ABSTRACT
Healthcare provision in Australia is made up of public and private funding: Public expenditure is funded by the Commonwealth Government under a health care system called Medicare: Australia’s universal, tax-financed insurance scheme covering medical, pharmaceutical, and public hospital services. Private expenditure is largely funded through insurance. However, Medicare also pays 75% of the schedule fee for services and procedures provided in private hospitals. In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA). The body responsible for regulating medical devices in Australia is the Office of Devices Authorisation, within the Therapeutic Goods Administration (TGA). The TGA is a division of the Australian Government Department of Health and Ageing. Medical devices are classified on the basis of risk, through consideration of the manufacturer’s intended use, degree of invasiveness in the human body, and duration of use.
