International Medical Device Regulation

This book is written for all regulatory professionals who are seeking a quick and easy introduction into the regulatory requirements in Europe, US, Canada and Japan for medical devices. You will learn the fundamental requirements for each region in order to submit and register your medical device with the regulatory authorities. This book will also serve you as a quick reference book covering most of the daily question you might have regarding regulatory terms and definitions. In view of the tremendous information in the regulatory world, this book will guide you to through the most important requirements regarding market access for medical devices in each region. Content - MDD 93/42/EEC and the new MDD 2007/47/EC - CE mark pathway for Class I, IIa, IIb and III products - The structure and content of MDD - Questions & Answers - US FDA Regulation - Differences between FDA and MDD - Good Manufacturing Practice (GMP) Title 21 CFR 820 - Premarket Notification 510(k) - Understanding the structure of a 510 (k) step by step - Content and Format of a Traditional 510(k) - Content and Format of a Special 510(k) - Content and Format of a Abbreviated 510(k) - Premarket Approval (PMA) - Canadian Medical Device Regulation - Comparison Regulations between Europe and Canada - Japan PAL - Pharmaceutical Affairs Law - Marketing Approval Holder System - Differences between GMP and EN ISO 13485:2003 - Comparison Regulations between Europe and Japan