GHTF Publishes Unique Device Identification Guidance for Regulators

The Global Harmonization Task Force (GHTF) has issued final guidance on developing a global Unique Device Identification (UDI) system for medical devices.

The GHTF lays out fundamental concepts any UDI system established by a medical device regulator should follow in order to ultimately reach a truly worldwide framework:

  • UDI should be based on global standards
  • A UDI used for a device in one market should meet the requirements of any other market authority in the world
  • National or local identification numbers cannot be used as UDI numbers
  • No regulatory authority should specify how to modify UDI standards
  • Core elements of the UDI Database are not to be modified
  • Data Exchanges on the UDI Database should be conducted using HL7 SPL

Establishing a global UDI system, argues the GHTF, would enhance the traceability of devices throughout their distributions, as well as the ability to identify devices involved in adverse events and documentation and data capture of devices.

The GHTF guidance emphasizes that in order for a harmonized, global UDI framework to properly take effect, any medical device regulator implementing its own system will need to adhere to these recommendations.