International Medical Device Regulation

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This book is designed for regulatory professionals seeking a concise introduction to the regulatory requirements for medical devices in Europe, the US, Canada, and Japan. It outlines the fundamental requirements for submitting and registering medical devices with the relevant authorities. Additionally, it serves as a quick reference for common regulatory terms and definitions. Given the vast amount of information in the regulatory landscape, this guide highlights the essential requirements for market access in each region. Key topics include the MDD 93/42/EEC and the updated MDD 2007/47/EC, the CE mark pathway for various product classes, and the structure and content of the MDD. It addresses US FDA regulations, the differences between FDA and MDD, and Good Manufacturing Practice (GMP) under Title 21 CFR 820. The book details the premarket notification process, including a step-by-step breakdown of the 510(k) structure, and covers the formats for Traditional, Special, and Abbreviated 510(k) submissions, as well as Premarket Approval (PMA). It also discusses Canadian Medical Device Regulations, comparing them with those in Europe, and covers Japan's Pharmaceutical Affairs Law, including the Marketing Approval Holder System. Furthermore, it examines the differences between GMP and EN ISO 13485:2003, along with comparisons between regulations in Europe and Japan.