An Action Plan for Medical Devices was released in April 2019 and included a three-part strategy to strengthen Australia's regulatory system, whilst continuing to be patient focused and have greater transparency and increase public confidence in Australia's medical device regulatory system.
Over the past 5 years there have been several medical device reforms undertaken to Improve Australia’s medical device regulatory framework as outlined in the Action Plan. Previous progress reports outline activities undertaken each year to strengthen the regulation of medical devices in Australia.
In summary, we have:
- Conducted over 70 public consultations to gather stakeholder input and refine regulatory processes.
- Published over 160 pieces of guidance, including updates and fact sheets, to support the implementation of new regulations and provide clarity to stakeholders.
- Made continuous efforts to align Australian regulations with international standards, particularly the EU MDR/IVDR and IMDRF.
- Delivered over 375 presentations at conferences and forums, over 100 workshops and 80 webinars, to engage with industry, healthcare professionals, and other stakeholders.
- Made several updates to legislation and regulations to improve the market entry process for new medical devices.
- Established and maintained working groups with state and territory health departments and the Australian Commission on Safety and Quality in Health Care.
- Enhanced post-market adverse event reporting and surveillance, including introducing mandatory reporting by healthcare facilities.
- Piloted the Medical Device Vigilance Program to improve compliance and awareness among sponsors.
- Developed and launched the Australian Unique Device Identification scheme to improve tracking of medical devices.
- Engaged consumer advocacy groups, support groups, and industry to gather feedback and improve transparency for medical devices in Australia.
- Published updated guidance on Patient Information Leaflets (PILs) and Patient Information Cards (PICs) based on consumer feedback.
- Established and maintained multiple working groups, including the Medical Device Consumer Working Group, Breast Implant Expert Working Group, and Women's Health Product Working Group.
- Developed and published fact sheets and other materials to provide clear and accessible information to patients.
- Conducted campaigns to inform consumers about important topics, such as traveling with medical devices.
In 2024 we continued work to improve to strengthen Australia’s medical device regulatory framework
Strategy 1: Improve how new devices get on to the market in Australia
In 2024 we released 11 public consultations which included consultations on Clinical Decision Support System Software, Boundary and combination products, Essential Principles and Instructions for Use. Consultation papers and outcomes can be found on the TGA Consultation hub.
In 2024, we implemented new requirements for clinical trials, updated the In-house IVD notification forms, expanded transitional arrangements for software based medical devices, and introduced new pathways for applications that require TGA review.
We held over 50 workshops and webinars on a range of topics such as Artificial Intelligence, software transitions, exempt medical devices of boundary products, and instructions for use.
We continued to support industry, healthcare professionals and other stakeholders manage the impacts of the transitions in the European Union from the previous medical device Directives to the new medical device Regulations, including in vitro diagnostics. Regulatory changes are in place to align with the EU changes and extend the transition deadline of the reclassification of certain medical devices to 1 July 2029.
Over 41 pieces of guidance were published to support the implementation of new or refined regulations and provide clarity to stakeholders, including:
- Real World Evidence
- Companion Diagnostics
- Boundary and combination products
- Excluded software
Strategy 2: Strengthen monitoring and follow up of devices already in use
Following the 2023 legislative amendment to require all Australian public, private, and day hospitals to report medical device adverse events, we have continued to work closely with all jurisdictions and the private hospital sector on the implementation through a Steering Committee and a Technical Working Group.
In 2024, we completed five post-market reviews:
- Spinal cord stimulation (SCS) devices
- HIV nucleic acid tests (NATs)
- Energy based devices used for vaginal rejuvenation
- Influenza A NATs
- Neonatal incubators
The Medical Device Vigilance Program concluded its 12-month pilot program, which aimed to improve sponsor awareness of their legislative responsibilities and verify compliance with regulatory reporting, information holding and recording requirements. An evaluation is underway to inform a future vigilance program.
The Australian Unique Device Identification (UDI) system is a major reform that will strengthen patient safety by improving the tracking of medical devices. The supporting regulations will commence from March 2025, alongside supporting guidance documentation. The database will include the ability for sponsors to submit electronic Patient Information Leaflets and electronic Instructions for Use to the database.
We continue to meet with state and territory health jurisdictions to monitor and manage potential medical device supply disruptions.
Strategy 3: Provide more information to patients about the devices they use
In 2024, our expert working groups met regularly over the year. We also established a new Technical Reference Group for Software as a Medical Device and Artificial Intelligence comprised of specialist technical and expert help with complex issues relating to software and AI technologies which may impact medical device regulation. The group held two meetings in 2024.
The Medical Devices Consumer Working Group (MDCWG) held three meetings in 2024 and provided advice on reforms including software and AI regulations. The MDCWG also provided input into consumer-focused campaigns and content such as adverse event reporting and travelling with medicines and medical devices.
The Women's Health Products Working Group (WHPWG) held three meetings in 2024 and provided advice on a range of topics including:
- The regulation of software and AI
- Health equity considerations in medical device regulation
- Gender equity in medical research
- Specific medical device issues that impact women.
The Breast Implant Expert Working Group (BI-EWG) concluded in April 2024 and finalised a number of documents to support the regulation and information about breast Implants such as, updated standards, TGA’s clinical evidence guidelines’ and TGA’s risk framework.
Summary and next steps
This will be the final progress report card in relation to An Action Plan for Medical Devices.
COVID-19 and the extended timelines for the EU medical device Regulations transition has impacted the progress on some of the reforms, such as the review on conformity assessment procedures, Essential Principles and In Vitro Diagnostics (IVDs). These reforms are in progress, with changes and implementation to be informed by feedback and continued engagement with stakeholders. Progress will be shared through website updates and stakeholder communications. We will also be undertaking regular reviews of implemented reforms to ensure that they have delivered expected benefits, remain current and fit-for-purpose, and to apply refinements where required.