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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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. read more →
On March 30, 2017, the FDA released a statement granting a UDI compliance extension for labelers of soft (hydrophilic) contact lenses. To view the extension letter click here. read more →
It has been brought to our attention that some HIBCC clients are recieving emails from a Madison Brady claiming to be a HIBCC employee. The emails are coming from email@example.com and contain a PDF attachment. This individual and email address is in no way associated with HIBCC. Do not open the PDF attachment, as it.. read more →
On March 7th, 2017 the Council of the European Union approved two new medical device regulations, including a regulation similar to the US FDA’s UDI rule. The European Parliament is expected to adopt both regulations in April 2017. To view the EU press release click here. read more →
In order to expedite the processing of licensee requests for HINs, HIBCC has implemented a process to return all completed records in a partially completed work order to licensees. This system enhancement enables licensees to receive their data faster than ever. HIBCC is also encouraging licensees to consolidate work orders by sending all HIN requests.. read more →
A new set of HIN Distribution files, as of December 31, 2016, 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. The.. read more →
- 19 Feb 2019Medical Technology Association of Australia (MTAA) releases final UDI System Proposal
- 05 Feb 2019MedTech Europe releases document on the differences in UDI requirements for the US and EU
- 29 Nov 2018HIBCC designated by the Saudi-Arabian FDA as a UDI Issuing Agency in Draft Regulation
- 23 Oct 2018HIBCC met with European Commission and FDA in Silver Springs, MD on October 17th
- 16 Jul 2018Deactivation of iHIN Guest Accounts