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Application Audit & RFI Defense
TGA Application Audit, Regulatory Engagement & Information Requests
TGA may select an ARTG application for audit depending on the device and application pathway. Audit questions can probe far beyond administrative data and may examine the regulatory basis for classification, conformity assessment, clinical / performance evidence, Essential Principles, labelling and risk controls.
When This Support Is Needed
Application category is subject to mandatory or discretionary TGA application audit
High-risk, novel, implantable, or complex medical device / IVD submission
Using comparable overseas evidence (CE MDR, FDA) and needing to demonstrate equivalence of scope and evidence
TGA requests additional information (Section 41JA) or clarification during dossier screening
Existing submission has inconsistent evidence, outdated testing, or unclear clinical rationale
Manufacturer seeks pre-submission regulatory engagement or formal meetings on a novel technology
What We Challenge in Response Filings
Answering only the literal wording of the question without resolving the underlying regulatory concern
Providing voluminous additional documents without a clear roadmap or executive justification
Introducing new inconsistencies across the dossier while revising individual response files
Defending a classification, GMDN, or kind-of-device choice without rule-based rationale
Using overseas regulatory approval as a substitute for demonstrating direct Australian applicability
Our Support Includes
Pre-audit application readiness assessment and mock audit review
Likely audit evidence mapping and question vulnerability analysis
Technical dossier gap assessment against Essential Principles
Clinical evidence readiness and Clinical Evaluation Report (CER) defense
IVD performance evidence readiness and analytical study review
Essential Principles evidence cross-referencing and verification
Risk-management traceability and ISO 14971 consistency check
Labelling, IFU, and promotional claim harmonization
Technical justification and regulatory rationale development
Response package drafting and cross-reference control
Management of formal Requests for Information (RFI / Section 41JA)
Preparation for regulatory engagement discussions and TGA teleconferences
Senior Regulatory Question:
What regulatory conclusion is TGA unable to reach from the current dossier, and what evidence or rationale will allow that conclusion to be reached?
Defend Your ARTG Application Against TGA Audit Scrutiny
Our senior regulatory strategists deconstruct TGA queries, compile clinical justifications, and formulate rigorous response packages.