Australia’s TGA Releases Guidance on Self-Test In Vitro Diagnostics

April 13, 2021

Australia’s Therapeutic Goods Administration (TGA) has published its expectations for devicemakers developing in vitro diagnostic (IVD) self-tests for infectious diseases such as influenza, hepatitis B and C, chlamydia, gonorrhea and syphilis.

In 2010, the TGA prohibited self-testing IVDs to be sold to consumers, but the agency now plans to allow certain self-test devices to be sold in the country, although it will still prohibit self-tests for cancer and genetic testing.

The agency has released guidance outlining performance requirements and risk mitigation strategies for different types of self-tests. Devicemakers will need to submit applications to the TGA to show that their IVDs are in compliance with regulations and that risk mitigation strategies are in place.

View today's stories