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FDAnews Guide to International Medical Device Regulation: 2013 Edition

Published: February 2013 |  Pages: 338 |  Price:  $387  | ISBN:  978-1-60428-096-8  | Table of Contents

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

Impossible? Not at all. Here’s how:

Announcing publication of the 2013 edition of the ...

FDAnews Guide to International Medical Device Regulation

It’s the one-stop authority for quick, accurate answers to all your questions on:

  • Premarket approval processes for new devices
  • Changes in inspection practices
  • Changes to quality manufacturing requirements
  • Emerging UDI requirements
  • Anti-counterfeiting measures
  • Safety monitoring
  • Computer programs embedded in devices
  • 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. You 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: 2013 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 could supercharge your international sales ... or stop them in their tracks.

You’ll turn to this total regulatory reference time and again in the months ahead. It will become your 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 2012
  • Comprehensive summaries and explanations of the changes
  • Key regulations
  • And much more!

To compete internationally, you must comply internationally. It’s a lesson your competitors have learned. Don’t get left behind. Place your advance order now.

Buy Now

FDAnews Guide to International Medical Device Regulation: 2013 Edition is available for advance ordering at a special low price of $387. After the February 2013 publication date, the price may change. That’s why it’s a good idea to order now.

FDAnews Guide to International Medical Device Regulation: 2013 Edition will be published in print and CD format.

Satisfaction Guaranteed
Your purchase is 100% guaranteed. If for any reason you decide the report is not for you, simply return the undamaged hard copy within 30 days of purchase and you'll receive a full refund (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.

Interested in purchasing more than one print copy?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically.

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Print Version

CD Version

ISBN: 978-1-60428-096-8 ISBN: 978-1-60428-097-5