May 16, 2019

by HIBCC in Uncategorized

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 […]

May 6, 2019

by HIBCC in Uncategorized

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

May 1, 2019

by HIBCC in Uncategorized

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

April 8, 2019

by HIBCC in Uncategorized

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 […]

April 3, 2019

by HIBCC in Uncategorized

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.

March 26, 2019

by HIBCC in Uncategorized

Need to Make a Change to a Published UDI Record in the FDA’s GUDID?

Click here to view the FDA’s guidance for Unlockling a UDI Record in the GUDID.

February 19, 2019

by HIBCC in Uncategorized

Medical Technology Association of Australia (MTAA) releases final UDI System Proposal

Medical Technology Association of Australia (MTAA) releases final submission to the “TGA Consultation: Proposal to introduce a UDI system for medical devices in Australia. To view the document click here. To learn more about UDI click here or contact HIBCC at info@hibcc.org.

February 5, 2019

by HIBCC in Uncategorized

MedTech Europe releases document on the differences in UDI requirements for the US and EU

MedTech Europe released a document last week that highlights the differences in the US UDI and EU UDI system requirements. To view the document click here. To learn more about UDI click here or contact HIBCC at info@hibcc.org.

November 29, 2018

by HIBCC in Uncategorized

HIBCC designated by the Saudi-Arabian FDA as a UDI Issuing Agency in Draft Regulation

To view the Saudi-Arabian FDA’s Draft Requirements for the Unique Device Identification System click here. To learn more about UDI click here or contact HIBCC at info@hibcc.org.

October 23, 2018

by HIBCC in Uncategorized

HIBCC met with European Commission and FDA in Silver Springs, MD on October 17th

HIBCC met with European Commission and FDA in Silver Springs, MD on October 17th to discuss the upcoming European Union Medical Device Regulation. HIBCC is recognized as a UDI Assigning Entity by the European Union. To learn more about UDI, contact HIBCC at info@hibcc.org.

HIBCC: Providing Global Healthcare Supply Chain Standards

iHIN® Web Based Portal Enhancement and New Processes Scheduled

Saudi Food and Drug Authority Releases Guidance Designating HIBCC as an Issuing Entity

FDA Releases Final Guidance on Convenience Kits

HIBCC Releases UDI Suite

The Global Medical Device Nomenclature (GMDN) Membership is now available for free as of April 1st

Need to Make a Change to a Published UDI Record in the FDA’s GUDID?

Medical Technology Association of Australia (MTAA) releases final UDI System Proposal

MedTech Europe releases document on the differences in UDI requirements for the US and EU

HIBCC designated by the Saudi-Arabian FDA as a UDI Issuing Agency in Draft Regulation

HIBCC met with European Commission and FDA in Silver Springs, MD on October 17th

HIBCC Labelers