Australian in vitro diagnostic companies wanting to market their products under the newly-enacted IVD framework will have to pay a fee of Aus$790 (US $720) to register their products with the Therapeutic Goods Administration1,2.
The agency had previously said that the product registration fee would be Aus$300, but has since decided to align its IVD pricing schedule with that of medical devices, as the work involved in processing both types of application is the same3...
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