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