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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HIBCC releases new website page on HIN and DSCSA
HIBCC has released a new page on the www.hibcc.org website for how to utilize HIN for the Drug Supply Chain Security Act (DSCSA). The page will be regularly updated with HIBCC guidance for satisfying DSCSA requirements. To view the page click here. To learn more about how HIBCC and how the HIN System can be.. read more →
The European Commission releases updated guidance document on Basic UDI-DI and Changes to UDI-DI
The European Commission released the third version of the Medical Device Coordination Group’s (MDCG) “Guidance on Basic UDI-DI and Changes to UDI-DI” document. The new version includes additional information on devices that are directly marked and the manner in which the production of the device is controlled. To view the updated guidance document click here… read more →
HIBCC Presentation “Using Health Industry Number (HIN) Tools for 340B and DSCSA” Now Available Online
Download the full HIBCC Presentation. Event Name: 2020 Distribution Management Conference and Expo To learn more about HIBCC and the HIN System, visit www.hibcc.org or contact HIBCC directly at info@hibcc.org or +1 (602) 381-1091. read more →
Notice to Labelers: HIBCC Contact Information
HIBCC has consolidated its various points of contact to assure uniform compliance with the European Union and the US FDA UDI regulations, for which we have been designated as the Issuing Entity and Issuing Agency respectively. Accordingly, we have assumed all LIC assignment and maintenance responsibilities. Labelers are asked to direct their communications and inquiries.. read more →
The European Commission announces the European Medical Device Nomenclature (EMDN)
The European Commission announced that the European Medical Device Nomenclature (EMDN) will be the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. The EMDN is based on the Italian Classificazione Nazionale Dispositivi medici (CND). To view the European Commission statement on EMDN click here. To view the Classificazione Nazionale.. read more →
How to use HIN for Drug Supply Chain Security Act (DSCSA) requirements
The FDA introduced DSCSA as the federal framework to address supply chain security for prescription drugs distributed in the United States. DSCSA aims to protect consumers from counterfeit and/or contaminated drugs by aiding in the detection and removal of danger substances from the supply chain. DSCSA outlines the steps to build an electronic, interoperable system.. read more →