The regulatory standards for the approval of medical devices in Australia, with
particular attention to devices with high revision rates, and in undertaking the inquiry
the committee consider:
(a) the role of the Therapeutic Goods Administration in regulating the quality of
devices available in Australia;
(b) the cost effectiveness of subsidised devices;
(c) the effectiveness and accuracy of the billing code and prostheses list;
(d) the processes in place to ensure that approved products continue to meet Australian standards;
(e) the safety standards and approval processes for devices that are remanufactured
for multiple use;
(f) the processes in place to notify the relevant authorities and the general public of
high revision rates or possible faulty devices;
(g) the effectiveness of the current regimes in place to ensure prostheses with high
revision rates are identified and the action taken once these devices are
identified;
(h) the effectiveness of the implemented recommendations of the Health
Technology Assessment; and
(i) any other related matter.
For further information, contact: Committee Secretary
Senate Standing Committees on Community Affairs
PO Box 6100
Parliament House
Canberra ACT 2600
Australia