to be included in the Australian Register for Therapeutic Goods (ARTG). This has enabled Australian laboratories to immediately develop COVID-19 tests based on internationally available COVID-19 genomic information and to commence testing.
To support a rapid COVID-19 response, tests used to test for COVID-19 (COVID-19 tests) will be exempt from particular requirements of the Therapeutic Goods Act 1989. This emergency exemption allows commercial suppliers of COVID-19 tests to immediately supply their tests to laboratories within the Australian Public Health Laboratory Network (PHLN). Because the PHLN is well integrated in state and territory public health systems, this will help facilitate reporting, recording and tracing of the spread of COVID-19 infections.
Please note the exemption does not allow for general supply of rapid tests, including serological rapid tests intended for use at the point of care, other than to the laboratories specified in the exemption.
The TGA is fielding a large number of enquiries from commercial suppliers of COVID-19 tests. Some of these suppliers are well known in Australia and have well-established supply networks and relationships with pathology providers and laboratories. Other suppliers are new to the Australian market and are navigating our regulatory system for the first time.
We are committed to supporting suppliers in their understanding of the Australian requirements for the supply of accurate COVID-19 tests.
We encourage suppliers who are familiar with the Australian regulatory requirements to submit an application for inclusion of their COVID-19 tests on the ARTG. All applications in relation to COVID-19 tests are being expedited as a matter of priority in assessment queues, and further prioritisation of particular COVID-19 tests will be guided by advice from the Chief Medical Officer, the Office of Health Protection (OHP) and the PHLN.
To ensure applications are assessed rapidly, we are encouraging sponsors to contact us through email@example.com and immediately provide supporting technical files/data for assessment. We understand that many of these tests are being moved to market very quickly and that some supporting information, such as real-time stability studies, will not yet be available. We will continue to work with sponsors to ensure that validation efforts continue, and will require sponsors to provide additional information over time.
The TGA will provide suppliers who are new to the Australian market with information on the Australian requirements for the supply of safe and accurate COVID-19 tests.
In the first instance, the TGA website has guidance for those new to Australian medical device and IVD regulation, which provides advice on the information that should be included in the technical files of an application. For further information on how to submit an application for inclusion of a COVID-19 test on the ARTG, please contact us at firstname.lastname@example.org.
A number of suppliers have asked questions about the current exemption for COVID-19 medical devices. The emergency exemption allows commercial suppliers to import and supply COVID-19 tests, which are not included on the ARTG, to laboratories that are state or territory members of the PHLN.
The classification rules for IVDs are provided in Schedule 2A of the Therapeutic Goods (Medical Devices) Regulations 2002. Currently the TGA is processing COVID-19/SARS-CoV-2 assays as Class 3 IVDs.
If you intend to submit an application for inclusion on the ARTG of an IVD for the detection of SARS-CoV-2, an appropriate level 3 Global Medical Device Nomenclature (GMDN) collective term in the TGA database is "Severe acute respiratory syndrome-associated coronavirus IVDs" CT772.
The TGA provides sponsors with guidance on how to include an IVD medical device on the ARTG, including:
The TGA publishes information on the current fees and charges for therapeutic goods. The fees to include a Class 3 IVD medical device on the ARTG for the 2019/20 financial year is as follows:
Regulation 5.3(1)(j) of the Therapeutic Goods (Medical Devices) Regulations 2002 prescribes the kind of IVD medical device that is required to be selected for audit. All applications for inclusion of IVDs intended for use at the point of care are subject to mandatory audit.
In-house IVDs used for COVID-19 testing (i.e. assays that are developed and validated within a laboratory, rather than supplied by a commercial manufacturer) can be developed by laboratories under the NATA/National Pathology Accreditation Advisory Council (NPAAC) arrangements.
Such in-house assays will need to be notified to the TGA under the in-house IVD regulatory scheme, but they do not require inclusion on the ARTG. Both PHLN and non-PHLN laboratories can legally develop and use in-house COVID-19 assays under the current regulatory requirements, and there is no need for an exemption in relation to these in-house IVDs.
IVDs that are identified by the manufacturer as being intended for Research Use Only (RUO) are not regulated by the TGA. However, laboratories are able to validate such RUO products for use as in-house IVDs.
Testing for serious infectious diseases is best conducted in conjunction with a healthcare professional who can provide appropriate advice and treatment if required. In Australia, the supply of self-tests for most serious infectious diseases, including self-tests for COVID-19, is prohibited under the Therapeutic Goods (Excluded Purposes) Specification 2010.
To keep up to date with the latest developments in relation to COVID-19, visit the coronavirus (COVID-19) health alert page on the Department of Health website.
The TGA has a response to the COVID-19 page which is updated as new information becomes available.
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