TGA Updates Guidance on Medical Device Application Audit Selection Criteria
The Therapeutic Goods Administration (TGA) has updated its guidance “Understanding selection criteria for medical device application audits”, intended for sponsors seeking to include a medical device, including an in vitro diagnostic medical device, in the Australian Register of Therapeutic Goods (ARTG).
The guidance explains how the TGA selects medical device applications for audit and aims to help sponsors prepare and respond to requests for information when an application is likely to be selected.
According to the document, the audit selection criteria apply to all new medical device applications, regardless of classification. The guidance applies to applications for inclusion in the ARTG only and does not apply to Device Change Requests (DCRs) or variations.
Risk-Based Audit Selection
The TGA states that application audits are intended to verify that devices comply with Australian regulatory requirements before they are included in the ARTG.
The guidance identifies four main risk-based criteria used to support audit selection:
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.
The TGA also notes that any application, including an IVD medical device application, may be selected for a non-mandatory audit based on the published selection criteria.
Key Areas Covered
The guidance addresses several areas that may lead to audit selection, including:
differences between the application and comparable overseas regulator approvals;
concerns about device classification or intended purpose;
IVD companion diagnostics;
medical device software and artificial intelligence;
patient implant cards and patient information leaflets;
devices incorporating medicinal substances;
UDI requirements;
post-market signals;
sponsor or manufacturer compliance history.
The updated guidance also includes information on Unique Device Identification (UDI). The TGA states that UDI requirements apply to medical devices supplied in Australia, with phased compliance beginning according to device risk classification.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers seeking access to the Australian market, the guidance highlights the importance of submitting complete, clearly labelled and well-supported ARTG applications.
Manufacturers and sponsors should pay particular attention to the evidence supporting the device’s intended purpose, classification, technical documentation, UDI information and any differences between the Australian application and overseas approvals.
For IVD manufacturers, the guidance is particularly relevant because it covers IVD applications, including companion diagnostics, Class 3 and Class 4 IVDs, point-of-care IVDs and self-test IVDs.
The guidance also reinforces that sponsor or manufacturer compliance history may influence whether future applications are selected for audit.
