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