Concetta Fierravanti-Wells (NSW, Liberal Party, Minister for International Development and the Pacific) Share this | Hansard source

Currently, all applications to list devices on the prostheses list are subject to the processes outlined in the Prostheses List: Guide to listing and setting benefits for prostheses. The list advisory committee intends to review and strengthen the arrangements and processes to ensure that medical devices are assessed for comparative health outcomes that will inform private health insurance listing and benefits. The PLAC is also working cooperatively with the Therapeutic Goods Administration to look at use of post-market surveillance to inform review of device listings.

As I said, this is a two-pronged process. It is the TGA, not the PLAC, that assesses whether devices are safe to use. The TGA is informed by the independent Advisory Committee on Medical Devices, established under regulation 38 of the Therapeutic Goods Regulations 1990. The PLAC, on the other hand, assesses devices to determine what benefit levels private health insurers should be required to pay for the device. (Time expired)