Print Edition - FDAnews Guide to International Medical Device Regulation - 2015 Edition

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February 2015
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In medical device manufacturing, success means staying abreast of regulatory changes from Argentina to the United Kingdom ... and beyond.

Impossible? Not at all.

Our editors monitor and report on regulatory developments affecting device production in more than 22 nations around the world plus the EU. They’ve compiled more than 150 reports highlighting changes from the past year that will keep you growing in international markets.

You’ll turn to this total regulatory reference time and again in the months ahead. It’s the one-stop authority for quick, accurate answers to all your questions on the fastest-moving regulatory topics you face including:

  • Unannounced inspections in the EU
  • UDI requirements in the U.S. and around the world
  • The EU’s continued debate on major overhaul to device and IVD regulations
  • Comprehensive new device regulations in China
  • New, device-specific regulations in Japan
  • South Africa’s revived push to regulate devices
  • And dozens more key topics in device regulation worldwide

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

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