I had to send through an email to the TGA today just to satisfy my own curiosity regarding the use of CareStart RAT when there is two separate sponsors. My email and the surprisingly quick response (same day) from the TGA below, if anyone is interested.
It is a bit of a shame that they have to assess each sponsored application individually even if the application uses an already approved medical device under a different sponsor. Though, I guess while the device might not be the issue they (TGA) still need to have an assurity that a sponsor has the appropriate channels for customer assistance for the use of the device. One would think AT1 could nearly do a copy and past from their HIV application with respects to consumer support and hotline services though?
TGA Response -
I had to send through an email to the TGA today just to satisfy...
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