Just to play devil's advocate, Atomo diagnostics has been trying to get TGA approval for HIV self testing for years.
Could public pressure have played a role? it seems frustrating that the Australian process is so difficult for medical devices.
In 2020 the house of representatives had an independent inquiry into approval processes for drugs.
The inquiry found there was a need to "strengthen the TGA by having a more proactive, outward-looking approach." 11 Oct 2020.
Separate to AT1, I think consumer pressure on the TGA to be more proactive in general is not a bad thing, at all levels.
Look at how slow Australia was to adopt rapid testing.
By the way ( off topic ) antibody tests are now done for all in-bound passengers in China.
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