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Clinical Registers for High Risk Implantable Medical Devices – Regulation Impact Statement – Department of Health and Ageing

On 13 September 2012, the Government response to the Senate Inquiry report on the regulatory standards for the approval of medical devices in Australia was tabled in the Senate. The Government has agreed in-principle to the development of clinical registers for high risk implantable medical devices. Patients with a high risk implantable medical device that may represent a health risk can be difficult to identify and notify. Development of clinical registers for high risk implantable medical devices could potentially reduce risks to patients’ safety, and costs to patients, industry, health service providers, government and other funders, due to poorly performing devices. A period of investigation is proposed to enable further consultation on the models, scope, governance arrangements and funding mechanisms for registers of high risk medical devices. A Regulation Impact Statement (RIS) was prepared by the Department of Health and Ageing. The RIS was assessed as adequate by the Office of Best Practice Regulation.