TGA Issues New Fees for Devices

Starting July 1, devicemakers will pay new fees to Australia’s Therapeutics Goods Administration to register their devices and in vitro diagnostics and to keep them on the Australian Register of Therapeutic Goods.

To register devices, manufacturers and sponsors will pay roughly A$1,000 (US$747) to apply to list their devices on the ARTG.  Applicants seeking a priority review will pay A$9,840 ($7,350).

Manufacturers also will pay application audit fees that include conformity assessment application fees of A$7,030 ($5,251) and fees of A$3,080 ($2,300) to verify the application and conformity assessment.