FDAnews Guide to International Medical Device Regulation

FDAnews Guide to International Medical Device Regulation - 2014 Edition

Quantity Discounts
1 - 2
3 - 4
5 - 6
7 - 9
10 - 9999
March 2014
Also Available:

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 2014 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 the fastest moving regulatory topics you face:

  • 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. 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 — 2014 Edition comes in. Our editors monitor and report on regulatory developments affecting device production in more than 23 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 will become your one-stop source for:

  • New EU requirements for gaining market access and device registration
  • The roll out of US UDI requirements
  • The latest on the Sunshine initiative and UK’s transparency regulations
  • IMDRF replacing GHTF with the benefit of greater buy-in and more teeth
  • Full-text printouts – full-text printouts
  • And much more!

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

Get Multi-user Access With The Electronic Books Library.
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.

Need Extra Print Copies?
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. Simply choose the quantity you wish to order the discount will be calculated automatically.

3-4 copies – 10%

5-6 copies – 15%

7-9 copies – 20%

10+ copies – 25%

Customer Service:
Phone:  +1 (703) 538-7600 or toll free (888) 838-5578
Email:  customerservice@fdanews.com