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ICCBBA Recognized by the TGA

  • Writer: roberteich
    roberteich
  • 6 days ago
  • 2 min read

Updated: 3 days ago


ree

We are very pleased to announce that the Therapeutic Goods Administration (TGA) of Australia has officially recognized ICCBBA as a Unique Device Identifier (UDI) issuer. The Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 now lists ICCBBA alongside GS1 and HIBCC after an Issuing Agency Deed was signed last week.


Recognition by the TGA aligns with similar acceptance by FDA, European Union and the Saudi FDA and is a clear example of effective regulatory convergence. 


ICCBBA manages and maintains the ISBT 128 Standard, which specifies for a UDI the coding and labeling of Medical Products of Human Origin (MPHO) that are regulated as a medical device, or medical devices containing a MPHO component. The ISBT 128 DI includes three elements: a Facility Identification Number, a Facility-defined Product Code, and the ISBT 128 standardized Product Description Code (PDC). For more information on the structure and requirements for an ISBT 128 UDI, please see the guidance provided within the document ISBT 128 Standard Coding and Labeling of Medical Devices Containing MPHO (ST-017).


For any questions, please contact us at our Help Desk.



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About ICCBBA:  

ICCBBA is the international standards organization responsible for the management and development of the ISBT 128 Standard.

 

The acronym ISBT was originally derived from the important role played by the International Society of Blood Transfusion in the development of the standard. Today, it expands as Information Standard for Blood and Transplant. The number 128 reflects the 128 characters of the ISO/IEC 646 7-bit character set.


The acronym ICCBBA is derived from the International Council for Commonality in Blood Banking Automation.

 


For More Information About ICCBBA: 

 

Press Contact:

Christina Salinas




Author 

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Creative Services Coordinator, ICCBBA

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