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 […]
HIBCC named as UDI Issuing Agency. To read the full policy paper click here.
A new set of HIN Distribution files, as of March 30th, 2018, are now available for download. To download the periodic HIN Distribution from iHIN:???? Access iHIN at http://www.hibcchin.org/. Enter your username and password. Click on ???Download??? then ???Distribution Download???. Review the HIN Data Use License Agreement and enter your Subscriber Account ID. Click next. […]
As of April 1st, 2018, HIBCC will no longer accept HIN requests submitted via email. All HIN requests must be submitted through the iHIN portal at www.hibcchin.org. Requests submitted via email frequently require manual intervention by HIBCC prior to processing, which increases turn-around times and our backlog. Please review the updated HIN Request Submission Guidelines […]
