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Australia issues new medical device guidance document:

This article was originally published in Clinica

Executive Summary

The Australian Therapeutic Goods Administration (TGA) has issued a guidance document, which is part of a series aimed at explaining the new regulatory system for medical devices in Australia, introduced in October 2002. The document outlines the obligations and responsibilities of sponsors and manufacturers of medical devices after they have been approved for distribution nationally. Manufacturers must maintain technical documentation that demonstrates that their products conform to the essential principles of quality, safety and performance. They must further provide evidence that the appropriate conformity assessment procedure has been applied. This data must be made available upon request by the TGA. In addition, sponsors must have access to this evidence and be able to provide it on request. The document can be downloaded at: http://www.health.gov.au/tga/docs/pdf/devguid11.pdf

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