The United States Food and Drug Administration (FDA) had made patient safety a strategic priority by developing legislation for Unique Device Identification (UDI). UDI is expected to improve patient safety and Healthcare business processes. A single, global system of standards is fundamental to enable an efficient and effective implementation of UDI by all Healthcare stakeholders worldwide.
GS1 has received accreditation by the FDA as an issuing agency for UDIs. The global GS1 Standards meet the government’s criteria for UDIs. GS1 Standards are already in use by leading healthcare manufacturers, and are recognised across the healthcare industry as a unique identifier of medical/surgical products for every level of packaging.
Healthcare manufacturers around the world can create and maintain a compliant UDI number (i.e. GTIN) by following the requirements of the U.S. FDA UDI Rule and the GS1 General Specifications.
GS1 Malaysia provides GS1 UDI training to help local manufacturers to address requirements of the new FDA UDI regulation, which was published in September 2013.
Please contact GS1 Malaysia for more information.