Australian in vitro diagnostic companies wanting to market their products under the newly enacted IVD legislative framework will have to pay an initial fee of Aus$790 (US $720) to register their products with the Therapeutic Goods Administration1,2.
The agency, during initial discussions with industry associations about the IVD framework, had agreed that the product registration fee would be $300; it has since decided, however, to align its IVD pricing schedule with that of other medical devices, as the work load involved in processing both types of applications is the same3...
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