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Life Sciences

Life Sciences

Adaption and Innovation: RAPS 2020 Euro Convergence Recap

Adaption and Innovation: RAPS 2020 Euro Convergence Recap

Reed Tech attended RAPS 2020 Euro Convergence – this year live and online. Like most of 2020, conferences and trade shows have been all about adapting. Industry has done a commendable job of adjusting and embracing what is frequently referred to as the “new normal”...

Unique Device Identification (UDI) Update for South Korea

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 episode of Reed Tech Insights, we discuss the legislation, policy, timing and data attributes involved in the South Korean Unique Device...

What is UDI-DI and BUDI-DI?

What is UDI-DI and BUDI-DI?

What is UDI-DI? UDI stands for unique device identification. When using UDI, the labels of medical devices contain a UDI that can be found and read by both people and machines. The UDI contains both numbers and letters in a particular sequence. This includes the...

Stay Current with FDA Blanket No-Change Certification

Stay Current with FDA Blanket No-Change Certification

The fourth quarter of 2020 is fast approaching along with the Blanket No-Change deadline of December 31st. For drug manufacturers, action needs to be taken to keep product listings active before the calendar turns to 2021. What drug listings have to be updated? Every...

The Anatomy of a National Drug Code (NDC)

The Anatomy of a National Drug Code (NDC)

Per the Drug Listing Act of 1972, part of the Food and Drug Administration (FDA) requirement to electronically list drug products (Rx and OTC) includes the assignment of a National Drug Code (NDC). An NDC is a 10 digit number that uniquely and universally identifies a...

Electronic Drug Listing and Registration Guides

Electronic Drug Listing and Registration Guides

To learn the main requirements for Electronic Drug Registration and Labeling (eDRL), download a quick-reference guide with step-by-step instructions and ways to simplify and expedite the process. Download your free guide here. The eDRL How-to Guide answers questions...

UDI Labeling (Unique Device Identification): Best Practices

UDI Labeling (Unique Device Identification): Best Practices

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,...

Update: EUDAMED Actor Module Now Planned for December 2020

Update: EUDAMED Actor Module Now Planned for December 2020

EU EUDAMED Update Updates continue to be issued from both the European Commission and industry concerning EUDAMED in light of the current COVID-19 pandemic. The latest information sets new expectations about the availability of modules and expected activity. The...

UDI and 21 CFR Part 11

UDI and 21 CFR Part 11

Medical device manufacturers working to comply with the FDA’s Unique Device Identification mandate have more than one set of regulations to keep in mind. Fortunately, some of the regulations have been in place for some time and will be at least somewhat familiar to...

Your Response to the FDA Class I Medical Device UDI Delay

Your Response to the FDA Class I Medical Device UDI Delay

Update on FDA Class I UDI On July 1, 2020 the U.S. Food and Drug Administration (FDA) issued a Guidance document for labelers of Class I medical devices. In an effort to help the industry remain focused on high-quality Unique Device Identification (UDI) submissions...

Fact vs Fiction: UDI in China and Global Data Pools

Fact vs Fiction: UDI in China and Global Data Pools

Introduction The National Medical Products Administration (NMPA) is the regulating body in China for drugs and medical devices. The NMPA is the authoritative group that drafts laws and regulations for drugs, medical devices, and cosmetics. They also establish medical...

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