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 […]
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.
Click here to view the FDA’s guidance for Unlockling a UDI Record in the GUDID.
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.
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.
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.
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 recently performed a clean-up of all accounts on the iHIN portal at www.hibcchin.org. Due to misuse of HIN data by unauthorized users, all Guest Accounts have been deactivated. To become a HIN Authorized Licensee please complete the appropriate application and Data Use License Agreement by clicking here. If you are currently a HIN licensee […]
