Guide to International Medical Device Regulation

Officials from FDANews announce availability of the 2013 edition of the 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

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 

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