What was the medical device transition?

29 October 2007

A new regulatory framework for medical devices was introduced in October 2002, with a five year transition period ending on 4 October 2007.

The new system was introduced with the support of the medical device industry as it moved Australia to an internationally harmonized regulatory framework consistent with the outcomes from the Global Harmonization Task Force for medical devices (GHTF).

The new requirements for medical devices differ significantly from those that applied to "registered" and "listed" therapeutic devices under the old framework.

At the time agreement was given by the Australian Government for a new framework to be developed, the decision was taken that there would be no grandfathering of therapeutic devices already marketed in Australia.

As a result all "registered" and "listed" therapeutic devices affected by the transition require an application for inclusion onto the ARTG as "individual" medical devices under the new framework by the TGA and subsequent re-entry in the Australian Register of Therapeutic Goods (ARTG) as "included" medical devices. The new requirements for medical devices are set out in Chapter 4 of the Therapeutic Goods Act 1989 and in the Therapeutic Goods (Medical Devices) Regulations 2002.

Those previously registered and therapeutic devices affected by the transition for which an effective application for either inclusion in the ARTG or TGA Conformity Assessment certification was not lodged with the TGA by end of 3 October 2007 are taken to have been cancelled by 4 October 2007, and are no longer able to be supplied commercially in Australia.