To assist you in determining which of your trading partners are eligible to receive HIN data, HIBCC maintains a current full list of all Authorized HIN Licensees on our website. Authorized Licensees are prohibited from disclosing any information contained in the HIN Database to any other individual, association, firm, parent or subsidiary organization that is […]
To assist you in determining which of your trading partners are eligible to receive HIN data, HIBCC maintains a current full list of all Authorized HIN Licensees on our website. Authorized Licensees are prohibited from disclosing any information contained in the HIN Database to any other individual, association, firm, parent or subsidiary organization that is […]
The European Commission (EC) released an updated Actor Module FAQ document (the original FAQ was published in November 2020). The changes include updated information on the national competent authorities registered in EUDAMED. The Actor Registration Module is the first of six interconnected modules in EUDAMED and enables economic operators to request an Actor ID/SRN (Single […]
To assist you in determining which of your trading partners are eligible to receive HIN data, HIBCC maintains a current full list of all Authorized HIN Licensees on our website. Authorized Licensees are prohibited from disclosing any information contained in the HIN Database to any other individual, association, firm, parent or subsidiary organization that is […]
To register for the HIBCC UDI Webinar: FDA UDI Labeling and GUDID Submission Requirements 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.
To assist you in determining which of your trading partners are eligible to receive HIN data, HIBCC maintains a current full list of all Authorized HIN Licensees on our website. Authorized Licensees are prohibited from disclosing any information contained in the HIN Database to any other individual, association, firm, parent or subsidiary organization that is […]
The FDA introduced DSCSA as the federal framework to address supply chain security for prescription drugs distributed in the United States. DSCSA aims to protect consumers from counterfeit and/or contaminated drugs by aiding in the detection and removal of danger substances from the supply chain. DSCSA outlines the steps to build an electronic, interoperable system […]
The European Commission (EC) released an FAQ document on the European Medical Device Nomenclature (EMDN). The EMDN is intended to support the functioning of EUDAMED and will be utilized during the UDI/Devices Registration Module. The UDI/Devices Registration Module is projected to be available to manufacturers beginning in September of 2021 (previously May 2021). To view […]
The European Commission (EC) released a guidance on the application and implementation of certain provisions in the Medical Device Regulation (MDR) in the absence of EUDAMED. This guidance “intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional.” In 2019 the EC announced that the […]
In March 2021 the European Commission released an infographic to assist manufacturers in determining whether their software qualifies as Medical Device Software (MDSW). The EU MDR definition of MDSW is “software that is intended to be used, alone or in combination, for a purpose as specifiedin the definition of a “medical device” in the MDR […]
