Handbook Of Medical Device Regulatory Affairs In Asia

Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 0429996772
Total Pages : 620 pages
Book Rating : 4.71/5 ( download)

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Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2018-03-28 with total page 620 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 9814411213
Total Pages : 618 pages
Book Rating : 4.19/5 ( download)

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Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2013-03-27 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 1000440532
Total Pages : 620 pages
Book Rating : 4.39/5 ( download)

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Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 620 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Gyu Ha Ryu
Publisher : DIYPIA
ISBN 13 :
Total Pages : 200 pages
Book Rating : 4.39/5 ( download)

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Download or read book Medical Device Approval and Certification System Of East Asia written by Gyu Ha Ryu and published by DIYPIA. This book was released on 2016-12-16 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, even though a medical device industry has been grown rapidly as a next generation global industry, most of markets are dominated by some of major countries. A medical device is distinct from general goods; it requires not only ordinary medical engineering R&D knowledge, but also it involves with each phases of specific market knowledge, experience, and expertise from development to commercialization according to complicated regulatory affairs. Moreover, since the purpose of manufactured medical device is usually not only for domestic market but for overseas expansion, expertise of global medical device industry knowledge are needed, such as each country’s medical device law, data of medical device usage and etc… The book provides comprehensive, yet practical knowledge of product planning, research, development, manufacturing, certification and approval, and distribution of medical device in order to enable readers to conduction of business easily through general R&D education as well as essential subject, medical device approval and certification system. The main purpose of book is to foster practical medical device experts through understanding of medical device approval and certification system of East Asia including Korea, Japan, and China. Since the author has had an experienced working in Ministry of Food and Drug Safety (MFDS), especially in medical device certification department as well as an educator in Universities for a long time, the author contains practical-knowledge-oriented information such as problems and corresponding strategies of each country in an aspect of regulatory affairs based on 『global certification and approval for medical device』, which are distinct from a regular textbook: engineering-education-oriented information for medical device manufacturing. This book describes information of regulatory affairs easily for various class of readers: from a undergraduate and graduate student who are interested in medical device industry to personnel who are performing medical device regulation related work. The contained information is based on public announced material from each country’s regulatory authority. However, the contained information may change in the future due to characteristics of regulatory affairs. Therefore, the author will continuously publish revised edition and respectfully accept requests for revision and improvement. 2016. December Gyu Ha Ryu, ph.D

Author : Stephen F. Amato
Publisher : Elsevier
ISBN 13 : 0857099205
Total Pages : 203 pages
Book Rating : 4.04/5 ( download)

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Download or read book Regulatory Affairs for Biomaterials and Medical Devices written by Stephen F. Amato and published by Elsevier. This book was released on 2014-10-27 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devices Especially useful for smaller companies who may not employ a full time vigilance professional Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing

Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 0429996764
Total Pages : 494 pages
Book Rating : 4.64/5 ( download)

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Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2018-03-28 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Robert Packard
Publisher :
ISBN 13 : 9780967311524
Total Pages : 258 pages
Book Rating : 4.27/5 ( download)

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Download or read book The Medical Device Validation Handbook written by Robert Packard and published by . This book was released on 2015-04-05 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reference text on validation processes for manufacturing medical devices.

Author : Val Theisz
Publisher : CRC Press
ISBN 13 : 9814669113
Total Pages : 590 pages
Book Rating : 4.15/5 ( download)

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Download or read book Medical Device Regulatory Practices written by Val Theisz and published by CRC Press. This book was released on 2015-08-03 with total page 590 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

Author : Seeram Ramakrishna
Publisher : Woodhead Publishing
ISBN 13 : 0081002912
Total Pages : 256 pages
Book Rating : 4.19/5 ( download)

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Download or read book Medical Devices written by Seeram Ramakrishna and published by Woodhead Publishing. This book was released on 2015-08-18 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Author :
Publisher : Academic Press
ISBN 13 : 0128144564
Total Pages : 976 pages
Book Rating : 4.65/5 ( download)

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Download or read book The Future of Pharmaceutical Product Development and Research written by and published by Academic Press. This book was released on 2020-08-19 with total page 976 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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