UDI Data Submission Service | GHX

UDI Data Submission Service

The GHX UDI Data Submission service, in partnership with PTC, helps you meet UDI requirements and allows you to submit your data through a single pathway designed to accommodate future data submission needs. In addition, GHX consulting experts can help you organize internal teams, processes, and data governance into a sustainable compliance program to achieve better UDI data management.


  • Meet FDA GUDID submission requirements
  • Update GUDID submissions as product attributes change to meet UDI requirements
  • Prepare for FDA audit and compliance reviews with documentation and evidence of system and data integrity


  • Holistic solution that generates the required Health Level 7 (HL7) Structured Product Labeling (SPL)-formatted submission data, transmits it to GUDID, and tracks FDA responses back to each submission
  • Data staging, pre-submission data validation and bi-directional workflow technology to provide unique data management and synchronization capabilities
  • SaaS model for ease of implementation and ongoing maintenance


GHX and PTC: Proven track records in healthcare and UDI submission


  • Operates the largest product data repository in healthcare, synchronizing it across all supply chain participants (suppliers, providers, GPOs and distributors)
  • Offers the only GDSN-certified data pool (GHX Health ConneXion Data Pool) focused solely on the healthcare industry
  • Maintains ongoing relationships with healthcare and regulatory groups affiliated with global data standards in healthcare (dating back to 2000), and specifically with the GUDID (dating back to 2010)
  • Continues to play an active role in FDA efforts to develop and test the GUDID; assisted with the 2009 pilots to test the usability and feasibility of the prototype UDI database, as well as the 2013 GUDID user acceptance tests


  • Offers a full suite of solutions for Product Lifecycle Management (PLM), Quality Management System (QMS), Reliability and Risk Management, CAD, Service Lifecycle Management (SLM), and Application Lifecycle Management (ALM), employed by some of the world’s largest medical device manufacturers
  • Worked alongside the FDA and industry-leading medical device manufacturers over the past three years to develop the technology behind the GHX UDI Submission Service
  • Provides technologies and training to help you meet the requirements of the UDI rule and FDA submission requirements under 21 CFR Part 11 Conducted hundreds of successful test submissions to the FDA’s pre-production GUDID

Your Path to GUDID Submission

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