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
Comprehensive management of international registrations and renewals, including maintenance of the Eudamed database across prioritised 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 prioritised target markets.
0 compliance gaps
No compliance gaps in the batch release processes.
5 prioritised markets managed
International registrations and renewals maintained across five prioritised markets.
In summary
The manufacturer achieved 100 percent on-time TGA submissions and a secured global registration strategy across five prioritised markets, with consistent compliance throughout the batch release processes.
Regulations & standards considered
- IVDR
- TGA (Therapeutic Goods Administration)
Related expertise
IVDR Readiness →
The project centred on reconciling Evidence-of-Product-Conformity packages with TGA requirements after the IVDR transition, exactly the kind of post-IVDR compliance work this expertise area covers.
International Market Access →
The manufacturer needed a single global registration strategy spanning five prioritised international markets with diverging IVDR and TGA requirements.
EUDAMED →
Maintaining the Eudamed database across prioritised markets was an explicit part of the international registration management delivered in this project.
Health Authority Interaction →
Ongoing monitoring of evolving TGA guidance and coordinating submissions with the Australian Therapeutic Goods Administration required continuous, direct interaction with the health authority.
Similar projects
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Sources
- Entourage project experience (anonymised)
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