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Use Case 04 — Multi-Market Registration

Multiple markets.
One technical file.

Confideck supports registration documentation across 120+ countries and jurisdictions. Branch your technical file per market, manage only the differences, and keep every registration aligned — when entering new markets and maintaining existing ones.

RA Manager Regulatory Affairs Market Access
120+

Countries and jurisdictions supported

How it works

One core file. Branched per market.
Differences only.

01
Core technical file as the base
Your EU MDR technical file is the foundation. All common documentation — device description, risk management, clinical data — lives here once.
Core file
02
Branch per jurisdiction
For each new market — FDA, UKCA, TGA, or others — a branch is created from the core. Only the country-specific differences need to be managed.
Market branch
03
Country requirements managed separately
Each jurisdiction has its own requirements, formats, and submission rules. Confideck surfaces what's different — so teams focus only on what matters per market.
Jurisdiction-specific
04
All branches stay aligned
When the core changes, all market branches are updated automatically. Every jurisdiction stays in sync without manual re-work across files.
Aligned across markets

The outcome

What changes when every market
is always up to date.

64%
Content reused across registrations
Only the differences are managed per market. The rest is shared from the core file automatically.
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Faster preparation per new market
Branching from a structured core means preparation time drops significantly with every additional jurisdiction.
0
Out-of-sync market files
Core changes propagate to all branches automatically. Every market file stays aligned without manual coordination.