Device regulation: what next?

Time to improve transparency and communication to the public

Quality regulation of medical devices is essential to ensure that safe and effective devices and procedures are available for use in the health care system. This not only helps protect patients, but also the companies that manufacture and sell these devices. For a variety of reasons, medical device regulation in Australia and internationally has been under increased scrutiny in recent years. In Australia, a number of reviews have been undertaken, including a review of health technology assessment,1 the Therapeutic Goods Administration (TGA) transparency review,2 and the recent Senate enquiry into the regulatory standards for the approval of medical devices in Australia.3 Each has made valuable recommendations that have the potential to enhance our current regulatory practice.