Big Changes in Medical Device Safety Regulations

As a testament to the volume and pace of change happening in the medical device sector, there have been several key product safety regulation developments between late 2024 and early 2025 for the Australian market. These changes primarily relate to enhanced product safety standards, increased regulation, and mandatory obligations, particularly around regulatory reporting.

International harmonisation is another theme addressed in these latest updates. The Therapeutic Goods Administration (TGA) is one of several regimes and practices in Australia are now deferring to or recognising international counterparts as part of their everyday and accepted functions.

In addition, certain popular and higher-risk product categories that are prevalent in modern day society have been targeted for regulatory change. These include more invasive medical devices and medical software.

These trends are mirrored globally. Australia’s focus on these topics ensures the country’s continued prominence as a market leader in medical device regulation. Local and international businesses alike should take an interest in these legal trends and developments.

Increased Mandatory Regulatory Reporting - Adverse Event Reporting

New mandatory adverse event reporting requirements for medical devices take effect on 22 March 2025 . The regulation follows a lengthy legislative process. In 2021, the TGA issued a public consultation to garner feedback on a discussion paper, “Potential Mandatory Reporting of medical device events by healthcare facilities in Australia.” The publication explored important topics such as the feasibility of the new obligation, the scope of its application in terms of what types of medical devices and facilities were included, potential issues with duplication, and accountability of the system as a whole.

The feedback obtained formed the basis of the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022, which was passed into law on 21 March 2023. This legislation makes it mandatory for all public and private hospitals, as well as any other healthcare facilities, to report on adverse events.

This reporting practice is aimed at greatly increasing the likely reportable events in Australia as a way to improve patient safety standards. The data collected during these reports and the post-market surveillance activities carried out thereafter will help stakeholders more quickly detect device-related issues.

In that regard, the TGA continues to collaborate with the Australian Commission on Safety and Quality in Health Care (ACSQHC) and Australian hospitals, peak bodies, and state and territory governments to improve and increase rapid information sharing about medical device safety and effectiveness.

Medical device companies should be cognisant of these new obligations within the supply chain since entities other than the device sponsor may have their own obligations to report. Stakeholders should employ a joined-up product safety approach to ensure consistency, coordination, streamlined actions, and positioning with the TGA when an obligation is triggered by one or several actors.

Traceability Requirements - Unique Device Identification

The TGA remains focused on the roll-out of its unique device identification (UDI) system, the first system of its kind in Australia. The aim is for the system to be adopted throughout the healthcare system and supply chains to allow improved tracking and tracing of medical devices. The system is positioned to assist with earlier and quicker notification to healthcare facilities, healthcare professionals, and patients if there is a medical device safety issue.

The revised regulations introduce requirements for pre-market traceability and post-market monitoring of medical devices. It will better align Australia’s regulatory framework with global standards.

To bring about the UDI system, the TGA consulted extensively with sponsors, manufacturers, and healthcare communities throughout the supply chain and collaborated with the ACSQHC. The agency also made amendments to the Therapeutic Goods Act 1989 and the Medical Device Regulations 2002, established the Australian UDI Database (AusUDID), and ran state-based healthcare pilot sites to inform use and adoption of UDI in healthcare organisations.

The TGA continues to take practical steps to fully launch the system. On 29 November 2024, the agency implemented significant enhancements to the AusUDID system, including changes where there are multiple sponsors for the same medical device consultation, database structure updates, fixes to system issues, the removal of all existing data, and updates to a bulk upload template to allow a structured way to standardize the input of large amounts of data.

On 12 December 2024, the TGA published draft guidance to help sponsors and manufacturers of medical devices comply with the newly introduced UDI obligations. Included in the guidance are the types of medical devices and in vitro diagnostic (IVD) medical devices for which the UDI regulations are applicable, labelling requirements, data submission requirements, specific device requirements, processes to get and apply a UDI, and how to submit and maintain UDI data in the AusUDID.

Medical device manufacturers should move towards early implementation of these obligations, which are aimed at improving traceability in the event of product safety issues. Lack of traceability often leads to recalls that are broader in scope. Having the ability to better identify products will be a benefit for manufacturers.

Acceptance of Global Safety Practices – FDA Approvals

On 18 October 2024, the Therapeutic Goods—Medical Devices Information Amendment Determination No. 2 2024 introduced flexibility to the Australian Register of Therapeutic Goods (ARTG) process for certain medical devices based on an expanded recognition of U.S. Food and Drug Administration (FDA) approvals. The ARTG is the public database of therapeutic goods that can be legally supplied in Australia.

In particular, Class IIa devices, which are exempt from FDA 510(k) requirements, can now utilise a Medical Device Single Audit Program (MDSAP) certificate to be included in the ARTG. Class III medical devices with clearance under FDA 510(K) can similarly make use of a MDSAP certificate for entry into the register.

However, in an attempt to continue to ensure high levels of patient safety, devices supported by 510(k) clearances must undergo a mandatory TGA application audit before being included in the ARTG. This is an additional requirement for these U.S. FDA-approved devices.

Based on this development, companies with an existing presence in the U.S. may be able to better leverage and streamline their compliance practices with careful and considered product launch planning.

Regulation of Exempt Medical Devices

The TGA is currently assessing feedback from a public consultation conducted between April and June 2024 which sought comments on proposals to improve the regulation of exempt medical devices and Other Therapeutic Goods (OTGs).

Currently, exempt medical devices and OTGs may include custom-made medical devices, patient-matched or low-volume devices, devices used only for an individual or an immediate family member, and clinical decision support software that meet specific criteria.

The main purpose of the consultation was to enhance transparency, identification, and awareness of these products, and support prompt action if safety issues arise. The results of the consultation will likely lead to regulatory changes in 2025 that are aimed primarily at enhancing transparency, identification, and awareness of exempt medical devices to improve post-market surveillance and ultimately patient safety.

These developments will complement the raft of legislative changes already in place, which the medical device industry should continue to track and implement in a timely fashion. Companies impacted by these matters should also consider early participation in consultation schemes to try and influence the appropriateness of the final legislation introduced wherever possible.

Commentary

The wide-sweeping reforms taking place in Australia reflect the growth and dynamism of Australia’s medical device industry. The developments continue to secure Australia as a world-leader in this space. Companies should consider how they can apply Australia’s increasingly stringent requirements as part of a global product portfolio.

In particular, the introduction of incident-based triggers for regulatory reporting in the context of healthcare facilities and adverse events mirrors a growing trend throughout the world. The EU in its general product safety regime and the UK in its draft general product safety regime are both moving away from the historic preference of a risk-based approach to this incident-based approach. Australia’s increased obligations in respect to incident reporting is in keeping with this global trend.

The emphasis on product traceability and identification requirements is a well-recognised and necessary precursor to successful product safety actions. Whilst potentially a large uplift at the outset, in the long run it has helped companies more accurately determine the scope of any product corrective actions and minimise the cost and possible reputational harm.

The recognition of international compliance practices is slightly against the global trend of regulatory divergence. It speaks to an international mindset that many modern-day companies are likely to appreciate.

Rapid changes around product safety issues in the medical device industry are likely to continue in Australia. Companies are encouraged to not only track but also proactively seek out these developments to ensure forward-thinking in product development matters and general compliance practices.

This article was originally published as part of the Sedgwick brand protection Australian Recall Index