Here is a collection of tools and resources for manufacturers and sponsors about COVID-19 rapid antigen tests.

Legal supply of COVID-19 test kits

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. One exception to this is for Class 4 in-house IVDs being used to perform donor screening under the emergency exemption.

All importers of COVID-19 test kits must apply for, and be granted, an import permit for all consignments of COVID-19 test kits that are imported into Australia, unless the importer can demonstrate that the goods are for personal use only or are entirely synthetic.

To apply for an import permit, please refer to BICON import permits.

COVID-19 test kits included in the ARTG for legal supply in Australia

All COVID-19 test kits approved by the TGA for inclusion in the Australian Register of Therapeutic Goods (ARTG) are listed on the COVID-19 test kit page.

To find approved rapid antigen test for use at the point-of-care under the supervision of a relevant health practitioner, select 'Point-of-care test' under 'show only' and sort by 'Point of care test'.

To find approved self-tests, select 'Self-test (home use test)' under 'show only' and sort by 'Point of care test or Self-test'.

Applying for TGA approval to supply a COVID-19 test in Australia

Information for sponsors (i.e. suppliers/importers) that wish to submit an application for TGA assessment for inclusion of a COVID-19 test in the Australian Register of Therapeutic Goods (ARTG). Sponsors are encouraged to review this information in conjunction with Legal supply of COVID-19 test kits.

Expedited COVID-19 medical device application process

The Therapeutic Goods Administration (TGA) is currently undertaking an expedited assessment process for all medical devices associated with the detection, prevention and treatment of COVID-19. We are committed to supporting suppliers with the Australian requirements and encourage potential suppliers to submit an application for inclusion on the Australian Register of Therapeutic Goods (ARTG). 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.

We are committed to supporting sponsors to understand the Australian regulatory requirements for the supply of COVID-19 related medical devices, including test kits.

Manufacturing medical devices for COVID-19 including 3D printing

We have published guidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.