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Australian device legislation

This article was originally published in The Gray Sheet

Executive Summary

Therapeutics Goods Administration is working with the Medical Industry Association of Australia to hold a series of workshops in late May and early June to educate industry on the new regulatory framework slated for implementation as early as the second half of 2002, according to a 1TGA release. The Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Charges) Amendment Bill were passed by the Australian Parliament March 21. The framework set out in the bills is based on Global Harmonization Task Force guidelines (2"The Gray Sheet" Nov. 26, 2001, p. 18)...

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