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Australia's medical device reform proposals may lead to additional costs and administrative burdens for industry

This article was originally published in RAJ Devices

Executive Summary

There are some useful suggestions in the medical device regulatory reform package that Australia's Therapeutic Goods Administration put out for discussion in October 20101,2. Medical technology companies, however, are wary of the potential cost impact and added administrative burden that may come with many of the proposals. To that end, the Medical Technology Association of Australia has suggested solutions that will reduce these impacts while still assisting the TGA in meeting the objectives the government outlined in its Health Technology Assessment Review report released last year. The solutions, some of which are outlined in this article, form part of the MTAA's submission to the TGA on the proposals3,4.




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