April 23, 2026

From Voluntary to Mandatory: The Evolution of Post-Market Surveillance in Australia

Over the past 12–18 months, Australia has undergone a significant transformation in how Post-Market Surveillance (PMS) for medical devices is structured and regulated. What was once largely a sponsor-driven system is evolving into a more integrated, multi-source framework.

Understanding this shift is critical for sponsors and manufacturers operating in Australia, particularly as regulatory expectations continue to increase.

A System in Transition

Three key developments are driving this evolution:

1. PRAC Reforms (March 2025)

The introduction of the Procedure for Recalls, Product Alerts and Product Corrections (PRAC) marked the first major step in modernising PMS in Australia.

PRAC replaced the previous Uniform Recall Procedure for Therapeutic Goods (URPTG) framework and introduced:

  • Simplified recall categories
  • Streamlined reporting processes
  • Improved communication with the Therapeutic Goods Administration (TGA)
  • Enhanced systems and templates

This change signalled a move toward a more structured and transparent approach to market actions.

2. Mandatory Reporting by Healthcare Facilities (March 2026)

As of 21 March 2026, healthcare facilities are now required to report certain adverse events directly to the TGA.

This represents a fundamental shift in the PMS model:

  • Sponsors are no longer the sole source of vigilance reporting
  • The TGA now receives parallel data streams from both sponsors and healthcare providers

While this strengthens patient safety outcomes, it also introduces new complexity for sponsors who may not have visibility of all reported events.

3. UDI Implementation (Commencing July 2026)

The rollout of the Unique Device Identification (UDI) system will further enhance PMS by enabling:

  • Improved traceability of devices across the supply chain
  • Faster identification of affected products during recalls
  • Greater integration with healthcare systems and patient records

UDI is expected to play a critical role in linking device data, adverse events, and regulatory actions.

What This Means in Practice

Taken together, these developments indicate a clear direction:

Australia is transitioning toward a fully integrated, data-driven post-market surveillance ecosystem.

This evolving system will be characterised by:

  • Multiple reporting sources
  • Increased regulatory visibility
  • Enhanced traceability
  • Faster identification of safety signals

Emerging Challenges for Sponsors

While these changes improve overall system robustness, they also introduce new challenges for sponsors:

  • Reduced visibility of adverse events reported directly by healthcare facilities
  • Increased expectations for proactive signal detection
  • Greater complexity in maintaining aligned and complete PMS data
  • Heightened scrutiny during audits and regulatory inspections

Sponsors are now expected to demonstrate that their PMS systems remain effective even where data inputs are not entirely within their control.

Practical Steps for Industry

To remain compliant and well-positioned under this evolving framework, sponsors should:

  • Review and update PMS procedures to align with PRAC and mandatory reporting requirements
  • Assess readiness for UDI implementation, including data and labelling considerations
  • Strengthen signal detection methodologies beyond complaint handling
  • Ensure clear roles and responsibilities across sponsors, manufacturers, and distributors

Looking Ahead

These changes are not isolated updates, but part of a broader regulatory shift toward a more proactive and connected surveillance system.

Sponsors who take steps now to adapt their PMS systems will be better positioned to:

  • Maintain compliance
  • Reduce regulatory risk
  • Demonstrate robust systems during audits

How KD&A Can Support

KD&A is currently supporting clients with:

  • PMS system reviews and updates
  • PRAC alignment
  • UDI readiness and implementation
  • Regulatory strategy and audit preparation

If you would like to discuss how these changes may impact your organisation, please feel free to get in touch.

Get in touch the KD&A Team