Inquiry into The Regulatory Standards for the Approval of Medical Devices
Information about the Inquiry
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.
Submissions should be received by 29 July 2011. The reporting date is 12 October 2011. On 08 November 2011,the Senate granted an extension of time for reporting until 22 November 2011.
The Committee is seeking written submissions from interested individuals and organisations preferably in electronic form submitted online or sent by email to community.affairs.sen@aph.gov.au as an attached Adobe PDF or MS Word format document. The email must include full postal address and contact details.
Alternatively, written submissions may be sent to:
Committee Secretary
Senate Standing Committees on Community Affairs
PO Box 6100
Parliament House
Canberra ACT 2600
Australia
Notes to help you prepare your submission are available from the website at https://www.aph.gov.au/senate/committee/wit_sub/index.htm. Alternatively, the Committee Secretariat will be able to help you with your inquiries and can be contacted on telephone +61 2 6277 3515 or facsimile +61 2 6277 5829 or by email to community.affairs.sen@aph.gov.au.
Inquiries from hearing and speech impaired people should be directed to Parliament House TTY number 02 6277 7799. Adobe also provides tools at http://access.adobe.com/ for the blind and visually impaired to access PDF documents. If you require any special arrangements to enable you to participate in the Committee's inquiry, please contact the Committee Secretariat.
Once the Committee accepts your submission, it becomes a confidential Committee document and is protected by Parliamentary Privilege. You must not release your submission without the Committee's permission. If you do, it will not be protected by Parliamentary Privilege. At some stage during the inquiry, the Committee normally makes submissions public and places them on its website. Please indicate if you want your submission to be kept confidential.
For further information, contact: Committee Secretary
Senate Standing Committees on Community Affairs
PO Box 6100
Parliament House
Canberra ACT 2600
Australia