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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United Kingdom (UK) regulatory agency publishes HIBCC UDI template for use in medical device corrective action communications
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.
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 →
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
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 →
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 →
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 →
- 14 Sep 2020HIBCC Announces HIN Data integration within the MediLedger Network
- 18 Aug 2020EC releases updated MDR / IVDR UDI FAQs
- 28 Jul 2020Register now for our second HIBCC UDI Webinar
- 27 Jul 2020EC releases conformity assessment procedures for manufacturers of protective equipment
- 15 Jun 2020Register now for our HIBCC UDI Webinar