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Medtronic Submission to Senate Inquiry into Regulatory Standards for the Approval of Medical Devices

20 September 2011

From The Parliament of Australia website:

On 16 June 2011 the Senate referred the following matter to the Senate Community Affairs Committees for inquiry and report.

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.

The committee’s inquiry will be focussing on joint replacements.

Medtronic Australia and New Zealand’s submission to this Inquiry is now available online.  You can find it by clicking here.



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