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 →
US Naval Ships Mercy and Comfort using HIN to expedite receiving pharmaceutical supplies to support NYC and LA hospitals fighting COVID-19
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 →
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 →
European Commission delays its MDR by one year to focus on the Coronavirus, but leave labeling and database compliance deadlines unchanged.
March 25, 2020 the European Commission announced that they are working on “a proposal to postpone the date of application of the MDR for one year”. The proposal is expected to be submitted to the European Parliament in early April. The postponement seeks to “temporarily alleviate the burden on available resources” in the healthcare industry.. read more →
As the outbreak of the Coronavirus (COVID-19) continues to rapidly evolve, HIBCC remains focused upon playing its part in ensuring that necessary medical devices and pharmaceuticals will move through their supply chain unhampered. HIBCC’s Health Industry Number (HIN) is used by the vast majority of pharmaceutical and medical device suppliers to facilitate the necessary “electronic.. read more →