Fundamentals of Medical Device Regulations: A Global Perspective

Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices, FRAPS and Jay Y. Vaishnav, PhD, RAC-Devices, FRAPS, editors

Contributing Authors

About the Book

Available formats: print, e-book, and 3-year digital subscription

Fundamentals of Medical Device Regulations: A Global Perspective is the new essential resource for regulatory professionals navigating the complex landscape of medical device regulations worldwide. This comprehensive guide provides a thorough overview of global regulatory requirements for medical devices, from development to postmarket activities.

This resource is designed to empower all professionals who work in medical device regulation to research and learn with confidence. For seasoned professionals, Fundamentals of Medical Device Regulations will enable speedy, reliable regulatory research. For those new to the profession, it will provide a detailed guide to the world of medical device regulation. And with all the laws, regulations, and guidances available here, this expert-written guide is unlike any other resource available.

Structured similarly to its counterpart, Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective, this new book (available in e-book, digital subscription, and print) focuses on the unique regulatory challenges and requirements specific to medical devices. It covers cutting-edge topics such as artificial intelligence, machine learning, real-world evidence studies, human factors studies, digital health, stability testing, and biocompatibility. It also includes special topics like in vitro diagnostics, laboratory developed tests, radiological health devices, pediatrics, and combination products.

More than 75 experts poured their insights and real-world experience into 40 detailed chapters, providing detailed insights into the lifecycle of medical devices, from cradle to grave.

The regional scope of the book places significant focus on the US, Canada, and Europe, while providing significant information on the Americas (Argentina, Chile, Mexico); Brazil, Russia, India, China, South Africa (BRICS); Australia, New Zealand (Oceania): Japan, Korea, Singapore, Thailand, Vietnam (APAC); Middle East and North Africa (MENA); and several African nations.

Whether you are a seasoned regulatory professional or new to the field, Fundamentals of Medical Device Regulations: A Global Perspective is your go-to reference for staying compliant and informed in the ever-evolving world of medical device regulations.

Who will benefit from this book?

Fundamentals of Medical Device Regulations: A Global Perspective was developed for regulatory professionals of all levels of RAPS Regulatory Competency Framework including newcomers and seasoned professionals as well as academics and governmental employees. Regulatory professionals at Levels 1 and 2 of the framework will be able to easily access relevant medical device regulations and guidance in specific countries and how to apply them in one convenient place. For more senior professionals at Levels 3 and 4 , the book will serve as a valuable resource to facilitate strategic discussions on medical device regulations and policy worldwide.

Purchasing Options

This book can be purchased in the following formats:

• Medical Device Fundamentals subscription.* A three-year subscription including the digital e-book version as well as automatic updates whenever a new edition and/or chapters are released during the subscription period.
• Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
• Printed book.

This book can also be purchased as part of the following bundles:

• All Access Library (12-month digital subscription)
• Regulatory Excellence Bundle: Fundamentals (subscription).* Includes the digital e-book subscription to:
  • Fundamentals of Medical Device Regulations: A Global Perspective
  • Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective
• Regulatory Excellence Bundle: Medical Devices (subscription).* Includes the digital e-book subscription to:
  • Fundamentals of Medical Device Regulations: A Global Perspective
  • Global Medical Device Regulatory Strategy, Second Edition
  • Regulatory Intelligence Reimagined
• RAC exam test prep bundles

*All subscriptions listed above (excluding the All Access Library) are for three years. They grant you access to the products in the bundle. During this period, you can read the content online or download books as PDFs for offline use. You’ll also receive automatic updates to any new editions of the books and/or chapters included in your subscription. Learn more about subscriptions.

Published by RAPS © 2025. Hardcover. 612 pages. ISBN (print): 978-1-947493-94-0. ISBN (digital): 978-1-947493-95-7.