UDI and Product Data
This page provides blogs, short videos and recordings focused on industry insights for regulatory requirements and best practices to manage medical device product data for established and newly formed Health Authority UDI mandates around the world.
Recent Blogs
China NMPA UDI and Device Registration Basics
In China, key regulatory policies originate with the State Council (Executive Branch). At the policy level,...
Why You Need a UDI Specialist
Did you know there are multiple health authorities around the globe with current or future requirements for medical...
How to Utilize an Authorized Representative in UDI Submissions to Health Regulators
For medical device manufacturers and distributors, UDI product data submission to Health Authorities/Regulators is a...
Unique Device Identification (UDI) Update for South Korea
Are UDI requirements in South Korea similar to other health regulators? The short answer is 'not exactly'. In this...
Evolution of UDI: A Look Back at RAPS 2020 Euro Convergence
Reed Tech attended RAPS 2020 Euro Convergence – this year live and online. We were able to connect virtually and share...
UDI Assignment for Spectacle Lenses & Readers in EUDAMED
Are makers of eyewear products subject to Unique Device Identification (UDI) requirements for compliance with EUDAMED?...
When is UDI required for drug-device combination products?
From the FDA point of view, there are some very nuanced rules about how UDI is applied to combination products. When...
Saudi Arabia (SFDA) Unique Device Identification Update for Med Device Manufacturers
Background Saudi Food and Drug Authority (SFDA) issued final “Guidance on Requirements for Unique Device...
UDI Labeling (Unique Device Identification): Best Practices
Unique Device Identification (UDI) labeling remains a hot topic among medical device manufacturers under pressure to...