Potential changes to the Therapeutic Goods Determination 2018

The Therapeutic Goods Administration (TGA) is currently seeking feedback on options for amending the Therapeutic Goods (Excluded Goods) Determination 2018 (the Determination) and whether certain low-risk assistive technology products, including ones relevant to hearing should continue to be regulated by the TGA or reclassified as consumer goods.

Products could be reclassified as consumer goods in circumstances where the product poses little or no risk to consumers, should it not perform as specified or malfunction, or may be best regulated under Australian consumer law only. If a product is identified as an “excluded product” in the Determination, it is considered to be a consumer good and therefore regulated by the ACCC rather than as a therapeutic good by the TGA.

The TGA is seeking stakeholder feedback on whether the following hearing products should either be (a) excluded from the TGA jurisdiction and regulated under consumer law, (b) excluded when used, advertised or presented in a particular way or (3) regulated as a “medical device” and therapeutic good by the TGA: