Regulation of Medical Devices - Commercial IVDs

The Regulation of Medical Devices requires all commercial suppliers of In-vitro diagnostics (IVDs) to register their IVDs with the TGA before 1 July 2015. If a commercial supplier does not register with TGA they will not be able to legally supply their IVD in Australia after 30 June 2015.

It is recommended that in order for laboratories who are reliant on such devices to have confidence in the ongoing availability of their IVDs that they request that their supplier confirms they intend to transition the IVD and include it in Australian Register of Therapeutic Goods (ARTG). The laboratory should be aware that if the supplier does not intend to transition the IVD, the laboratory is still able to use existing stock after 30 June 2015 (i.e. this is stock that was purchased before 30 June 2015), which should allow time for an alternative to be sourced.

If you should have any questions in this area it is advised that you contact the TGA directly via email through This email address is being protected from spambots. You need JavaScript enabled to view it.