Medical device reforms: Consumer Working Group meeting statement, Meeting 16, 25 March 2025

Agenda and discussion highlights

The Medical Devices Consumer Working Group (MDCWG) met on 25 March 2025 to discuss key updates and provide consumer input on a range of regulatory matters. Topics covered included:

• The Australian Unique Device Identification (UDI) database and mandatory medical device adverse event reporting requirements for hospitals.
• Airport security screening procedures for travellers with medical devices.
• Access to nicotine vaping products for smoking cessation and medicinal cannabis vaping devices.
• The Government’s forward work plan on the safe use of Artificial Intelligence (AI) in healthcare.
• Proposed changes to the regulation of exempt medical devices and Other Therapeutic Goods (OTGs)
• Progress on the MDCWG 2024 workplan.

Key updates and outcomes

Unique Device Identification (UDI) system and mandatory adverse events reporting

The TGA provided an update on recent legislative changes approved the Government to commence the UDI system in Australia and the start of mandatory reporting of medical device adverse events by all hospitals. Key points included:

• The primary aim of the UDI system is to enhance the traceability of medical devices, by requiring manufacturers provide unique identifiers on all implantable medical devices and to also place the unique identifier on all the labelling and packaging. This will support improved safety, transparency, and post-market surveillance.
• New mandatory reporting requirements have been introduced for public, private and day hospitals to provide medical device adverse events to the TGA. This aims to strengthen oversight of device safety, ensuring timely detection and faster action and management of emerging issues.
• Transition periods have been introduced for both new initiatives to help hospitals and medical device manufacturers implement systems to comply with the new requirements.

Airport security screening

Representatives from the Dept of Home Affairs joined the meeting to updated members on ongoing discussions and activities occurring including with the Australian Airports Association to address issues and improve airport screening procedures for people travelling with medical devices.

Vaping devices: smoking cessation and medicinal cannabis

The TGA presented on the regulatory pathways for nicotine vapes used in smoking cessation and for medicinal cannabis vaping devices. Members:

• Noted the regulatory differences and separate access pathways for each product type.
• Provided feedback on how this information is presented on the TGA website, with suggestions to improve accessibility for consumers.

Artificial Intelligence in healthcare

The TGA summarised outcomes from its legislative review and stakeholder consultation on the use of AI in healthcare. It also presented its forward work plan to address the issues raised, including undertaking a more detailed review of the current exemptions and exclusions. Discussion points included:

• Consumer concerns regarding transparency in data sharing and the use of AI in clinical settings.
• The need for broad public education to improve understanding of AI technologies in healthcare.

Regulation of exempt medical devices and OTGs

The TGA outlined proposed changes following recent sector-specific workshops. Member feedback was sought, with members:

• Expressing support for the proposals, and
• Highlighting the importance of increased transparency in the supply and use of exempt devices.

Next meeting

The next MDCWG meeting is proposed for July 2025.