HIBCC establishes EU-MDR mailbox

August 16, 2019
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HIBCC has established a new mailbox – udisupport@hibcc.eu – for inquiries and technical support related to the European Union Medical Device Regulation (MDR). The use of this mailbox will streamline requests for both new EU-MDR registrations and support for existing users. read more →

EHIBCC website consolidated with HIBCC Global

July 26, 2019
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The EHIBCC website, formerly www.ehibcc.com,  has been consolidated with that of HIBCC Global. 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. To learn more about HIBCC and UDI, visit www.hibcc.org.. read more →

HIBCC Welcomes Pakistan-Based Affiliate

July 2, 2019
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HIBCC is pleased to announce that it has appointed a Pakistan-Based affiliate organization, in cooperation with QMSCI (Quality Management System Certification International), a long-standing regulatory and engineering consulting company that is headquartered in Sialkot, PK and also has offices in several other countries.  QMSCI has created a new organization, HIBCC Pakistan (HIBCC PK).  HIBCC PK.. read more →

HIBCC UDI Suite Enhancements

June 21, 2019
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HIBCC UDI Suite’s Calculate Check Character function has been updated to allow users to calculate multiple UDI / bar code data check characters at a time. This is a tool provided to all HIBCC Labelers. Click here to access the updated utility. Follow the instructions below to use the updated utility. 1. Enter the UDI/Bar.. read more →

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 →