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Reed Tech subject matter experts, Gary Saner, Information Solutions Senior Manager and Patti Shragher, Medical Device Senior Account Executive and Team Lead, host a webinar discussion dedicated to Unique Device Identification (UDI) requirements for health authorities...
(This blog was updated July 22, 2022) What is the Global Unique Device Identification Database, also known as GUDID? It is a database that contains key device information submitted to the FDA, including Unique Device Identifier (UDI) product data. Within the FDA...
For medical device manufacturers and distributors, UDI product data submission to Health Authorities/Regulators is a multi-step process with rules and goals, much like a ‘team sport’.
Unique Device Identification (UDI) labeling remains a hot topic among medical device manufacturers under pressure to comply with UDI requirements for US FDA GUDID and other emerging health authorities around the globe. EU EUDAMED is underway and China’s NMPA, South Korea and others have published guidelines. UDI is becoming integrated into medical device labeling all over the world. Medical Device manufacturers doing business globally will encounter growing regulatory complexity, while also ensuring quality, streamlined processes and cost control.
Take a ‘deep-dive’ into understanding and preparing medical device product data for EU EUDAMED UDI submissions. Learn more about the data attributes, regulatory, legislation and distinct differences between US FDA GUDID and EU EUDAMED.