Being able to identify, track and trace medical devices at a global level is important for patient safety. To help achieve this, the US FDA (Food and Drug Administration) has established a Unique Device Identification (UDI) system for medical devices in the US. Similar regulations to the FDA mandate are expected to follow globally, and Taiwan Food and Drug Administration’s (TFDA) has announced UDI Directive in Oct 2015. Now, suppliers and manufacturers of medical devices can easily adapt to these changes through GS1 standards.
As the industry benchmark in healthcare,GS1 has been accredited by the FDA as an issuing agency for UDIs and our standards for identification and barcoding conform to all UDI requirements, including:
• Product identification at each level of the packaging hierarchy
• The barcode symbols to use
• The product data to be included in barcodes
• The data that must be stored within the Global UDI Database (GUDID)
As working with TFDA for more than 3 years, we are ideally placed to ensure you will comply with related requirements that will follow. This issue, we have invited Invited Changhua Christian Hospital import hospital UDI introduced pilot case, and showed the prototype of domestic UDI information platform. We also asked key technology suppliers to provide some actionable plans on how to comply with UDI regulations.
In the further, UDI system will be the important tool for related authorities and medical devices manufacturers and supplier are required to upload and maintain licensed products, including product identification code (DI) and associated information available in the public use, in order to achieve the purpose of importing UDI. GS1 Taiwan will continue working with industry experts to provide you with a full understanding of UDI regulations and how GS1 standards will ensure compliance.