The webcast will be presented in two parts. The first part will provide an overview of the current regulatory issues facing companies either supplying medical technology in Australia or intending to supply. It also will provide an update on the proposed regulatory reforms announced by the Therapeutic Goods Administration and the possible consequences of recent inquiries.
The second part of the presentation will describe how sponsors of medical technology must always cross the first hurdle of regulation to supply that technology in Australia and the unique prosthesis reimbursement scheme that presents the second hurdle of health technology assessment. Crossing the first hurdle provides no assurance of crossing the second.
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
raps@raps.org+1 301 770 2920
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