Life sciences companies looking to make therapies and medical devices available in Australia are urged to learn about the Therapeutic Goods Administration (TGA) regulations. This page gives an overview of the TGA, details its approach to regulation and provides tips for achieving compliance.
Part of the TGA’s medical device regulations includes a comprehensive adverse event reporting program. This involves assessing the evidence of the risks compared to the benefits. For instance, how likely is the device to fail either accidently or deliberately? Given the variety of device types and purposes, all risks must be identified and managed according to the nature of the device.
According to Australian regulatory guidelines, health care-related products are expected to consistently maintain a high standard of quality throughout their life cycle. Once a product is approved, the agency continues to monitor it through various vigilance activities. This means manufacturers should pursue postmarket quality management and continuous improvement.
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