Submission to the Therapeutic Goods Administration on proposed regulatory changes to low risk assistive technologies
Audiology Australia has provided a submission to the Therapeutic Goods Administration on proposed regulatory changes to low risk assistive technologies .
Key points in AudA’s submission include:
1. The need for TGA to provide further information regarding similar assistive technology products with different risk classifications, such as hearing aid remote controls. AudA believes it would be inappropriate for similar products to be separated and regulated under two separate regulatory systems, as it will likely lead to confusion on the part of manufacturers, suppliers and health professionals, and may impose extra administrative costs.
2. AudA’s concern regarding the implications of this proposed change on assistive listening devices (ALDs) available through the Department of Health’s Hearing Services Program (HSP) – as devices offered for inclusion on the HSP must be listed on the TGA Australian Register of Therapeutic Goods (ARTG). AudA is concerned that if the change is implemented, many of these ALDs may be removed from the ARTG and, as a result, can no longer be listed on the fully-subsidised device schedule of the HSP.