TGA Requirements

#1
Hi all

Based on Clinical Decision Support Software TGA document, the software medical device is exempt to be approved by the TGA prior to supply and do not need to be included on ARTCG. I know there are other applicable requirements.
My question is, if the device moves to a higher classification from class I to class IIa (according to the changes of classification rule for software-based medical devices), is it required an inclusion on the ARTCG?

Thanks in advance
 
Elsmar Forum Sponsor

marmotte

Diapason Consulting
#2
1. -> exempt does not mean class I, it means exempt. That's another "class" in itself for CDSS. Note that it still needs a "notification" to the TGA
2. If the exemption rules do not work for your CDSS for some reasons and you end up with it being class IIa - then you have to include it in the ARTG, which in turns requires conformity assessment etc....Contact me if needs be Pierre @ Diapason Consulting | Linktree
 
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