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 5, 2017 the European Parliament adopted two new regulations on medical and in-vitro diagnostic devices. The new EU rules focus on??enhancement of patient safety and the modernization of the overall public health system. To read the official European Commission press release click here.
The FDA has extended the compliance date for UDI labeling and data submission??requirements to September 24, 2018 for the class II devices listed below. All other class II devices are subject to the September 24, 2016 UDI compliance date. Collections of two or more different devices packaged together in which the devices in the package […]
The draft guidance??was issued to provide clarification on the UDI labeling requirements. To download the draft guidance on Form and Content of the UDI click here. To learn more about HIBCC as an FDA-accredited UDI issuing agency click here.
To view the latest revision of the proposed Regulation on medical devices??Click Here
For more information??Click Here
To complete the form??Click Here
