Therapeutic Goods Administration (TGA) is a regulatory body, part of the Australian Government Department of Health, that is responsible for regulating prescription medicine, vaccines, vitamins & minerals, medical devices, blood and blood products. TGA’s role is to ensure risk-based approach to regulation of therapeutic goods in a safe and sustainable Australian market. TGA also deals with advertisement and regulation of products under the TGA in the Australian Market.
On 25th October 2019, TGA has invited the community, and Audiology stakeholders to comment or participate in the regulation of hearing aids, hearing aid remote control, hearing aid enhanced audio attachment, and hearing aid neck induction loop. In their consultation paper published, TGA invites as follows;
“We seek your views on the proposed options for amending Schedule 1, Item 9 and, if required, Schedule 2 of the Determination. Your input will assist us to address any unintended consequences and inform the proposal and implementation of a clearer Determination.”
The potential for exclusion of hearing aids from TGA will result in the products being cateogrised as consumer goods and will be regulated under Australian Competition & Consumer Commission (ACCC).
More information is available in the TGA’s consultation paper available here: https://www.tga.gov.au/consultation/consultation-products-used-and-people-disabilities
How Would this Change Impact Clients
The potential changes, if the medical devices are excluded, would result in a restructure in pricing for the products, and reduce barriers to entry for hearing aid supplies as regulated under TGA. Essentially any hearing aid product could then enter the market without requiring TGA approval. Some clients, who benefit from TGA disability criteria, may also not be eligible for discounts or free hearing aids following an exclusionary change.
However, the full scope of changes & potential impact on clients can only be speculated on at this stage. The TGA committee is set to announce their resolution late in 2019. For more information, visit the TGA website or contact Art of Hearing on (08) 9390 8811.