TGA Updates Guidance on Selection Criteria for Medical Device Application Audits

The Therapeutic Goods Administration has updated its guidance “Understanding selection criteria for medical device application audits”, last updated on 4 August 2026.

The guidance is intended for sponsors seeking to include a medical device, including an in vitro diagnostic medical device, in the Australian Register of Therapeutic Goods.

It explains how the TGA selects medical device applications for audit and helps sponsors prepare and respond to information requests where an application is likely to be selected.

Purpose of the Guidance

The guidance applies to applications for inclusion in the ARTG only. It does not apply to Device Change Requests or variations.

The TGA explains that application audits are intended to verify that devices comply with Australian regulatory requirements before they are included in the ARTG.

The audit selection criteria apply to all new medical device applications, regardless of classification.

Risk-Based Application Audit Framework

The TGA states that it may select any application for audit for any reason, but generally uses four main risk-based criteria to guide audit selection.

These criteria are:

• aspects related to the application and the device;

• kinds of devices subject to regulatory reforms;

• post-market signals;

• factors related to the sponsor or manufacturer.

This risk-based approach is intended to focus regulatory efforts proportionate to risk, while reducing unnecessary regulatory burden and supporting timely access to safe devices.

Mandatory Application Audits

The guidance explains that Regulation 5.3 of the Therapeutic Goods Regulations requires the TGA to always select some types of applications for audit.

Following amendments in 2024, mandatory audits are limited to certain higher-risk applications.

These include, among others, certain Class III medical device applications supported by EU MDD certificates, UK approved body certificates or US 510(k) approval, as well as certain system or procedure pack applications and higher-risk IVD applications supported by specified evidence pathways.

Non-Mandatory Audit Selection Criteria

Any application for a medical device, including an IVD, may be selected for a non-mandatory audit.

The TGA explains that selection is based on published audit selection criteria and information available in the application, as well as TGA records and systems.

Non-mandatory audits may be triggered where clarification is needed, where regulatory history raises concerns, where certain overseas regulatory pathways are used, or where the device type falls within areas affected by regulatory reforms.

Regulatory Reforms, UDI and AI

The guidance identifies several device types and topics linked to regulatory reforms that may result in audit selection.

These include:

• IVD companion diagnostics;

• medical device software classification;

• software and artificial intelligence;

• patient implant cards and patient information leaflets;

• medical devices incorporating medicinal substances;

• vaping medical devices;

• devices using button batteries;

• mercury-containing devices;

• substances introduced into the body or absorbed by the skin;

• UDI requirements for applications supported by comparable overseas regulator approvals.

The guidance notes that higher-risk device applications incorporating AI technologies, such as machine learning or large language models, may be selected for audit, with the assessment focusing on how AI contributes to the device’s intended purpose.

Post-Market Signals

The TGA also considers post-market signals when selecting applications for audit.

Applications may be selected where devices are the subject of significant recent or ongoing post-market reviews, or where other post-market signals identify substantial patient risks, increased trends in known harms or emerging harms.

The guidance lists device categories that have previously been subject to post-market review and may be selected for non-mandatory audit, including breast implants, foetal dopplers, airway clearance devices, hyperbaric chambers, surgical mesh, spinal cord stimulators, ventilators and other device types.

Impact on Medical Device and IVD Sponsors

For medical device and IVD sponsors seeking ARTG inclusion, the updated guidance reinforces the importance of preparing a complete, well-supported application.

Sponsors should pay particular attention to:

• preliminary assessment requirements;

• mandatory audit triggers;

• non-mandatory audit selection criteria;

• evidence supporting the intended purpose;

• alignment with comparable overseas regulator approvals;

• regulatory history of the device, sponsor and manufacturer;

• UDI allocation and labelling evidence;

• AI and software validation information;

• post-market signals and previous reviews;

• clear cover letters and supporting documentation.

For sponsors, the guidance highlights the value of proactively addressing known audit selection criteria within the application to support efficient assessment and reduce avoidable delays.