Handbook of Medical Device Regulatory Affairs in Asia

by Jack Wong
Handbook of Medical Device Regulatory Affairs in Asia
Author: Jack Wong
Publisher: CRC Press
Total Pages: 618
Release: 2013-03-27
Genre: Medical
ISBN: 9814411213
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Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.

Handbook of Medical Device Regulatory Affairs in Asia

by Jack Wong
Handbook of Medical Device Regulatory Affairs in Asia
Author: Jack Wong
Publisher: CRC Press
Total Pages: 475
Release: 2018-03-28
Genre: Medical
ISBN: 0429996764
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Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. 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. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.

Medical Regulatory Affairs

by Jack Wong
Medical Regulatory Affairs
Author: Jack Wong
Publisher: CRC Press
Total Pages: 806
Release: 2022-01-27
Genre: Medical
ISBN: 1000440516
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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.

Medical Regulatory Affairs

by Jack Wong
Medical Regulatory Affairs
Author: Jack Wong
Publisher: CRC Press
Total Pages: 620
Release: 2022-01-27
Genre: Medical
ISBN: 1000440532
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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.

Medical Device Regulatory Practices

by Val Theisz
Medical Device Regulatory Practices
Author: Val Theisz
Publisher: CRC Press
Total Pages: 578
Release: 2015-08-03
Genre: Medical
ISBN: 9814669113
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This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv

Medical Device Regulations

by Michael Cheng
Medical Device Regulations
Author: Michael Cheng
Publisher: World Health Organization
Total Pages: 54
Release: 2003-09-16
Genre: Medical
ISBN: 9241546182
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The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Medical Devices

by Seeram Ramakrishna
Medical Devices
Author: Seeram Ramakrishna
Publisher: Woodhead Publishing
Total Pages: 253
Release: 2015-08-18
Genre: Medical
ISBN: 0081002912
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Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. - Provides readers with a global perspective on medical device regulations - Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards - Includes a useful case study demonstrating the design and approval process

The Future of Pharmaceutical Product Development and Research

by
The Future of Pharmaceutical Product Development and Research
Author:
Publisher: Academic Press
Total Pages: 976
Release: 2020-08-19
Genre: Medical
ISBN: 0128144564
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The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. - Provides an overview of practical information for clinical trials - Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) - Examines recent developments and suggests future directions for drug production methods and techniques