The Australian Therapeutic Goods Administration (TGA) updated its official guidance, Understanding selection criteria for medical device application audits, on 4 August 2026. This latest revision specifically updates Criterion 3: Post-market signals, expanding pre-market oversight to active post-market review focus areas – most notably incorporating a direct link and heightened scrutiny for curettes used in gynaecological procedures.
1. Highlight of the August 2026 Update: Focus on Gynaecological Curettes
Under the updated Criterion 3 (Post-market signals), the TGA directly links pre-market audit selection to ongoing post-market surveillance. The 4 August 2026 revision explicitly highlights gynaecological curettes, signaling that new inclusion applications for these instruments will face an increased likelihood of being selected for non-mandatory application audits.
When post-market signals, adverse event trends, or active safety reviews identify substantial risks associated with specific medical devices, the TGA incorporates these insights straight into its audit selection framework. Consequently, sponsors submitting new ARTG applications for gynaecological curettes should prepare for deeper regulatory evaluation prior to market authorization.
2. Mandatory Application Audits: Detailed Eligibility Conditions
While post-market signals drive non-mandatory selections, certain high-risk applications are legally required to undergo a Mandatory Application Audit under Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002. These audits incur a mandatory assessment fee and apply under the following specific conditions:
- Class III Medical Devices with Specific Pathways: Class III applications that rely on European Union MDD certificates, UK Approved Body certificates, or US FDA 510(k) pre-market notifications.
- System or Procedure Packs (SOPPs): SOPP applications (under Schedule 3 Clause 7.5) containing at least one component that is a Class III device supported by EU MDD, UK, or US 510(k) approvals, or any Class 3, Class 4, Point-of-Care (PoC), Self-test, or Class 4 In-house IVD.
- High-Risk & Special-Use IVDs Without COR Approval: Applications for Class 4 IVDs, Class 3 IVDs, PoC IVDs, or Self-test IVDs that rely on EU IVDD, UK certificates, ISO 13485, or MDSAP certificates without a supporting Comparable Overseas Regulator (COR) assessment report.
✎ Technical File Requirement: For mandatory audits (especially IVDs), sponsors must submit a complete technical file, including analytical and clinical performance studies, stability data, and usability evaluations for self-tests.
3. Non-Mandatory Audits & Practical RA Takeaways
Applications not subject to mandatory audits may still be selected for a Non-Mandatory Audit (currently free of audit fees) based on four risk criteria:
- 1) Criterion 1: The application and device details (e.g., regulatory history).
- 2) Criterion 2: Regulatory reforms (e.g., software/AI, patient implant cards).
- 3) Criterion 3: Post-market signals (updated 4 August 2026 for gynaecological curettes).
- 4) Criterion 4: Sponsor or manufacturer compliance history.
Key Recommendation for Sponsors: To avoid processing delays, sponsors submitting applications under active post-market focus—such as gynaecological curettes—should attach comprehensive Cover Letters, clear Instructions for Use (IFU), and labeling upfront during initial submission.
Understanding a new market often requires both local knowledge and regional experience. With our local offices in Australia & New Zealand and 26+ years of experience across Asia Pacific, Qualtech supports medical device companies in navigating market regulatory requirements and evaluating growth opportunities. Contact us to discuss your plans for the ANZ region.
Reference
Understanding selection criteria for medical device application audits