Back to Australia Overview
Section 9D Variations & Changes
ARTG Variations, Significant Changes & Device Lifecycle Support
Device changes can affect more than the technical file. A modification may affect conformity assessment evidence, Manufacturer Evidence, ARTG representation, UDI, labelling, Sponsor records or post-market obligations. Changes should therefore be assessed before implementation.
When This Support Is Needed
Design or technical specification modification to a marketed device
Raw material, chemical formulation, or critical supplier change
Software, firmware, or cybersecurity algorithmic update
Manufacturing site relocation, line extension, or legal entity transfer
Manufacturing process, sterilisation method, or cycle parameter change
Primary/secondary packaging or shelf-life / expiry date extension
Labelling, IFU, clinical indication, or intended purpose expansion
Clinical evaluation update or new performance data generation
Conformity certificate change, scope renewal, or transition to MDR/IVDR
Sponsor transfer, corporate restructuring, or manufacturer data modification
What We Challenge Before Submission
Change implemented in production before regulatory impact assessment is performed
New device model assumed to fit under existing ARTG inclusion without kind-of-device grouping review
Conformity certificate updated overseas but not reflected in TGA Manufacturer Evidence
Software update alters clinical performance or diagnostic output but is treated as routine maintenance
UDI change trigger missed during catalogue or model restructuring
Manufacturing transfer completed without validating process equivalency and regulatory evidence
Our Support Includes
Regulatory change-impact assessment against Therapeutic Goods legislation
Verification and validation requirement definition for proposed changes
Manufacturer Evidence variation strategy and TGA Business Services filing
ARTG Section 9D variation application vs. new ARTG inclusion assessment
Conformity certificate scope and notified body / CAB impact review
Technical documentation and Essential Principles update roadmap
Clinical / performance evidence impact assessment
Risk management file (ISO 14971) update and benefit-risk re-evaluation
Labelling, packaging artwork, and IFU modification review
UDI trigger analysis and AusUDID data attribute update execution
Sponsor notification protocols and governance documentation
Post-market surveillance and annual reporting continuity planning
Senior Regulatory Question:
Does the change alter the regulatory basis on which conformity was demonstrated or the kind of medical device represented in the ARTG?
Manage ARTG Variations and Device Lifecycle Changes
Our regulatory strategists assess change impact, lodge Section 9D variations, and maintain Manufacturer Evidence continuity.