New TGA guidance relating to selection criteria for medical device application audits
9 Oct 2025
AusBiotech welcomes the release of new guidance, Understanding Selection Criteria for Medical Device Application Audits, by the Therapeutic Goods Administration (TGA).
A key focus of our advocacy efforts on behalf of our medtech members, the new guidance is crucial for all medical device sponsors seeking to register a new product in Australia. The criteria used to select applications for audit focus on those that pose the highest risk to patient safety and public health.
As outlined in the guidance, the TGA conducts both mandatory (applicant pays a fee) and non-mandatory (no fee payable) audits. While the TGA can select any application for an audit, it mainly uses four risk-based criteria for non-mandatory audits:
Criteria 1: Aspects related to the application and the device
Criteria 2: Kinds of devices subject to regulatory reforms
Criteria 3: Post-market signals
Criteria 4: Factors related to the sponsor or manufacturer
For our medtech members, understanding these audit selection criteria will enable them to be better prepared, submit stronger applications, and potentially minimise regulatory timelines and costs. Read more