Australian medical device industry bodies release joint policy paper to promote the adoption of UDI.

May 29, 2018
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HIBCC named as UDI Issuing Agency. To read the full policy paper click here. read more →

Updated HIN Submission Process effective April 1, 2018

March 19, 2018
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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.. read more →

HIN Distribution Files Available Online

January 5, 2018
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A new set of HIN Distribution files, as of January 4, 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 →

HIN Distribution Files Available Online

September 12, 2017
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A new set of HIN Distribution files, as of September 12, 2017, 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 →

HIN Distribution Files Available Online

July 3, 2017
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A new set of HIN Distribution files, as of June 30, 2017, 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 →

FDA Extends UDI Compliance Deadline for Class 1 Devices

June 5, 2017
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The FDA has extended the UDI compliance deadline for Class 1 and Unclassified devices to September 24, 2020 for both labeling and GUDID submissions. To view the official FDA letter click here. read more →

FDA Posts New Webpage on Use of Symbols in Labeling

May 26, 2017
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The FDA Final Rule on Use of Symbols in Labeling allows the use of symbols without explanatory text. To learn more click here to be taken to the Use of Symbols in Labeling webpage. read more →

European Parliament Votes to Adopt Medical Device Regulation Proposal

April 7, 2017
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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 →

FDA Grants UDI Extension for Soft Contact Lenses

April 3, 2017
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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 →

Malware Alert for HIBCC Clients

March 30, 2017
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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 madisonalbrady@gmail.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 →