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Application Audits

Overview​

Application audits are the TGA's mechanism for verifying that medical devices comply with Australian regulatory requirements before they are included in the ARTG. The TGA can select any application for audit. In 2024, Regulation 5.3 was amended to limit mandatory audits to specific higher-risk application types, while the TGA retains discretion to select any application for a non-mandatory (risk-based) audit. Understanding which applications are subject to mandatory audit — and how to prepare — is essential for managing ARTG applications efficiently.

Mandatory Audit — Current Criteria (from 2024)​

The following application types are currently subject to mandatory audit:

General medical devices:

  • Class III applications supported by EU Medical Devices Directive (MDD) certificates
  • Class III applications supported by US 510(k) pre-market notification
  • System or Procedure Pack (SOPP) applications with a DoC under Schedule 3, Clause 7.5 where components include any of the above

IVD medical devices:

  • Class 4 IVD applications
  • Class 3 IVD applications (most cases)
  • Point-of-care IVD applications
  • Self-test IVD applications
  • Class 4 in-house IVD applications
  • The above when supported by MDSAP certificates without a comparable overseas regulator product approval

Applications that would previously have been subject to mandatory audit but that are now supported by EU MDR certificates or other current comparable overseas regulator evidence may no longer be subject to mandatory audit — check the current TGA guidance.

👉 Application audit selection criteria — TGA

Risk-Based (Non-Mandatory) Audit Selection​

The TGA uses four main risk-based criteria to select additional applications for audit:

  1. Device risk — higher-risk devices or novel technologies
  2. Evidence quality — applications where evidence does not clearly support the device type or classification
  3. Sponsor/manufacturer history — past compliance history of the sponsor or manufacturer
  4. Emerging safety signals — device types where post-market signals suggest pre-market review is warranted

No audit fee applies to non-mandatory audits.

How an Audit Works​

Step 1 — Notification The TGA notifies the sponsor that their application has been selected for audit and issues a request for information (RFI). The RFI specifies the documents required and the timeframe for response (typically a number of weeks).

Step 2 — Response The sponsor provides the requested documents, obtained from the manufacturer where necessary. Delays in obtaining information from the manufacturer are a common cause of audit delays — the written sponsor-manufacturer agreement should address this.

Step 3 — TGA assessment The TGA reviews the documents against the Essential Principles and applicable conformity assessment requirements. The TGA may issue follow-up questions or requests for additional information.

Step 4 — Outcome If the audit is satisfactory, the application proceeds to inclusion. If the TGA identifies deficiencies, it may reject the application or seek further information.

How to Prepare​

To reduce the likelihood of audit delays:

  • Submit a comprehensive cover letter explaining the application, any relevant context, and identifying any related devices or ARTG entries
  • Submit key supporting documents proactively with the application, even if not formally requested — IFUs, technical summaries, and clinical evaluation reports help the TGA assess the application more efficiently
  • Ensure manufacturer evidence scope matches — the QMS and product certificates must explicitly cover the device type and intended purpose in the application
  • Check document currency — all certificates and standards references must be current at the time of application
  • Have technical documentation ready — the manufacturer must be able to provide technical file documents within the required timeframe if requested

Official Sources​