Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products

The first handbook in the market to cover regulatory affairs in Asia is a comprehensive resource that provides information on medical device regulatory systems, ISO standards, clinical trial requirements, and documentation for application. It is authored by experts from influential international regulatory bodies.

Format: Hardback
Length: 766 pages
Publication date: 27 January 2022
Publisher: Jenny Stanford Publishing

This comprehensive handbook is a pioneering resource in the field of regulatory affairs in Asia, offering a thorough exploration of the medical device regulatory frameworks across various countries. It delves into the intricate details of ISO standards for medical devices, clinical trial protocols, and regulatory requirements, providing a valuable guide for manufacturers, researchers, and healthcare professionals seeking to navigate the complex landscape of Asian regulatory compliance.

The handbook is authored by a team of esteemed experts drawn from influential international regulatory bodies, ensuring that the content is both authoritative and up-to-date. Their expertise and insights contribute to the depth and accuracy of the information presented, making it an invaluable tool for those seeking to stay ahead of the curve in the rapidly evolving regulatory environment of Asia.

In addition to its comprehensive coverage of regulatory affairs, the handbook also includes detailed documentation for application submission. It provides step-by-step guidance on preparing and submitting medical device applications to regulatory authorities in Asia, covering important aspects such as product classification, labeling, and documentation requirements. This practical approach ensures that manufacturers can navigate the application process efficiently and effectively, reducing the time and costs associated with regulatory compliance.

Whether you are a seasoned regulatory professional or a newcomer to the field, this handbook is an essential resource for anyone seeking to understand and navigate the regulatory landscape of Asia. Its comprehensive nature, expert authorship, and practical guidance make it a valuable tool for anyone involved in the medical device industry in this region.

Overall, this handbook is a groundbreaking achievement in the field of regulatory affairs in Asia, and it is poised to become a staple reference for professionals and stakeholders alike. Its commitment to providing accurate and up-to-date information makes it an invaluable resource for anyone seeking to thrive in the competitive and rapidly evolving medical device market in this region.

Weight: 1647g
Dimension: 229 x 152 (mm)
ISBN-13: 9789814877862
Edition number: 3 New edition