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.
May 29, 2018
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April 6, 2018
HIN Distribution Files Available Online
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. […]
March 19, 2018
Updated HIN Submission Process effective April 1, 2018
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 […]
January 5, 2018
HIN Distribution Files Available Online
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. […]
September 12, 2017
HIN Distribution Files Available Online
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. […]
July 3, 2017
HIN Distribution Files Available Online
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. […]
June 5, 2017
FDA Extends UDI Compliance Deadline for Class 1 Devices
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.
May 26, 2017
FDA Posts New Webpage on Use of Symbols in Labeling
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.
April 7, 2017
European Parliament Votes to Adopt Medical Device Regulation Proposal
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.
April 3, 2017
FDA Grants UDI Extension for Soft Contact Lenses
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.