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Legal Representation & Governance
Australian Sponsor Services & Regulatory Governance
A foreign manufacturer needs an Australian-based Sponsor to interface with the TGA and hold the ARTG inclusion. The Sponsor role is regulatory and ongoing: it requires access to technical and safety information, control of regulatory communications, vigilance readiness and the ability to act when the manufacturer changes the device or a safety issue emerges.
When This Support Is Needed
Foreign manufacturer without an Australian legal entity
Existing commercial distributor acting as Sponsor but lacking regulatory governance and independence
Transfer of ARTG inclusions from one Sponsor to another
New device launch requiring a clear manufacturer–Sponsor quality and regulatory interface
Post-market issue, recall, safety signal or overseas regulatory action affecting Australian supply
Certificate, manufacturing site, labelling or product change requiring Sponsor regulatory assessment
What We Challenge Before Submission
Manufacturer informs the Sponsor only after a change has already been implemented
Sponsor cannot access current technical or post-market records upon TGA request
Complaints reach local commercial distributors but are never escalated to the Sponsor
Overseas recall or regulator action is not assessed for Australian ARTG impact
UDI, ARTG, labelling and technical-file changes are managed in separate, disconnected silos
Our Support Includes
Pre-market Sponsor readiness and ARTG inclusion coordination
Manufacturer–Sponsor regulatory responsibilities and formal Quality/Regulatory Agreement
Access to technical, clinical, performance and safety information systems
Conditions of inclusion monitoring and compliance governance
TGA official information and sample request coordination
Complaint and adverse-event escalation protocols
Medical Device Incident Reporting (MDIR) in the TGA IRIS database
Recall / product alert / product correction support under Australian market-action procedures (PRAC)
Overseas regulatory action impact assessment
Manufacturer Evidence and ARTG change monitoring
UDI / AusUDID responsibilities and data record maintenance
Record retention and traceability compliance support
Importer and distributor communication pathways
Senior Regulatory Question:
Could the Sponsor independently demonstrate to TGA why the device remains compliant, what changed, what incidents occurred and what corrective actions were taken?
Appoint a Dedicated Australian Sponsor with Full Regulatory Integrity
Our Australian team provides independent Sponsor representation, manages TGA inquiries, and maintains post-market compliance.