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 →

HIBCC met with European Commission and FDA in Silver Springs, MD on October 17th

October 23, 2018
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HIBCC met with European Commission and FDA in Silver Springs, MD on October 17th to discuss the upcoming European Union Medical Device Regulation. HIBCC is recognized as a UDI Assigning Entity by the European Union. To learn more about UDI, contact HIBCC at info@hibcc.org. read more →

Deactivation of iHIN Guest Accounts

July 16, 2018
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HIBCC recently performed a clean-up of all accounts on the iHIN portal at www.hibcchin.org. Due to misuse of HIN data by unauthorized users, all Guest Accounts have been deactivated. To become a HIN Authorized Licensee please complete the appropriate application and Data Use License Agreement by clicking here. If you are currently a HIN licensee.. read more →

Australian medical device industry bodies release joint policy paper to promote the adoption of UDI.

May 29, 2018
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HIBCC named as UDI Issuing Agency. To read the full policy paper click here. read more →

Updated HIN Submission Process effective April 1, 2018

March 19, 2018
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As of April 1st, 2018, HIBCC will no longer accept HIN requests submitted via email. All HIN requests must be submitted through the iHIN portal at www.hibcchin.org. Requests submitted via email frequently require manual intervention by HIBCC prior to processing, which increases turn-around times and our backlog. Please review the updated HIN Request Submission Guidelines.. read more →