ATSA has renewed calls for the assistive technology (AT) industry to respond to Therapeutic Goods Australia’s (TGA) proposed fees and charges for 2019-20 which are reviewed annually in consultation with stakeholders.
ATSA executive officer, David Sinclair, is urging ATSA members to take the opportunity to shape what form these responses will take. Sinclair said that no acknowledgement will signal to the TGA that the AT sector is not concerned with TGA charges. “I strongly encourage a response, either directly to the TGA or via ATSA,” he said.
TGA is seeking feedback on the potential impact of the proposed options, prior to seeking approval from Health Minister Greg Hunt. Subject to ministerial approval, it is expected that the amendment regulation to give effect to the new fees and charges would be submitted for consideration by the Federal Executive Committee before the next Federal Budget. This will allow sufficient notice to sponsors about changes to fees and charges effective from July 1, 2019.
Industry representative groups, including ATSA, were consulted on the proposed changes to fees and charges last December.
ATSA also commented that with the changing landscape of the supply of AT, an app or piece of software may need to register under the Australian Register of Therapeutic Goods. For details of the TGA proposal go to: http://www.tga.gov.au/consultation/consultation-fees-and-charges-proposal-2019-20
For an overview go to: https://www.tga.gov.au/regulation-software-medical-device
Public consultations to the TGA close on February 8, 2019 and via ATSA on January 28, 2019.