HIBCC Industry News
Although our scope has expanded beyond the initial HIBC labeling mandate issued 30 years ago, we have continued to emphasize ‘safety first’ through the years.
As such, the Health Industry Business Communication Council has an important advocacy and educational role in today’s healthcare industry. We are proud to act as the forum through which consensus can be reached as all parties work together to ensure a safer, more efficient industry.
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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 email@example.com. read more →
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 firstname.lastname@example.org. read more →
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 email@example.com. read more →
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.. read more →
Australian medical device industry bodies release joint policy paper to promote the adoption of UDI.
HIBCC named as UDI Issuing Agency. To read the full policy paper click here. read more →
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… read more →
- 15 Jun 2020Register now for our HIBCC UDI Webinar
- 03 Jun 2020MedTech Europe releases guidance on Basic UDI-DI assignment for the EU MDR
- 28 May 2020United Kingdom (UK) regulatory agency publishes HIBCC UDI template for use in medical device corrective action communications
- 26 May 2020FDA UDI labeling and database submission deadline for Class I and unclassified devices rapidly approaching.
- 29 Apr 2020European Commission publishes guidance document on regulatory requirements for ventilators