American National Standards Institute (ANSI) has recognized the HIBCC for “stepping up with guidance, resources, and initiatives to support public health, safety, and infrastructure during the COVID-19 outbreak.” To view the full publication on ANSI’s website click here. HIBCC has been an ANSI-accredited Standards Development Organization (SDO) since 1995. To learn more about how HIBCC […]
March 25, 2020 the European Commission announced that they are working on “a proposal to postpone the date of application of the MDR for one year”. The proposal is expected to be submitted to the European Parliament in early April. The postponement seeks to “temporarily alleviate the burden on available resources” in the healthcare industry […]
As the outbreak of the Coronavirus (COVID-19) continues to rapidly evolve, HIBCC remains focused upon playing its part in ensuring that necessary medical devices and pharmaceuticals will move through their supply chain unhampered. HIBCC’s Health Industry Number (HIN) is used by the vast majority of pharmaceutical and medical device suppliers to facilitate the necessary “electronic […]
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 […]
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. […]
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.
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 […]
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 […]
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 […]
The European Commission released version 5.0 of the EUDAMED Data Dictionary. This document provides an overview of the data fields and corresponding definitions that are to be provided to Eudamed and that can be communicated through the Data Exchange process for the UDI/Device module. To view the the EUDAMED Data Dictionary V5.0 click here. To […]
