European Commission Designates HIBCC as an Issuing Entity for its UDI Initiative

June 12, 2019
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The European Commission has designated HIBCC to be a Unique Device Identifier (UDI) Issuing Agency as part of the European Union Medical Device Regulation (MDR), which will apply to all EU member nations.   HIBCC’s EU Issuing Entity designation was announced on June 7th, 2019. HIBCC has been an Issuing Agency for the U.S. FDA’s UDI.. read more →

iHIN® Web Based Portal Enhancement and New Processes Scheduled

May 16, 2019
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Licensees will be able to create and manage their own Customer HIN List on iHIN® Updated HIN submission processes and guidelines Enhanced search HIN options and HIN results list On Friday (5/17/2019) at 12pm EST, HIBCC’s iHIN Web Based Portal will be temporarily shut down for scheduled maintenance and to implement several enhancements, as described.. read more →

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 →

MedTech Europe releases document on the differences in UDI requirements for the US and EU

February 5, 2019
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MedTech Europe released a document last week that highlights the differences in the US UDI and EU UDI system requirements. To view the document click here. To learn more about UDI click here or contact HIBCC at info@hibcc.org. read more →

HIBCC designated by the Saudi-Arabian FDA as a UDI Issuing Agency in Draft Regulation

November 29, 2018
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To view the Saudi-Arabian FDA’s Draft Requirements for the Unique Device Identification System click here. To learn more about UDI click here or contact HIBCC at info@hibcc.org. read more →