Medical devices reforms: review of the regulation of certain self-testing in vitro diagnostic medical devices in Australia

Project overview

The supply of home-use tests, also known as self-tests for serious diseases, has not been allowed in Australia since 2010 under the Therapeutic Goods (Excluded Purposes) Specification 2010. 

The exception is self-tests for Human Immunodeficiency Virus (HIV), which have been permitted since 2014.

In accordance with the Legislative Instruments Act 2003, the Excluded Purposes Specification 2010 expired on 1 October 2020. 

It was a legal requirement to perform a review prior to the remaking of the instrument to see if there was a continuing need for this regulation and if any prohibitions should be maintained. 

As such, the TGA sought feedback from industry, clinical experts, consumer groups and other stakeholders on whether these prohibitions should remain or whether a wider range of self-tests should be allowed in future.

Following consultation, the Therapeutic Goods (Excluded Purposes) Specification 2020 has been remade to allow a limited number of self-tests to be made available in Australia where there are particular benefits to public or individual health and the tests can be made safely available. 

This includes self-tests for hepatitis B and C viruses, some sexually transmitted infections, seasonal influenza and some other serious non-infectious conditions such as diabetes, kidney disease and cardiovascular disease. 

This new instrument came into effect on 1 October 2020.

Self-tests for other serious diseases and infectious diseases, including cancer and genetic self-tests, will continue to be prohibited from supply.

Guidance for industry

For guidance on IVD medical devices and information on the consultation on self-tests see:

• Chlamydia, gonorrhoea and syphilis IVD self-tests: Clinical performance requirement and risk mitigation strategies
• Seasonal Influenza IVD self-tests: Clinical performance requirement and risk mitigation strategies
• Hepatitis B and C viruses IVD self-tests: Clinical performance requirement and risk mitigation strategies
• IVD self-test consultation summary and outcomes
• IVD guidance documents
• Clinical evidence guidelines: Medical Devices

Consultations