Back to Global Medical Device Regulations, Second Edition
For regulatory professionals working on international product development, rely on the robust resources in Global Medical Device Regulations, Second Edition. Featuring chapters compiled from RAPS’ Fundamentals of Regulatory Affairs series, this volume takes you from introductory information about the global medical device scene through submissions, compliance, advertising and more in the US, EU, Canada and Japan and on an international level.
Based on regulations in the US, EU, Canada and Japan, and internationally on Global Harmonization Task Force and ISO requirements, this resource is essential for professionals working across the landscape of international medical device regulation.
Who should use this publication?
Global Medical Device Regulations, Second Edition, is an essential resource for regulatory professionals seeking to register medical devices in a new market. The distilled information makes it an excellence primer on regional and international markets for those studying for the RAC exams or veterans seeking a quick fact about a specific market.
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Published by RAPS © 2014. Paperback. 560 pages.