TGA Updates Guidance on IVD Application Audits: What Manufacturers Should Prepare For
The Australian Therapeutic Goods Administration (TGA) has updated its guidance document “Preparing for an application audit for in-vitro diagnostic medical devices”, introducing more detailed expectations for technical documentation, performance evidence, and audit readiness for IVD manufacturers.
The revised guidance, updated on 12 May 2026, reflects recent international developments, including the publication of the IMDRF Table of Contents (ToC) for IVD medical devices, and provides expanded clarification on clinical and analytical performance expectations, particularly for higher-risk and point-of-care IVDs.
Stronger Focus on Technical Documentation Quality
One of the clearest messages from the updated guidance is that the TGA expects technical documentation to be:
well-structured,
searchable,
traceable,
and submitted as a complete standalone package.
The authority explicitly states that poor document structure or inaccessible files may delay assessments and lead to requests for resubmission.
Manufacturers should also note that the TGA does not accept cross-referencing to previous applications, including devices already included in the ARTG. Each submission must independently contain all required evidence.
Alignment with IMDRF Table of Contents
The updated guidance formally acknowledges the IMDRF ToC for IVD medical devices, published in 2024, as a useful framework for preparing technical documentation.
Although use of the IMDRF ToC is not mandatory, the TGA indicates that it may help manufacturers organise submissions in a way that facilitates audit review and traceability.
For global manufacturers already preparing IVDR or other international submissions using IMDRF structures, this may support better harmonisation across regulatory markets.
Expanded Expectations for Clinical and Analytical Performance
The revised document provides significantly more detail regarding:
analytical sensitivity,
analytical specificity,
specimen equivalence,
assay cut-off validation,
software validation,
usability studies,
and stability evidence.
The TGA also reinforces expectations around:
statistically justified study design,
raw data availability,
confidence intervals,
handling of discrepant results,
and traceability to recognised reference materials.
For manufacturers of Class 3 and Class 4 IVDs, the guidance clearly raises expectations regarding the depth of evidence required during application audits.
Additional Scrutiny for Point-of-Care and Self-Test Devices
Manufacturers of point-of-care and self-testing IVDs should pay particular attention to the updated language.
The guidance now specifically requires consideration of:
intended user capabilities,
foreseeable misuse,
usability risks,
and performance validation in representative end-user environments.
The TGA also clarifies that internal procedural controls alone are insufficient for point-of-care assays and that appropriate external quality controls should be identified in the IFU.
Greater Emphasis on Post-Market Evidence
The updated guidance requests more structured post-market surveillance information, including:
complaints,
recalls,
field safety corrective actions (FSCAs),
CAPAs,
adverse events,
and jurisdictions where approval was refused.
Importantly, manufacturers are asked to clearly distinguish whether products are:
new to the Australian market, or
already commercially supplied elsewhere.
This may influence how the TGA prioritises and scopes application audits.
What This Means for Manufacturers
While the document does not introduce new legislation, it provides a clearer indication of how the TGA currently interprets audit readiness and technical evidence expectations for IVD submissions.
Manufacturers preparing ARTG inclusion applications should consider reviewing:
technical file structure,
clinical evidence reports,
risk management documentation,
stability study packages,
software validation records,
and submission formatting practices.
The guidance also suggests increasing alignment between Australian expectations and internationally recognised documentation frameworks such as IMDRF and ISO 14971.
For manufacturers already operating under IVDR requirements, several concepts will appear familiar, particularly around GSPR-style evidence mapping, lifecycle risk management, and performance evaluation expectations.
Read the full document below.
