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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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 →