Global Market Access After the IVDR Transition: 100 Percent On-Time TGA Submissions
IVD diagnostics manufacturer with international distribution
Following the transition to the IVDR, a diagnostics manufacturer had to meet pressing compliance deadlines set by the Australian Therapeutic Goods Administration, with limited internal capacity and diverging requirements across multiple international markets.
The challenge
The situation
Following the transition to the In Vitro Diagnostic Regulation (IVDR), an IVD diagnostics manufacturer faced pressing compliance deadlines set by the Australian Therapeutic Goods Administration (TGA), compounded by limited internal capacity. Adding to the complexity, diverging IVDR and TGA requirements had to be navigated across multiple international markets.
Our approach
What we delivered
Reconciled Evidence-of-Product-Conformity packages with TGA requirements following the IVDR transition, including ongoing monitoring of evolving TGA guidance
Management of international registrations and renewals, including maintenance of the Eudamed database across prioritized markets
Coordination of QA, QC and Regulatory Affairs for batch release processes in line with IVDR and TGA standards
The outcome
Results & impact
100% on-time EPC submissions
Evidence-of-Product-Conformity packages delivered on schedule for all TGA submissions.
1 global registration strategy
Registration certificates secured across all prioritized target markets.
0 compliance gaps
No compliance gaps in the batch release processes.
5 prioritized markets managed
International registrations and renewals maintained across five prioritized markets.
In summary
The manufacturer achieved 100 percent on-time TGA submissions and a secured global registration strategy across five prioritized markets, with consistent compliance throughout the batch release processes.
Regulations & standards considered
- IVDR
- Therapeutic Goods Act 1989 (Australia)
Related expertise
IVD Consulting & IVDR Readiness →
Portfolio classification under Annex VIII and technical documentation under the IVDR
International Market Access →
Prioritizing target markets and registrations with the FDA, PMDA, NMPA and ANVISA
EUDAMED →
Actor registration, UDI data management and certificate linking under IVDR Art. 30
Health Authority Interaction →
Applications and variations to national authorities, plus inspection and CAPA communication
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Sources
- Entourage project experience (anonymized)
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