The Australian medical device regulatory system implemented 4 October 2002
General overview of the new legislation
The new regulatory system for medical devices in Australia came into effect on 4 October 2002. The new system puts Australia at the forefront of world's best practice for the regulation of medical devices. Australia has adopted the international regulatory model developed by the Global Harmonization Task Force.
With the new system comes the world's first web based electronic application lodgement system. Additionally, the recently developed international standardised device nomenclature system known as the Global Medical Device Nomenclature System (GMDNS), is used to categorise devices on the Australian Register of Therapeutic Goods (ARTG).
Transition period
2 year transition period
The transitional arrangements for the implementation of the new regulatory system included a two year transition period for devices that met the definition of a medical device but were exempt from entry on the ARTG or were excluded under the Therapeutic Goods (Excluded Goods) Order of 1998.
The two-year transition period for exempt and excluded goods ended on 4 October 2004. All previously exempt and excluded products that meet the definition of a medical device will now have to be included on the ARTG and meet the requirements of the new system.
5 year transition period
Sponsors of medical devices that were on the ARTG as registered or listed devices as at 4 October 2002 have until 4 October 2007 to demonstrate their products meet the new regulatory requirements. Once a device has been entered on the ARTG under the new system, all entries for that particular device as a listed or registered device will be cancelled.
Device electronic application system (DEAL)
The new DEAL system <http://www.tga.gov.au/online/deal.htm> is now operational to handle on line electronic applications for the inclusion of all classes of medical devices onto the ARTG. DEAL can also be used to lodge an application for ARTG entry for the listable products that have a two year exemption from meeting the new requirements mentioned in the paragraph above. Applications for both registration and listing on the ARTG for Other Therapeutic Goods (such as in-vitro diagnostics, hospital/household/commercial disinfectants, devices containing product of human origin) can also be lodged through DEAL. For access queries contact:
Telephone: 1800 010 624
Facsmile: 02 6232 8581
Email ebs@tga.gov.au
Information on the new system
To assist with the transition to the new regulatory system, an Information Unit has been established to handle general information enquiries. The contact details are:
Telephone: 1800 141 144
Facsimile: 02 6232 8299
Email: cab.medical.device.information@tga.gov.au