On 29 June 2012, the Parliamentary Secretary for Health and Ageing announced that hip, knee and shoulder implants will be reclassified as high risk medical devices from 1 July 2012. The reclassification is in response to recommendations of the Health Technology in Australia Review and following concerns over the quality of recent implants that have been recalled. Manufacturers and suppliers of new hip, knee and shoulder implants will need to apply to the Therapeutic Goods Administration for inclusion on the Australian Register of Therapeutic Goods as high risk medical devices. Manufacturers and suppliers of existing hip, knee and shoulder joint implants will have two years to transition these devices to the new regime. A Regulation Impact Statement was prepared by the Department of Health and Ageing and assessed as adequate by the Office of Best Practice Regulation.
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