Overseas collaboration with Therapeutic Devices Branch

Liaison and cooperation with other regulatory bodies are important aspects of the Therapeutic Devices Branch's operation. As the Therapeutic Devices Branch (TDB) has comparatively few resources, it is important to minimise duplication between other regulatory bodies and to benefit from each other's work. Most companies also wish to market products internationally and it is vital, particularly for relatively small markets, that regulatory requirements are consistent. This helps reduce the need for costly product or packaging modifications and ensures useful new medical technology can enter the market quickly and at a reasonable cost.

A major step was taken recently in establishing better working arrangements between the United States' Food and Drug Administration (FDA) and TDB, with a visit from Dr Bruce Burlington and the exchange of staff between January and May 1995. Dr Bruce Burlington, the Director of the FDA's Centre for Devices and Radiological Health, recently visited the TDB at Symonston to discuss issues relating to the regulation of devices.

Kathy Mitrangas, a principal evaluator in the TDB and Janine Morris from the FDA have literally swapped their working lives as they learn how the other organisation operates. The TDB's Director, Dr Derrick Beech, says "this exchange promises to be an exciting opportunity for both organisations to develop a better understanding of each other".

Dr Xi Ting Fei also visited TDB for three months from Beijing, where he is the Director of the Centre of Medical Devices of the National Institute for the Control of Pharmaceutical and Biological Products. His visit will provide a greater mutual understanding between China and Australia about therapeutic device regulation. Dr Xi is also working on a collaborative research projects such as the degradation of polyurethanes in the body.

Dr Urusa Intrasuksri is visiting the Branch from the Division of Drug Analysis of the Thailand Department of Medical Sciences. Dr Intrasuksri is a pharmacist, and also has a PhD in Pharmacology from Ohio State University. She will learn about cytotoxicity testing of plastics with TDB, and will also study quality control, regulation and testing of recombinant products, as well as LAL testing with TGAL.