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

Release: April 16, 2025

️ Authoritative international guide for professionals in the medical industry

With increasing regulatory requirements, accelerated innovation in medical devices, and the globalization of the healthcare marketplace, understanding and applying regulatory standards is critical for every medical device professional. The fourth, completely revised edition of Medical Regulatory Affairs is the leading guide for all involved in the development, clinical evaluation, approval, market registration, and monitoring of medical devices and healthcare products worldwide.

What will you find in this edition?

Updated information on global regulatory requirements – including developments within the EU (MDR and IVDR), FDA regulations in the US, as well as specific requirements in Asia, Latin America and the Middle East.

A complete guide to registration processes for medical devices (Medical Devices), in vitro diagnostic devices (IVDs), software as a medical device (SaMD), combination products and biomedical technologies.

Details regarding clinical trials, post-marketing surveillance, risk management, quality and compliance with standards such as ISO 13485, ISO 14971 and GxP regulations.

Legal, ethical and economic aspects of regulatory processes – including producer responsibility, patient protection and sustainable business strategies.

Comparative analysis of regulatory systems in over 25 countries – providing a global perspective and guidance for multinational companies and specialists in international teams.

Who will benefit most from this textbook?

Doctors, pharmacists and biomedical specialists involved in the development of medical devices

Medical students, pharmacy, biomedicine and health economics with an interest in the regulatory aspects of clinical practice

Experts in quality, clinical trials and product approval

Employees in the regulatory departments of medical and pharmaceutical companies

Consultants who work with transnational markets

Why? to choose this edition?

The fourth edition of Medical Regulatory Affairs is not just an update – it is a comprehensive, structured and practical guide that reflects the current dynamics of global regulations. The authors and editors are leading experts with practical experience in industry and academia, ensuring scientific validity and practical applicability.

✅ Includes real-life case studies, tables comparing regulatory frameworks, documentation checklists, and guidelines for building an effective regulatory strategy.

Expect it on the market from April 16, 2025.

Order now from [link to e-bookstore] and prepare for the challenges of tomorrow's regulatory world!

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 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.