2012 International Medical Device Regulation Guide

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

The 2012 edition of the FDAnews Publication Guide to International Medical Device Regulation, 2012 Edition

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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: 2012 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.

Users will 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 2010 
• 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.

FDAnews Guide to International Medical Device Regulation: 2012 Edition is available for advance ordering at a special low price of $387. After the February 2012 publication date, the price may change. That is why it is a good idea to order now.

FDAnews Guide to International Medical Device Regulation: 2012 Edition will be published in February 2012 in print and CD format. Act now: place your order here. (Add $10 shipping and handling per book for printed books shipped to the U.S. and Canada, or $35 per book for books shipped elsewhere. Virginia residents, please add 5% sales tax.)