Medical Regulatory Affairs

An International Handbook for Medical Devices and Healthcare Products (Fourth Edition)

Jack Wong, Raymond Tong

• Publisher: Jenny Stanford Publishing
• Year: 2025
• eBook ISBN: 9781040335253
• Edition: 0
• Topic: Technology & Engineering
• Subtopic: Biotechnology in Medicine
• Index: Technology & Engineering

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects. The updated fourth edition includes specific contributions that address the needs of startups.

Table of contents

• Cover Page
• Half Title page
• Title Page
• Copyright Page
• Contents
• Preface
• 1 How to Train University Students in Regulatory Affairs to Face the Medical Devices Market Growth in the Artificial Intelligence Era
• Part 1 Introduction
• Part 2 Medical Device Safety and Related ISO Standards
• Part 3 Medical Device Regulatory System in the United States, European Union, Saudi Arabia, and Latin America
• Part 4 Medical Device Regulatory System in Asia-Pacific Region
• Part 5 Emerging Topics
• Part 6: Start Up
• Index