In-vitro diagnostic (IVD) medical devices are regulated in Australia by the Therapeutic Goods Administration (TGA) having regard to the risks (to the individual or public health) in the context of the device’s intended use. All devices carry some level of potential risk, and the TGA applies scientific and clinical expertise to ensure there is a balance between the benefits and the risks.
An Action Plan for Medical Devices is a three-part strategy to strengthen Australia’s regulatory system while continuing to be patient focused and have greater transparency. It outlines actions that continue to improve the safety, performance and quality of medical devices in Australia and improve health outcomes for patients who require medical devices…
