The proposed IVD regulatory framework - overview and fees and charges

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).

It is proposed that the new regulatory framework for IVDs will be introduced during 2009. Information on the proposed new regulatory requirements will be made available in regular updates over the next few months.

An Overview of the proposed new framework <http://www.tga.gov.au/ivd/overview.htm> is now available, together with a summary of proposed fees and charges <http://www.tga.gov.au/ivd/propfees.htm>. A list of Frequently Asked Questions (FAQs) on the fees and charges has been prepared.

The Therapeutic Goods (Medical Device) Regulations 2002 are currently being redrafted to include provision for IVDs. Once the new draft Regulations are available, the TGA will be organising information sessions for stakeholders. To register your interest in these sessions, you should email your contact details (Company Name / Name / address / telephone / email) to ODBTConsult@tga.gov.au, including the words "IVD contact list" in the title of your email.

For further information please contact Shelley Tang, Director, IVD Framework Development Taskforce, Office of Devices, Blood and Tissues by email at shelley.tang@tga.gov.au or phone 02 6232 8793.