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Ann: TGA Registration Update, page-302

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inv2013

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18/12/21

08:47

Post #: 58381845
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Originally posted by RandomGuy01: ↑

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.

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@RandomGuy01 Thank you for the answer. I see in the list a Newcastle company had to get approval for patient bed scales. TGA are examing everything, no wonder they are so busy.

ADO Price at posting: 19.0¢ Sentiment: Hold Disclosure: Held
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