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Regulatory Framework * Medical Devices

Medical devices are regulated by the Office of Devices, Blood and Tissues (ODBT) of the TGA. The regulations for medical devices are modelled on the recommendations of the Global Harmonisation Task Force and there is a Mutual Recognition Agreement with the European Union. Every medical device requires clinical evidence, appropriate for the use and classification of the device that demonstrates the device conforms to the applicable provisions of the essential principles of the ODBT/TGA.  For more information, visit the TGA.

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