HIBCC Industry News

HIBCC Industry News

Although our scope has expanded beyond the initial HIBC labeling mandate issued 30 years ago, we have continued to emphasize ‘safety first’ through the years.

As such, the Health Industry Business Communication Council has an important advocacy and educational role in today’s healthcare industry. We are proud to act as the forum through which consensus can be reached as all parties work together to ensure a safer, more efficient industry.

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Saudi Food and Drug Authority Releases Guidance Designating HIBCC as an Issuing Entity

May 6, 2019
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The Saudi Food and Drug Authority (SFDA) has released its “Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices” designating HIBCC as an Issuing Entity. The initial release date was April 8th, 2019. To view the full guidance document click here. To learn more about UDI contact HIBCC at info@hibcc.org read more →

FDA Releases Final Guidance on Convenience Kits

May 1, 2019
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On April 26th, 2019 the FDA published the finalized UDI guidance document for Convenience Kits. The draft was previously published in 2016. To view the complete guidance document click here. To learn more about UDI contact HIBCC at info@hibcc.org read more →

HIBCC Releases UDI Suite

April 8, 2019
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Create, Calculate, and Confirm UDI Information with HIBCC’s suite of cloud-based tools. How do I Create a UDI? This on line utility will generate a UDI from the product information you enter.   In combination with your HIBCC LIC the Creator tool will provide you with the correct data combination for printing on packages and to.. read more →

The Global Medical Device Nomenclature (GMDN) Membership is now available for free as of April 1st

April 3, 2019
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The GMDN, the de facto global standard for identifying the world’s millions of medical devices, has been made freely available to all users for the first time on 1st April 2019. Click here to view the GMDN press release. read more →

Need to Make a Change to a Published UDI Record in the FDA’s GUDID?

March 26, 2019
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Click here to view the FDA’s guidance for Unlockling a UDI Record in the GUDID. read more →

Medical Technology Association of Australia (MTAA) releases final UDI System Proposal

February 19, 2019
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Medical Technology Association of Australia (MTAA) releases final submission to the “TGA Consultation: Proposal to introduce a UDI system for medical devices in Australia. To view the document click here. To learn more about UDI click here or contact HIBCC at info@hibcc.org. read more →