Australia TGA's Guidance: Regulatory Landscape for Personalised Medical Devices and Companion Diagnostics
- Sharan Murugan
- 10 hours ago
- 3 min read
As the healthcare industry continues to evolve, the integration of personalised medical devices and companion diagnostics has become increasingly significant. In Australia, the Therapeutic Goods Administration (TGA) provides comprehensive guidelines to ensure the safety and efficacy of these medical innovations. This blog post delves into the regulatory frameworks governing custom-made medical devices (CMMDs), in vitro diagnostic (IVD) companion diagnostics (CDx), and specified articles and excluded products within the realm of personalised medical devices.
Key Points and Analysis
On 25 February 2021, a new framework for regulating personalised medical devices—including custom-made devices—came into effect in Australia. The changes significantly narrow the definition of a custom-made medical device and introduce new categories such as patient-matched and adaptable devices.
Key changes include:
Narrowed Definition: Many devices previously classified as custom-made no longer meet the definition. If you manufacture, import, or supply more than five of the same kind of device annually, it will likely need to be included in the Australian Register of Therapeutic Goods (ARTG).
Annual Reporting: Manufacturers and sponsors must report annually on custom-made devices supplied in the previous financial year.
Record Keeping: Documentation must be retained for five years (non-implantable devices) or fifteen years (implantable devices).
Recipient Information: Manufacturers must provide detailed information about each device to the intended recipient.
TGA Notification: All manufacturers and sponsors must notify the TGA about their activities, even if the device is exempt from ARTG inclusion.
Inspection Powers: The TGA can inspect production facilities and review documentation to ensure compliance.
Transition Period: For those affected by the new definitions, a transition period is in place until 1 November 2024, provided the TGA was notified before 25 August 2021.
A product is unlikely to be considered custom-made if established standards govern its design or production or if it is manufactured using consistent methods and materials.
IVD companion diagnostics are tests essential for the safe and effective use of specific medicines or biologicals. They identify patients most likely to benefit from a therapy or at risk of serious adverse reactions.
Key regulatory points:
Alignment with International Standards: Australia’s definition and requirements for IVD CDx align with those of the US FDA and the European Union.
Classification: All IVD CDx are classified as Class 3 IVD medical devices, reflecting their critical role in patient care.
ARTG Inclusion: Each IVD CDx must be individually included in the ARTG, with mandatory application audits and robust clinical evidence required.
Overseas Evidence: The TGA accepts technical assessment reports from comparable overseas regulators (EU, FDA) as part of the application process.
Concurrent Submissions: While not mandatory, concurrent evaluation of the IVD CDx and its corresponding medicine or biological is encouraged for comprehensive assessment.
In-House IVDs: Laboratory-developed (in-house) IVD CDx are also subject to regulation. From 27 May 2026, laboratories must specifically identify these in their TGA notifications and ensure compliance with accreditation standards.
The TGA guidance also clarifies which articles are specified (thus regulated) and which are excluded from the personalised medical devices framework. This distinction is crucial for manufacturers and sponsors to determine their regulatory obligations.
Key considerations:
Specified Articles: These are products that, due to their intended use or risk profile, are subject to regulation under the personalised medical devices framework.
Excluded Products: Certain products, such as those with well-established standards or low-risk profiles, may be excluded from the framework, reducing regulatory burden.
Practical Implications and Applications
For manufacturers, sponsors, and healthcare professionals, these regulatory changes have significant practical implications:
Compliance Planning: Companies must review their portfolios to determine which products now require ARTG inclusion and ensure all required notifications and documentation are up to date.
Operational Adjustments: Enhanced record-keeping, annual reporting, and recipient information provisions require updated internal processes and staff training.
Product Development: Early engagement with regulatory requirements for IVD CDx can streamline market access and support successful companion diagnostic–medicine pairings.
Laboratory Practice: In-house test developers must prepare for new notification and accreditation requirements coming into force in 2026.
Risk Management: Understanding specified and excluded products helps focus compliance resources where they are most needed.
For more detailed information, consult the original guidance documents on the TGA website for custom-made medical devices, IVD companion diagnostics, and specified/excluded products.