Global Health Authorities

Unique Device Identification (UDI) Data Submission Compliance

US FDA, EU EUDAMED, China NMPA, South Korea IMDIS and development of future health authority channels for activation.

Learn more about Reed Tech SingleSource for Medical Devices.

FDA Class I UDI Submission Deadline

Class I devices and devices that have not been classified into class I, class II or class III that are required to be labeled with a UDI code, must submit product data to the FDA’s GUDID by September 24, 2022.

Health Canada Submissions

Gain insights into the forthcoming XML Product Monograph regulations and requirements for drug products in Canada.

Reed Tech Insights: EU Legacy Devices Series

In this series of 6 videos, Gary Saner, Sr Mgr Information Solutions at Reed Tech, does a deep dive into ‘What to Know’ concerning EU Legacy Devices for both MDR/IVDR, description, provisions, requirements and timelines. 

Global Health Authorities

Unique Device Identification (UDI) Data Submission Compliance

US FDA, EU EUDAMED, China NMPA, South Korea IMDIS and development of future health authority channels for activation.

Learn more about Reed Tech SingleSource for Medical Devices.

FDA Class I UDI Submission Deadline

Class I devices and devices that have not been classified into class I, class II or class III that are required to be labeled with a UDI code, must submit product data to the FDA’s GUDID by September 24, 2022.

Health Canada Submissions

Gain insights into the forthcoming XML Product Monograph regulations and requirements for drug products in Canada.

Reed Tech Insights: EU Legacy Devices Series

In this series of 6 videos, Gary Saner, Sr Mgr Information Solutions at Reed Tech, does a deep dive into ‘What to Know’ concerning EU Legacy Devices for both MDR/IVDR, description, provisions, requirements and timelines.

Leverage Our Expertise in Life Sciences

LexisNexis Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry’s data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.

Medical Devices

%

~% of FDA GUDID Electronic Records Submitted Annually

Medical Device unique customers since inception

Records Submitted to FDA Global UDI Database

Pharmaceuticals

Years of Structured Product Labeling Experience

Pharmaceutical customers including manufacturers

55,000+ Pharma FDA SPL submissions

What Our Customers Are Saying

“Reed Tech customer service is top-notch and very friendly, helpful and professional.”

-Regulatory Affairs & Compliance at an international provider of pharmaceutical, nutritional and veterinary products

What Our Customers Are Saying

“Excellent customer and technical support. Reed Tech is a true partner – an extension of our internal resources. Their software solutions are enabling us to successfully meet UDI compliance dates in the US and UK.”

– Regulatory Director at a premier provider of infection prevention and other procedural products and services

What Our Customers Are Saying

“Reed Tech has experts in Drug Listing and UDI and we can always count on them for their guidance for the best approach to be taken when needed.”

-Operations Head for a global medical device and pharmaceutical maker

What Our Customers Are Saying

The entire Reed Tech team has supported our numerous clients with SPL generation. Never once have they failed us!

– Operations Manager at Regulatory Professionals Inc.

What Our Customers Are Saying

“Reed Tech customer service is top-notch and very friendly, helpful and professional.”

-Regulatory Affairs & Compliance at an international provider of pharmaceutical, nutritional and veterinary products

What Our Customers Are Saying

“Excellent customer and technical support. Reed Tech is a true partner – an extension of our internal resources. Their software solutions are enabling us to successfully meet UDI compliance dates in the US and UK.”

– Regulatory Director at a premier provider of infection prevention and other procedural products and services

What Our Customers Are Saying

“Reed Tech has experts in Drug Listing and UDI and we can always count on them for their guidance for the best approach to be taken when needed.”

-Operations Head for a global medical device and pharmaceutical maker

What Our Customers Are Saying

The entire Reed Tech team has supported our numerous clients with SPL generation. Never once have they failed us!

–  Operations Manager at Regulatory Professionals Inc.

Medical Devices

Achieve UDI Submission with US FDA and Other Global Health Authorities

Build and submit UDI records electronically in Structured Product Labeling (SPL) format or seek subject-matter expertise.

Manage Medical Device Product Data for UDI & Syndication

Serving the medical device manufacturing industry in the areas of compliance, data management and regulatory requirements experience.

Gain Quick Insights Into Quality Safety and Regulatory Data

Navigator ™ for Medical Devices serves device manufacturers, law firms, consultants, investors, hospitals, insurers and more.

Pharmaceuticals (Rx, OTC, and Biologics)

Simplify Drug Label Research with Quick Access to Targeted Label Information

Navigator™ for Drug Labels helps pharmaceutical regulatory researchers ensure accurate and up-to-date drug label content.

Structured Product Labeling Services for Rx, OTC and Biologics

Manage product listing, establishment facility, and labeler company data across multiple teams with a secure cloud-based solution.

Manage Regulated Drug Product Data in One Central Database

SingleSource™ for Drug Products manages FDA prescription, OTC and animal drug product submissions data in Structured Product Labeling (SPL) format.

Downloadable Resources

Med Device Brochure

www.reedtech.com/udi

Pharma Brochure

www.reedtech.com/spl

Learn More About Regulatory Compliance and Product Data Management Solutions

More Resources

www.reedtech.com/udi

What to Know for Medical Device UDI Compliance in South Korea

South Korea Ministry of Food and Drug Safety (MFDS) began UDI activity in 2018 with the MFDS notification No. 2020-29. 

www.reedtech.com/udi

Health Canada is adopting a structured product monograph format for the preparation, submission and approval of human prescription drugs marketed, sold or distributed in Canada.

hand sanitizer and face mask on a black background

To market medical devices in China, the regulatory process to comply with NMPA UDI may be unfamiliar, requiring experienced help.

hand sanitizer and face mask on a black background

To bring a medical device to market in the European Union, there are a number of complex regulatory-related tasks that will need attention. 

Knowledge Center

Virtual Events & Recordings

Preparing Data for EUDAMED: A Virtual Panel

Thursday, October 21, 2021 | 11am EDT

Over-the-Counter Drug Product Monographs Webinar Series

Review a series of OTC-focused webinars featuring Reed Tech subject-matter experts and some of our industry friends and colleagues.

Recorded June-August, 2021

Recorded July 20, 2021

Recorded August 19, 2021

Recorded May 20, 2021

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