Blog title heading will go here
May 20, 2025
UDI Compliance made easy: How to handle 7 Regulatory Authorities
With regulatory requirements continually evolving, managing Unique Device
Identification (UDI) data across different international markets has become
increasingly challenging. Each regulatory authority - whether in the EU, USA,
Australia, South Korea, China, Saudi Arabia, or Taiwan - enforces its own rules,
validation checks, and submission processes. This complexity can impact medical device manufacturers, importers, distributors, and labelers working across borders.
The Challenge of Multi-Market UDI Compliance
Every country or region has distinct compliance demands:
- EUDAMED (EU): Over 200 data points per device and hundreds of validation rules.
- GUDID (USA): FDA-specific data formats and mapping.
- IMDIS (South Korea): Additional language and registration data required for submission.
- Other authorities, such as AusUDID (Australia), CUDID (China), Saudi-DI
(Saudi Arabia), and UDID (Taiwan), add further variations.
For regulatory affairs teams, manually keeping up with these differences can be resource-intensive and increases the risk of errors.
Digital Solutions for Global UDI Compliance
Several digital platforms are now designed to address these challenges. For
example, solutions like UDI Connect and UDI Hub can support compliance with up to seven regulatory authorities in a single environment:
- EUDAMED (EU)
- GUDID (USA)
- AusUDID (Australia)
- IMDIS (South Korea)
- CUDID (China)
- Saudi-DI (Saudi Arabia)
- UDID (Taiwan)
By harmonizing data and automating validation, these platforms help regulatory teams manage submissions more efficiently and consistently.
Key Features for Regulatory Affairs Teams
1. Centralized UDI Management
- Manage and harmonize UDI data for multiple authorities in one system,
reducing manual rework and the risk of inconsistencies.
2. Integration with Existing Systems
- UDI Connect is designed for teams with established IT capabilities and
can connect via API to your ERP, PLM, or other solutions, supporting
real-time data synchronization and automated workflows. - UDI Hub provides an intuitive interface for teams that prefer a browser-
based platform, requiring minimal IT involvement.
3. Automated Validation and Submission Workflows
- Automated checks against each authority’s requirements help ensure
compliance before data submission. - Examples include extensive rule validation for EUDAMED, grace period
handling for GUDID and AusUDID, and language handling for IMDIS
and CUDID.
4. Ongoing Regulatory Updates
- Platforms are regularly updated in line with evolving rules, helping
teams stay compliant as requirements change.
5. Visibility and Reporting
- Dashboards and reporting tools provide real-time oversight of
submission status, compliance metrics, and audit readiness across all
supported authorities.
How to Explore These Solutions
- Regulatory affairs teams interested in evaluating UDI Connect can access a 14 day free trial, enabling hands-on experience with automated compliance workflows and system integration.
- For those considering UDI Hub, an Early Access Program is available,
allowing teams to (soon) trial the solution and provide feedback during its rollout.
Conclusion
Global UDI compliance is complex due to each market’s unique data and validation requirements. Digital solutions that support multiple authorities, automate validation, and provide real-time integration can reduce manual effort, minimize errors, and help regulatory teams maintain compliance as regulations change.
For further details, consult the official guidance from each regulatory authority and consider digital solutions that align with your organization’s current and future compliance needs.