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IVD medical devices regulations update, March 2010

16 March 2010

On 25 February 2010 the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (the MD Amendment Regulations) and the Therapeutic Goods Amendment Regulations 2010 (the TG Amendment Regulations) were made by the Governor-General. These Amendment Regulations were registered in the Federal Register of Legislative Instruments on 3 March 2010 and will commence on 1 July 2010. The MD Amendment Regulations and the TG Amendment Regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990, respectively.

The MD Amendment Regulations implement a new regulatory framework for in-vitro diagnostic medical devices (IVD medical devices or 'IVDs') under Chapter 4 of the Therapeutic Goods Act 1989 and provide for the transitioning, over a four-year period, from the current regulatory framework for IVDs to the new regulatory framework. The TG Amendment Regulations implement consequential amendments that reflect the changes in the regulatory framework applying to IVD medical devices.

Background to the new regulations

In August 2008, the new Australian government announced that the TGA would proceed with a number of regulatory reforms that had been proposed for implementation under the legislation establishing the Australia New Zealand Therapeutic Products Authority (ANZTPA). Since the establishment of ANZTPA did not proceed as expected, the TGA has continued to develop the proposals for regulatory reform in the context of the current legislation. One of these reforms is the introduction of a new regulatory framework for in vitro diagnostic devices (IVDs).

This new regulatory framework is needed as the current level of regulation of IVDs in Australia is limited. Currently, IVDs for testing for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) must undergo extensive pre-market review, and a small number of IVDs are required to undergo limited pre-market review. However, the majority of IVDs are not subject to pre-market regulatory scrutiny. The amended Regulations set out more comprehensive and consistent requirements for IVDs, including classifying IVDs according to their intended purpose and the public health and personal risks associated with their use.

The new regulatory framework for IVDs will also harmonise Australia's regulation of IVDs with those recommended by the Global Harmonisation Task Force (the GHTF), whose members include the five major regulatory jurisdictions: the United States of America, Europe, Canada, Japan and Australia.

Further information

The new regulations can be found on the Federal Register of Legislative Instruments: