Hi All,
For a Class 2 and 3 IVDs with Australia's TGA approval, if we include additional sample or specimen type, will it require any updated STED file submission to TGA and seek approval before selling it or just a change notification will do?
Thanks,
Sreenu
For a Class 2 and 3 IVDs with Australia's TGA approval, if we include additional sample or specimen type, will it require any updated STED file submission to TGA and seek approval before selling it or just a change notification will do?
Thanks,
Sreenu