Or perhaps in 2010...

TGA appears to have postponed implementation of the new IVD regulations into 2010.  This follows considerable difficulty with establishing a mechanism for dealing with the large bulk of IVDs used in Australia which are imported.  There's no equivalent of the CE certificate availabe for most of these devices - as the proposed TGA system captures many IVDs which are self certified in Europe.

For more information - come along to the IVds session at Ausbiotech 2009 to hear about the latest developments in Australia and internationally in IVD regulations.  Click here to download the full conference program.