Terms of Reference

Inquiry into The Regulatory Standards for the Approval of Medical Devices

Terms of Reference

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

(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

Phone:+61 2 6277 3515
Fax:+61 2 6277 5829