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Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG
25 August 2021
COVID-19 infections are diagnosed using tests called in vitro diagnostic medical devices (IVDs). The Therapeutic Goods Administration (TGA) is working with IVD suppliers to ensure that there are tests available to support efforts in managing the COVID-19 emergency.
This page provides information for sponsors (i.e. suppliers/importers) that wish to submit an application for expedited TGA assessment for inclusion of a COVID-19 test in the Australian Register of Therapeutic Goods (ARTG). Sponsors are encouraged to review the information on this page in conjunction with the Legal Supply of COVID-19 test kits page.
Note: This is current advice relating to the inclusion of COVID-19 tests in the ARTG. 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.
Applications to supply COVID-19 tests will be prioritised
We encourage sponsors to submit an application for inclusion of their COVID-19 tests in the ARTG.
Please note that sponsors are not required to request or submit a priority review as all applications in relation to COVID-19 tests are already being expedited as a matter of priority in assessment queues. Further prioritisation of particular COVID-19 tests will be guided by advice from the Chief Medical Officer, the Office of Health Protection and the Public Health Laboratory Network.
Process for applying for inclusion of a COVID-19 test in the ARTG
The TGA will provide sponsors who are new to the Australian market with information on the regulatory requirements for the inclusion of COVID-19 tests in the ARTG.
As a potential sponsor of a COVID-19 test kit, you will need to submit and have your manufacturer's evidence (conformity assessment certification) accepted by the TGA prior to being able to submit your IVD application. Once an IVD application is submitted and the application fee paid, the TGA will contact you and advise what information you will be required to supply.
In the first instance, the TGA website provides guidance on the information that should be included in the technical files of an application and a step-by-step guide to the ARTG inclusion process:
- Medical device inclusion process - step-by-step guide
- Overview of medical devices and IVD regulation.
Please note, based on experience gained from the post market review of serology-based COVID 19 point-of-care devices, the TGA expects clinical performance studies to be provided that clearly demonstrate the sensitivity of the device according to:
- the immunoglobulin type (e.g. IgG, IgM and combined IgM, IgG); and
- the days post onset of symptoms.
This information also needs to be included in the instructions for use (IFU) provided with the device so that the user can make an informed decision about how to interpret the results taking into consideration the clinical presentation of the patient and the time since the onset of symptoms. Clear warnings need to be provided in the IFU about the potential for negative results if testing is performed in the acute phase of infection and the need for further laboratory testing.
The TGA may request further information throughout the assessment process. We understand that many of these tests are being developed very quickly and that some supporting information, such as real-time stability studies, may not yet be available.
Note: Please note an application will not be progressed nor a decision made until the associated application and audit fees have been paid.
Note: A COVID-19 test can only be supplied once a sponsor receives a notice of the ARTG inclusion entry number.
The ongoing responsibilities of sponsors are described further in the Australian Regulatory Guidelines for Medical Devices (ARGMD). We encourage all sponsors of COVID-19 tests to review this information.
Note: We are committed to supporting sponsors in their understanding of their regulatory requirements for the supply of COVID-19 tests. Please contact us at COVIDtests@tga.gov.au or 1800 141 144 if you have any questions regarding this process.
Conditions on all COVID-19 tests approved for ARTG inclusion
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 device be provided to the TGA within 12 months of approval. The TGA will advise sponsors when additional evidence is required to be provided.
Additional conditions specific to COVID-19 serology and rapid antigen point-of-care tests
Additional conditions are imposed on the supply of COVID-19 serology-based tests and rapid antigen (viral protein) 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.
The correct interpretation of test results in conjunction with the clinical presentation of a patient is critical to informing patient management and minimisation of further transmission of the virus. Accurate identification of a COVID-19 infection based on results obtained from serology-based and rapid antigen point-of-care tests requires testing by suitably qualified persons with an understanding of how the viral infection develops, the different stages of infection and subsequent antibody response profile.
The misinterpretation of serology-based and rapid antigen point-of-care test results presents a grave risk to public health, which could result in serious illness and death of the patient and other persons that the patient comes into contact with. Testing for COVID-19 should be conducted in conjunction with an appropriate healthcare professional who can provide an individual with appropriate advice and treatment.
Transmission-based precautions must also be used when collecting specimens from patients with a communicable disease, which should be regarded as potentially infectious not just for SARS-CoV-2 (the virus that causes the disease called COVID-19), but also for other infectious diseases. Staff must be trained in appropriate specimen collection and infection control procedures.
For these reasons, the additional non-standard conditions of inclusion in the ARTG apply to serology-based and rapid antigen point-of-care tests for COVID-19:
Conditions specific to COVID-19 serology point-of-care tests
Conditions specific to COVID-19 rapid antigen point-of-care tests
For the non-standard conditions of inclusion in the ARTG see COVID-19 rapid antigen point-of-care tests .
Q&A - Conditions of supply for rapid antigen tests
We have developed a number of questions and answers to provide information about what tests are approved, and the supply and use of these tests.
Post-market review of serology COVID-19 point-of-care tests
A post-market validation is being performed on all TGA approved serology COVID-19 point-of-care tests. Upon approval, sponsors will be required to provide samples to the TGA for validation.
The TGA will advise sponsors when samples are to be sent for validation. For further information, see Post-market review of COVID-19 point-of-care tests.
More information
COVID-19 IVD classification and GMDN collective term
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 in the ARTG for a COVID-19 IVD, an appropriate level 3 Global Medical Device Nomenclature (GMDN) collective term in the TGA database is "Severe acute respiratory syndrome-associated coronavirus IVDs" CT772. If your device is for multiple pathogens your application may require a different GMDN term. Please contact us at COVIDtests@tga.gov.au or 1800 141 144 for further information.
Conformity Assessment (Manufacturer's evidence)
For Class 3 IVDs, manufacturers are required to implement a full quality management system (QMS) that includes design and development (i.e. not just manufacture or production) - refer to schedule 3, part 1, clause 1.1 of the Therapeutic Goods (Medical Devices) Regulations 2002. Full quality management system assessment to the requirements of ISO 13485:2016 would include assessment to Clause 7.3 for Design and Development.
The QMS certificate needs to be issued by an acceptable certification body. The manufacturer's scope of QMS certification also needs to cover manufacture of the kind of device being applied for. If the scope is not clear, the TGA may request a copy of the QMS audit report to confirm whether a manufacturer's certification covers the manufacture of a particular type of COVID-19 test.
Further guidance on acceptable evidence can be found on the TGA website.
Associated fees for a Class 3 IVD
The TGA publishes information on the current fees and charges for therapeutic goods. The fees to include a Class 3 IVD medical device in the ARTG for the 2019/20 financial year are as follows:
- Application fee - $1,070
- Audit assessment fee (if the TGA requires the IVD to be selected for mandatory audit) - $7,200
- Annual charge - $700.
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.
COVID-19 updates
The TGA has a Coronavirus (COVID-19) information page which is updated as new information becomes available.
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.