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Guide to International Medical Device Regulation

Contract Manufacturing, Industry News, Design, FDA, Devices

New edition include 150+ reports highlighting changes from the past year that will keep device makers growing in international markets.

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Manufacturing Group February 21, 2014

In medical device manufacturing, success means staying abreast of regulatory changes from Argentina to the United Kingdom... and beyond.

The 2014 edition of the Guide to International Medical Device Regulation

It’s the one-stop authority for quick, accurate answers to all questions on the fastest moving regulatory topics: 

  • New device regulatory frameworks in the EU, Japan and India
  • Changes in inspection practices, including the single audit program
  • Changes to quality manufacturing requirements
  • New IMDRF standards
  • Sunshine and transparency regulations
  • UDI requirements
  • Safety monitoring
  • Computer programs embedded in devices
  • Ever-changing registration requirements
  • And dozens more key topics in device regulation worldwide

International compliance is no longer simply a matter of following the same old rules. Enforcement activities and practices are changing. Countries are beginning to share data about manufacturing firms, increase the number of inspections and crack down on issues such as counterfeiting and improper marketing. Devicemakers learn the new rules of the game or cede the playing field to competitors.

That’s where the FDAnews Guide to International Medical Device Regulation – 2014 Edition comes in. Our editors monitor and report on regulatory developments affecting device production in more than 45 nations around the world. They’ve compiled more than 150 reports highlighting changes from the past year that will keep devicemakers growing in international markets.

Readers will turn to this total regulatory reference time and again in the months ahead. It will become the one-stop source for:

  • Coverage of the EU, Asia, Latin America, the Middle East, North America, and Australia/Pacific
  • Essential international regulatory changes from all of 2013
  • Comprehensive summaries and explanations of the changes
  • Key regulations – full-text printouts
  • And much more!

Format: Print or CD; Price: $387

Source: FDAnews

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