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Medical Device Classifications in Global Markets and Health …

WEBSouth Korea regulations classify medical devices into four groups, based on increasing risk. The MFDS lists the following classifications with examples of non-IVD …

Actived: 4 days ago

URL: https://www.reedtech.com/knowledge-center/medical-device-classifications-in-global-markets-and-health-authorities/

LexisNexis Reed Tech is proud to be recognized by the Dental …

WEBHORSHAM, Pa., May 18, 2021 /PRNewswire/ — Reed Technology and Information Services Inc. (Reed Tech™), a leading provider of data management and analytics …

Category: Health Go Health

About Us Regulatory Professionals in Medical Devices, Rx, OTC

WEBThe Reed Tech Life Sciences team has an employee sitting on the standards setting board of this organization. Health Level Seven International (HL7) is a not-for-profit, ANSI …

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Reed Tech Best-In-Class Information-Based Solutions and Services

WEBReed Tech serves many of the world’s top pharmaceutical labelers and medical device manufacturers. Our customers range from small to mid-size producers and distributors …

Category: Medical Go Health

A Closer Look at the FDA’s UDI Guidance: Which

WEBClear identification can also improve the standardization of the appropriate use of medical devices. Convenience kits – which FDA defines as “two or more different …

Category: Medical Go Health

What’s Been Happening with Health Canada XML PM Mandates

WEBThe above graphic (used in the webinar presentation) explains the process of creating and submitting your Health Canada XML Product Monograph Information. …

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Combination Product: What to Consider for both Medical Device …

WEBAbout LexisNexis Legal & Professional . LexisNexis Legal & Professional® provides legal, regulatory, and business information and analytics that help customers …

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4 Questions to Ask Before Choosing a UDI Issuing Agency

WEBAs Implantable, Life-Sustaining and Life Supporting (I/LS/LS) and Class II medical device labelers have complied with the FDA’s final rule on Unique Device …

Category: Medical Go Health

Knowledge Center Main Page

WEBAs we continue to discuss optimal solutions to support the growth and compliance needs of industry, LexisNexis Reed Tech is committed to providing you with a single UDI vendor …

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New Drug Application (NDA): Back to the Basics

WEBAccording to the FDA, “The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and …

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Reed Tech® Introduces Reed Tech SingleSource™ for Medical …

WEBHORSHAM, Pa., March 25, 2019 /PRNewswire/ — Reed Technology and Information Services Inc. (Reed Tech), a leader in data management and analytic services and …

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SPL & XML Services for Rx, OTC, and Biologics

WEBHealth Canada will start to accept drug monographs in XML format on a “by request” basis April 1 – July 31, 2020, with voluntary launch to begin by Spring 2021. Reed Tech knows …

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Medical Device Regulatory Requirements – Japanese Guidelines

WEBWe monitor health authorities around the globe for the latest requirements and exceptions. If you have UDI questions, we can help. Email us: …

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Unique Device Identification (UDI)

WEBReed Tech is a leading FDA supplier of Unique Device Identification (UDI) information, submitting close to one-quarter of all NLM Access GUDID UDI records annually, …

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Health Canada Releases XML PM Draft Guidance

WEBFollowing a lengthy period of anticipation, Health Canada has released Draft Guidance Document Preparation of the Product Monograph in Extensible Markup …

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UK NHS eProcurement: The What, Who, Why and When

WEBNevertheless, eProcurement is a requirement for any organization that wants to do business with an NHS care provider. For most device companies operating in the …

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FDA has Updated eCTD Guidance to Recommend Structure-Data …

WEBIn November of 2022, the Federal Drug Administration (FDA) published a new version of the eCTD TECHNICAL CONFORMANCE GUIDE, amending it to include …

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