Life Sciences
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...
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 Identification (UDI) for Medical Devices” (MDS-G34) (MDS-G34 at HIBCC) in Apri l 2019. The guidance published an update in December 2019 and a third update...
Webinar Recording: Blanket No-Change Certification-5 Steps for a Successful Submission
Register to see the recording. Thank you! The Blanket No Change Certification was introduced in 2017 when the FDA published the ‘Final Labeling Rule’: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs. This rule...
Reed Tech SingleSource™ for Drug Products – New Enhancements
SingleSource™ for Drug Products helps regulatory professionals manage drug product meta-data with an intuitive interface, filters, and prompts. With new enhancements soon to be released, SingleSource™ for Drug Products is even more intuitive and...
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
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)
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...
Webinar Recording: What You Need to Know for Med Device UDI Submission to China
5:03 Webinar Recording Excerpt To prepare the world market for regulatory compliance in China, NMPA has published guidance on medical device UDI submission for specific product classes. A UDI pilot began in 2019 and has continued to the present. Published guidance is...
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
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
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...
Navigator for Drug Labels: Faster product label creation means faster time to market for rare-disease drug manufacturer
Katelyn Zumpino, Account Executive with the Life Sciences sales team at Reed Tech, shares a front-line perspective on the value of Reed Tech Navigator™ for Drug Labels for a rare-disease biopharmaceutical manufacturer. In working with life sciences customers, I...
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...
Webinar Recording: Updates to Health Canada’s New XML Product Monograph Launch. What you need to know and do.
Gary Saner, Sr. Manager of Information Solutions at Reed Tech Life Sciences and a subject matter expert on Drug Labeling, FDA regulations and other regulatory agencies and Jon Nolan, Associate Product Manager for Reed Tech Life Sciences Structured Product Labeling...
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...
Webinar Recording: Update Your Medical Device UDI Data & Labels-This Year FDA Class I | Next Year EU MDR
3:55 Webinar Recording Excerpt When you’re involved with the regulatory requirements in the medical device industry, deadlines are usually on the horizon. Join speakers from Reed Tech Life Sciences and NiceLabel® for a review of what you need to know and take...
Webinar Recording: How Medical Device Classification and Identification Impact the Device Lifecycle
4:06 Webinar recording excerpt Review this educational virtual panel discussion of ‘How Medical Device Classification and Identification Impact the Device Life Cycle’. Speakers from Reed Tech, Greenlight Guru and GMDN Agency discuss the topic and take...
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...
Webinar Recording: Drug Pregnancy & Lactation Labeling Rule (PLLR) Best Practices to pass FDA validation
...
How does a Medical Device Product Data Pool Work?
Why your product data needs to be in GDSN…NOW! If you manufacture medical devices, you know the challenges in managing accurate, current, and complete product data and sharing it with your trading partners. Your data consumers, both internal and external, trust your...
Electronic Drug Registration & Listing Process (eDRL). A How-to Guide for OTC Distributors
Why your product data needs to be in GDSN…NOW! If you manufacture medical devices, you know the challenges in managing accurate, current, and complete product data and sharing it with your trading partners. Your data consumers, both internal and external, trust your...
