I actually had a look at this a few days ago. Exports are class 1 regardless.
Covid tests are class 3 due to the risk factor to public and personal health."Moderate public health risk or high personal risk".
So the TGA considers covid a 'moderate' risk otherwise, the tests would be class 4.
https://www.tga.gov.au/sites/default/files/classification-ivd-medical-devices.pdf
If you look at tests approved here
https://www.tga.gov.au/covid-19-test-kits-included-artg-legal-supply-australia
And then search for them here
https://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artg
You'll find that they are class 3 if you look at their certificates.
Ann: TGA Registration Update, page-295
-
- There are more pages in this discussion • 2,123 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
