HIBCC has updated its user account page to provide HIN users with the ability to add related identifiers to their Customer HIN Lists (CHLs). The CHL was designed to allow licensed HIN users to create and manage their customer HINs without having to search and sort the entire HIN database. Each CHL is specific to […]
HIBCC has established a new mailbox – udisupport@hibcc.eu – for inquiries and technical support related to the European Union Medical Device Regulation (MDR). The use of this mailbox will streamline requests for both new EU-MDR registrations and support for existing users.
The EHIBCC website, formerly www.ehibcc.com, has been consolidated with that of HIBCC Global. 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. To learn more about HIBCC and UDI, visit www.hibcc.org […]
HIBCC is pleased to announce that it has appointed a Pakistan-Based affiliate organization, in cooperation with QMSCI (Quality Management System Certification International), a long-standing regulatory and engineering consulting company that is headquartered in Sialkot, PK and also has offices in several other countries. QMSCI has created a new organization, HIBCC Pakistan (HIBCC PK). HIBCC PK […]
HIBCC UDI Suite’s Calculate Check Character function has been updated to allow users to calculate multiple UDI / bar code data check characters at a time. This is a tool provided to all HIBCC Labelers. Click here to access the updated utility. Follow the instructions below to use the updated utility. 1. Enter the UDI/Bar […]
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 […]
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 […]
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
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
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 […]
