This appeared last week:
15 March 2021
TGA software crackdown
Podcast Technology TGA The Tea Room
The Therapeutic Goods Administration recently announced changes to the regulation of ‘software as a medical device.’
The changes apply to software which has a purpose consistent with the definition of a medical device such as diagnosis, prevention, monitoring, prediction, prognosis or the treatment of a disease or disability.
And since the end of February, any products not listed on the Australian Registry for Therapeutic Goods (ARTG) have been prevented from being sold in Australia.
This new guidance clarifies the regulatory landscape for software based digital health products, and will work to distinguish certain products that are considered low risk, from ones that are subject to additional oversight.
Here is the website link and access to the podcast (18 mins)
https://medicalrepublic.com.au/tga-software-crackdown/41788
Pity there was not a bit more clarity about just what the ‘carve outs’ are and how they are to be understood – but a worthwhile listen!
The speaker is Bronwyn Le Grice From ANDHealth.
David.
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