Understanding the TGA’s Proposed Changes to IVD Classification – What Could This Mean for Manufacturers?

In May 2025, the Therapeutic Goods Administration (TGA) outlined proposed changes to the way in vitro diagnostic (IVD) medical devices are classified in Australia.

The proposal was introduced by the TGA in an online presentation and accompanying materials, outlining a plan to bring Australia’s IVD classification framework more closely in line with the European Union’s In Vitro Diagnostic Regulation (IVDR). This reflects the TGA’s broader goal of achieving greater global alignment and ensuring that IVDs are regulated in proportion to their level of risk.

While these proposals are not yet in effect, they represent a significant indication of the TGA’s future regulatory direction. For manufacturers, these potential changes may not only affect how IVDs are classified but could also have broader implications for post-market monitoring, particularly the way feedback from the field is collected and analysed.

Potential Impact on Market Feedback and Post-Market Surveillance

A key consideration for manufacturers is how future regulatory developments could interact with post-market vigilance systems.

If new requirements eventually affect how health professionals report device issues or adverse events – for example, if mandatory reporting to the TGA becomes more common – it may alter the flow of information manufacturers receive directly from the market.

This could lead to:

• A reduction in the volume of direct feedback provided by health professionals to manufacturers or sponsors.
• Less detailed information available to manufacturers for early signal detection and trend analysis.
• The need for manufacturers to strengthen proactive monitoring systems to ensure they continue receiving sufficient post-market intelligence.

Even though the current proposal focuses on classification rules and definitions, it forms part of a wider movement by the TGA to improve regulatory clarity and post-market performance monitoring across all medical devices. Maintaining strong feedback channels with users will remain a cornerstone of compliance and device safety.

Considerations for Manufacturers

Manufacturers may wish to take a strategic view of how potential classification or regulatory updates could impact the practical management of feedback and vigilance. Some useful actions to consider include:

1. Review Feedback Collection Processes

• Evaluate how information from health professionals, distributors, and users currently reaches your organisation.
• Identify whether existing systems would remain effective if reporting behaviours in the market were to shift.

2. Enhance Active Monitoring Mechanisms

• Strengthen Post-Market Surveillance (PMS) programs to include proactive data collection, such as user surveys or follow-up programs.
• Use internal data (e.g. complaint logs, service records, performance reports) to supplement external feedback.

3. Maintain Clear Communication Channels

• Reinforce to customers and healthcare professionals that feedback to the manufacturer remains essential for continuous improvement and regulatory compliance.
• Update Instructions For Use (IFUs) or service documentation, where appropriate, to include clear directions for reporting feedback directly to the manufacturer or sponsor.

4. Assess Risk Management and PMS Documentation

• Review your risk management and PMS procedures (ISO 14971, ISO 13485) to confirm that methods for capturing and acting on feedback are well defined and traceable.
• Ensure responsibilities for feedback review and escalation are clear within your Quality Management System (QMS).

5. Prepare for Evolving Regulatory Alignment

• Monitor TGA communications for future developments and implementation timelines.
• If your company also supplies devices to Europe, assess opportunities to align Australian PMS processes with IVDR post-market expectations for consistency and efficiency.

Key Takeaways

Although the TGA’s proposed IVD classification changes have not yet been adopted, they highlight the regulator’s intent to refine and strengthen the framework governing diagnostic devices in Australia.

For manufacturers, the potential knock-on effects on market feedback and post-market monitoring deserve careful attention.

Proactive vigilance, clear user communication, and strong internal monitoring systems will help ensure that critical market information continues to reach manufacturers – supporting both regulatory compliance and the ongoing safety and performance of IVDs in use.

How KD&A Can Support

If your organisation would like support in evaluating how potential regulatory changes may affect your PMS or feedback systems, please contact our team to discuss tailored solutions.