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Medical Device Classifications in Global Markets and Health …

WEBThe health authorities in this blog are served as active channels for machine-to-machine submissions via Reed Tech SingleSource™ for Medical Devices. …

Actived: 4 days ago

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

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 …

Category: Health Go Health

Navigating the AusUDID Rollout: A New Era for Medical Device

WEBQuestions about health authorities and Unique Device Identification (UDI)? We monitor health authorities around the globe for the latest requirements and …

Category: Health Go Health

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

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. …

Category: Health Go Health

Combination Product: What to Consider for both Medical Device …

WEBIn this scenario, the combination product was reviewed by the Center for Devices and Radiological Health (CDRH) and cleared under a 510(k). The combo …

Category: Health Go Health

DIA Global Labeling Takeaways: Patient Materials and Health …

WEBHealth Literacy focuses on both the patient and the health system for a variety of benefits including prevention of the unsafe and inappropriate use of medicines. …

Category: Medicine Go Health

Preparing, Managing and Monitoring Medical Device UDI

WEBYes, I spend my workdays with questions about UDI and managing product data. It is a process. First, gain an understanding of the Health Authority requirements. …

Category: Health Go Health

Reed Tech® Introduces Reed Tech SingleSource™ for Medical …

WEBSingleSource for Medical Devices manages and reports regulatory Unique Device Identification (UDI) information to health authorities worldwide and publishes …

Category: Medical 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 …

Category: Health Go Health

Health Canada Now Requiring Second-Language at Post …

WEBEffective March 10, 2023, Health Canada changed submission requirements for second-language product monographs for human drugs. This change no longer requires the …

Category: Health Go Health

Health Canada Releases XML PM Draft Guidance

WEBHealth Canada XML PM Background. In the draft guidance, Health Canada states the following background: The PM provides the necessary information for the safe …

Category: Health Go Health

Knowledge Center Main Page

WEBLexisNexis Reed Tech was pleased to sponsor, present, and attend the recent IBA (International Beauty Association) Cosmetics Convergence Spring Symposium. In …

Category: Health Go Health

EU’s Requirement for Implant Cards Provides Key Information for

WEBJul 27, 2021 | Medical Device Safety and Quality, Medical Devices, Unique Device Identification. The European Union (EU) requires manufacturers to supply ‘implant …

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

UDI Labeling (Unique Device Identification): Best Practices

WEBUnique Device Identification (UDI) labeling remains a hot topic among medical device manufacturers under pressure to comply with UDI requirements for US …

Category: Medical Go Health

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 …

Category: Health Go Health

Overview of Pharma Annual Deadlines and Requirements

WEBIn addition to FDA, Health Canada is in the process of capturing product monograph (PM) data in structured XML format. Industry is currently in phase II – …

Category: Health Go Health

FDA has Updated eCTD Guidance to Recommend Structure-Data …

WEBThe Electronic Common Technical Document, commonly referred to as eCTD, is a standard format for submitting regulatory applications, amendments, …

Category: Health Go Health

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, …

Category: Health Go Health

Understanding FDA Exemptions to Unique Device Identification …

WEBAt Reed Tech, we specialize in medical device product data requirements for global health authorities. UDI can become overwhelming without experienced guidance. …

Category: Medical Go Health