Register now for our HIBCC UDI Webinar

June 15, 2020
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To register click here. HIBCC is designated as an Issuing Entity by both the European Commission and the US FDA for their respective UDI initiatives. To learn more about HIBCC and UDI, visit www.hibcc.org or contact HIBCC directly at info@hibcc.org or +1 (602) 381-1091. read more →

MedTech Europe releases guidance on Basic UDI-DI assignment for the EU MDR

June 3, 2020
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MedTech, the European trade association for the medical technology industry, published a document to provide guidance on the assignment of Basic UDI-DIs. The Basic UDI-DI is a required element of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). The Basic UDI-DI will be included in the EU’s EUDAMED database and is referenced.. read more →

United Kingdom (UK) regulatory agency publishes HIBCC UDI template for use in medical device corrective action communications

May 28, 2020
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The UK Medicines & Healthcare Products Regulatory Agency (MHRA) utilizes global UDI standards to communicate device safety information and corrective actions. Manufacturers are required to send Field Safety Notices (FSNs) and Field Safety Corrective Actions (FSCAs) to device users. MHRA “considers it best practice to include unique device identifiers (UDIs) in field safety corrective action.. read more →

FDA UDI labeling and database submission deadline for Class I and unclassified devices rapidly approaching.

May 26, 2020
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The US FDA UDI compliance deadline for Class I and unclassified devices is September 24, 2020. All labels and packages of all Class I and unclassified devices must bear a UDI , and the UDI must be submitted to the FDA’s Global UDI Database (GUDID) by the compliance deadline. To view the FDA UDI compliance.. read more →

European Commission publishes guidance document on regulatory requirements for ventilators

April 29, 2020
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Due to the global COVID-19 pandemic and the increased need for ventilators, the European Commission has published a guidance document on the regulatory requirements for ventilators and related accessories. The document “outlines the different regulatory options for placing these devices on the EU market indicating their feasibility to allow short term supply.” To view the.. read more →

Chronicled’s Mediledger utilizing the HIBCC HIN identifier for Contracting and Chargebacks in its’ blockchain network

April 15, 2020
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Chronicled is building an open, decentralized network, called the MediLedger Network , in response to the FDA’s Drug Security Supply Chain Act (DSCSA). The MediLedger Network will streamline communication and transactions between all trading partners. An important aspect of DSCSA and the MediLedger Network is identifying customers and their locations, and the HIN will serve.. read more →

HINAPI is now available

April 15, 2020
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HIBCC’s HIN Application Programming Interface (HINAPI) Service is now available. The HINAPI provides real-time HIN database integration with existing user systems and applications.   HIBCC’s HIN System is an integral part of the healthcare supply chain, and its expanding use has created the need for our licensees to be able to access and utilize HIN data.. read more →

HINAPI to be launched on April 15, 2020

April 7, 2020
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HIBCC will shortly offer its HIN Application Programming Interface (HINAPI) Service to provide real-time HIN database integration with existing user systems and applications.   HIBCC’s HIN System is an integral part of the healthcare supply chain, and its expanding use has created the need for our licensees to be able to access and utilize HIN data.. read more →

US Naval Ships Mercy and Comfort using HIN to expedite receiving pharmaceutical supplies to support NYC and LA hospitals fighting COVID-19

March 27, 2020
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HIBCC is working with the US DoD Defense Logistics Agency (DLA) Troop Support to expedite Health Industry Number (HIN) requests and updates.  The DLA is a long-time HIN user, and as it ramps up support of the COVID-19 relief effort, HIBCC has provided new HIN assignments for the DLA.   For example, HIBCC has recently created.. read more →

ANSI recognizes HIBCC support of the fight against COVID-19

March 27, 2020
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American National Standards Institute (ANSI) has recognized the HIBCC for “stepping up with guidance, resources, and initiatives to support public health, safety, and infrastructure during the COVID-19 outbreak.” To view the full publication on ANSI’s website click here. HIBCC has been an ANSI-accredited Standards Development Organization (SDO) since 1995. To learn more about how HIBCC.. read more →