Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG
Information for sponsors regarding the supply of COVID-19 tests, including advice for those sponsors new to therapeutic goods regulation in Australia.
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 tests are available to help manage the COVID-19 pandemic.
This page provides information for sponsors (i.e. suppliers or importers) that wish to include a COVID-19 test in the Australian Register of Therapeutic Goods (ARTG). Sponsors are encouraged to review the information on this page and on the Legal Supply of COVID-19 test kits page.
The TGA will prioritise applications for combination or multiplex (COVID/FLU) tests
The TGA must prioritise applications based on the public health need. We prioritised COVID-19 tests, including COVID-19 Rapid Antigen Tests (RATs), throughout 2022 and we continue to prioritise all COVID-19 tests. Over 700 COVID-19 test applications have been processed and finalised, however, several hundred applications remain on hand. Find COVID-19 self-tests approved for supply in Australia.
During 2022, our focus needed to shift to tests that detect both Influenza virus and COVID-19. For many consumers, distinguishing between COVID-19 and Influenza is important in managing their infections. For combination or multiplex (COVID/FLU) tests, sponsors do not need to ask for priority review as we are already prioritising these applications at the top of the queue of COVID-19 test applications.
Process to apply to include a COVID-19 test in the ARTG
The TGA will give sponsors who are new to the Australian market information on the regulatory requirements for COVID-19 tests. Additional information is available for manufacturers and sponsors of rapid antigen self-tests (for home use)
As a potential sponsor of a COVID-19 test, you will need to first submit and have your Manufacturer's Evidence (conformity assessment certification) accepted by the TGA before you can submit your COVID-19 test application. Once you then submit your COVID-19 test application and pay the application fee, the TGA will contact you and advise what information you need to supply.
The TGA website explains the information that should be included in the technical files to support 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.
Note: Please note an application will not be progressed nor a decision made until both the application fee and application audit fee have been paid.
Note: A COVID-19 test can only be supplied once a sponsor receives a notice of the ARTG inclusion entry number.
All sponsors of COVID-19 tests included in the ARTG have ongoing responsibilities under the Therapeutic Goods Act 1989, the Medical Device Regulations and the Therapeutic Goods Advertising Code (the Advertising Code), including conditions that apply automatically to all ARTG entries. We encourage all sponsors of COVID-19 tests to review this information.
Note: We are committed to supporting sponsors to understand the regulatory requirements for COVID-19 tests. Please contact us at COVIDtests@tga.gov.au or 1800 141 144 if you have any questions about this process.
Additional conditions for COVID-19 serology, rapid antigen point-of-care and self-tests, and combination (COVID/FLU) self-tests
Additional non-standard conditions are imposed on the supply of COVID-19 serology point-of-care tests and rapid antigen (viral protein) tests for use at the point-of-care and self-testing.
- see COVID-19 point-of-care tests for conditions on COVID-19 serology point-of-care tests and COVD-19 rapid antigen point-of-care tests
- see COVID-19 rapid antigen self-tests (for home use) for conditions on COVID-19 rapid antigen self-tests and combination (COVID/FLU) self-tests.
Post market review of COVID-19 serology point-of-care tests and rapid antigen tests
The TGA is performing a post market review of all approved COVID-19 tests, including serology-point of care tests, nucleic acid tests (NAT) and rapid antigen tests (POC and self-tests) to verify their performance. The Peter Doherty Institute for Infection and Immunity (the Doherty Institute) has been engaged by the Department of Health and Aged Care to assist with the post-market verification process of some of these categories of tests (serology point of care tests and rapid antigen tests). However, reports by other Australian laboratories or comparable international regulators may also be taken into consideration.
As part of the post market review, the TGA may request additional evidence to demonstrate the continued performance of COVID-19 and combination tests against current and emerging COVID-19 variants.
COVID-19 test classification and GMDN collective term
The classification rules for IVDs are provided in Schedule 2A of the Therapeutic Goods (Medical Devices) Regulations 2002. COVID-19 and combination tests are Class 3 IVDs.
If you intend to apply to supply a COVID-19 test, an appropriate level 3 Global Medical Device Nomenclature (GMDN) collective term in the TGA database is "Severe acute respiratory syndrome-associated coronavirus IVDs" CT772 and if your device is for detection of multiple viruses it is "Multiple-viruses IVDs" CT702. 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 must 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 QMS assessment against ISO 13485:2016 includes assessment against 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.
Fees for a Class 3 IVD
The TGA publishes information on the current fees and charges for therapeutic goods.
Regulation 5.3(1)(j) of the Therapeutic Goods (Medical Devices) Regulations 2002 prescribes that the TGA must select certain IVD medical device applications for mandatory application audit and charge the associated application audit fee. This includes, for example, all IVD medical devices for self-testing or point-of-care testing.
For more information about rapid antigen tests visit COVID-19 tests.
For information on all the TGA's COVID-19 related work, please visit the COVID-19 hub.
Please see the Department of Health and Aged Care website for all COVID-19 updates.