ADIA CEO Update: September 2024 Advocacy Update

The ADIA technical team have been actively engaged in several key projects with the TGA in the past few months. There are multiple areas where the TGA is seeking feedback from industry to ensure that the changes and developments they are making are fit-for-purpose and avoid unintended consequences.

ADIA relies on member feedback to ensure that the submissions we make cover all aspects of concern, so please join us at the next Technical Forum!

The Australian Government recently announced a significant program of reform to address the impact of artificial intelligence (AI) across multiple sectors including healthcare. The TGA have responsibility for conducting a review of the existing regulatory legislation of therapeutic goods involving AI, to identify gaps and opportunities and make recommendations for reform. Click here to read more about how the TGA regulates AI Medical Devices.

Software as a Medical Device (SaMD)

The TGA has formed a Technical Reference Group for SaMD and AI. Information about the group and its membership is available here.

Boundary products

ADIA made a submission to the TGA on Boundary Products on 6 August 2024. Most boundary products from the dental industry (toothpastes and dentifrices) can be readily categorised as Medicines or Medical Devices by the principal intended action. ADIA has recommended that the Boundary Product category for toothpastes and dentifrices is not required. Following this recent consultation, TGA is holding workshops to engage with stakeholders. If you have Boundary Products and are concerned about this consultation, please contact ADIA at advocacy@adia.org.au to discuss any issues.

Exempt Medical Devices and Other Therapeutic Goods

The TGA is proposing further changes to the regulation of Exempt Medical Devices (EMDs) and Other Therapeutic Goods (OTGs) that have significant implications for the dental industry. The proposals include potential notification, publication of information and/or provision of samples to the TGA for EMDs and OTGs. Introduction of this regulation would impose significant administrative and financial burdens on the sponsors of these types of products. On 7 June 2024, ADIA made a strong submission, arguing that for EMDs manufactured in Australia at the direction of Ahpra-registered health practitioners using raw materials that are included in the ARTG, the proposed regulations would duplicate existing frameworks and lead to significant unintended consequences, including increased costs and reduced access to EMDs for consumers. The consultation process is ongoing and ADIA will continue to advocate against these changes. This issue will be discussed in detail at the September Technical Forum.

3G network switch off

The cut-off date for Telstra and Optus to switch off their 3G networks has been extended to 28 October 2024. If you manufacture or supply medical devices or other products that communicate via 3G you need to consider the impacts on users and take steps to notify customers and mitigate any risks. See the updated webpage.

TGA Consultation | Medical Devices - Essential Principles Consultation

The TGA is consulting on proposed changes to the Australian Essential Principles for Safety and Performance of medical devices, to align with changes being implemented in the Europe (GSPR). Please follow these links for further information and the consultation paper.

Deadlines for comment: For inclusion in the ADIA submission send feedback to advocacy@adia.com.au by 5pm Wednesday 9 October 2024 or send feedback directly to the TGA by Wednesday 16 October 2024.

New and updated Information from the TGA

• Software Developers - note changes to the Essential Principle 13B Guidance
• Instructions for Use (IFU) - updated webpage