Quality & Compliance: Update on the Australian Regulatory Landscape

Posted 01 July 2011 | By Valentina Theisz, MSc, RAC, FRAPS 

In the past, when asked about their experience with registering medical devices in Australia, most overseas regulatory professionals used to say that the process was lengthy and painful, and the local regulator, the Therapeutic Goods Administration (TGA), lacked transparency or was unresponsive. In recent years however, TGA has undergone dramatic changes.

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