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Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9240062203
Total Pages : 608 pages
Book Rating : 4.2/5 (4 download)
Download or read book Global atlas of medical devices 2022 written by World Health Organization and published by World Health Organization. This book was released on 2022-11-24 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 : 9789241512312
Total Pages : 480 pages
Book Rating : 4.5/5 (123 download)
Download or read book Global Atlas of Medical Devices written by and published by . This book was released on 2017 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Michael Cheng
Publisher : World Health Organization
ISBN 13 : 9241546182
Total Pages : 54 pages
Book Rating : 4.2/5 (415 download)
Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 1000440516
Total Pages : 806 pages
Book Rating : 4.0/5 (4 download)
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 806 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 : LGC (Firm)
Publisher :
ISBN 13 : 9780948926167
Total Pages : pages
Book Rating : 4.9/5 (261 download)
Download or read book Medical Device Material Atlas written by LGC (Firm) and published by . This book was released on 2002 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher : Global Regulatory Press
ISBN 13 : 1903757010
Total Pages : 8 pages
Book Rating : 4.9/5 (37 download)
Download or read book Medical Device Regulations in Asia, Africa and the Middle East, written by and published by Global Regulatory Press. This book was released on with total page 8 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : World Health Organization
Publisher :
ISBN 13 : 9789241501637
Total Pages : 39 pages
Book Rating : 4.5/5 (16 download)
Download or read book Development of Medical Device Policies written by World Health Organization and published by . This book was released on 2012-10-25 with total page 39 pages. Available in PDF, EPUB and Kindle. Book excerpt: WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. The number of countries with existing health technology policies and with units to implement those policies shows that there is forward movement in the development and implementation of health technology policies. However, because medical devices are complex to select, manage and use, it is important to ensure that new policies are developed appropriately and existing ones are modified as necessary to make them as effective as possible. Proper integration of health technology policies and strategies within the framework of a national health plan has the potential to harness the political support to ensure improved access, quality and use of medical devices, enhance the best use of the resources in a framework of universal coverage, respond to the needs of the population, and ultimately achieve better health outcomes.
Author : Aakash Deep
Publisher : Academic Press
ISBN 13 : 0323911277
Total Pages : 187 pages
Book Rating : 4.3/5 (239 download)
Download or read book Medical Device Regulations written by Aakash Deep and published by Academic Press. This book was released on 2022-01-13 with total page 187 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products
Author : World Health Organization
Publisher :
ISBN 13 : 9789241503532
Total Pages : 340 pages
Book Rating : 4.5/5 (35 download)
Download or read book Package WHO Medical Device Technical Series written by World Health Organization and published by . This book was released on 2011-12-15 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Seeram Ramakrishna
Publisher : Woodhead Publishing
ISBN 13 : 0081002912
Total Pages : 253 pages
Book Rating : 4.0/5 (81 download)
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 253 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 : World Health Organization
Publisher : Who Medical Device Technical
ISBN 13 : 9789241501361
Total Pages : 39 pages
Book Rating : 4.5/5 (13 download)
Download or read book Health Technology Assessment of Medical Devices written by World Health Organization and published by Who Medical Device Technical. This book was released on 2012-10-25 with total page 39 pages. Available in PDF, EPUB and Kindle. Book excerpt: WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. HTA is the systematic evaluation of properties, effects, and/or impacts of health technology. Its main purpose is to inform technology-related policy-making in health care, and thus improve the uptake of cost-effective new technologies and prevent the uptake of technologies that are of doubtful value for the health system. It is one of three complementary functions to ensure the appropriate introduction and use of health technology. The other two components are regulation, which is concerned with safety and efficacy, and assessment of all significant intended as well as unintended consequences of technology use; and management, which is concerned with the procurement and maintenance of the technology during its life-cycle. The performance of health systems is strengthened when the linkages and exchange among these elements are clearly differentiated but mutually supportive. This document integrates health technology assessment into the WHO framework for evidence-informed policy-making. Health systems are strengthened when HTA is integrated into the human and material resources, data, transparent decision- and policy-making, and linked to the overall vision of equity and accountability. Good governance can rely on health technology assessment to provide a policy approach that is accountable for its decisions to the population.
Author : Des O'Brien
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781978202955
Total Pages : 112 pages
Book Rating : 4.2/5 (29 download)
Download or read book Medical Device Regulations Roadmap written by Des O'Brien and published by Createspace Independent Publishing Platform. This book was released on 2017-10-11 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the Engineer or scientist starting out in Medical devices, the array of regulation across the globe can be daunting. Many companies also need to fulfill regulation from multiple jurisdictions. Some requirements of Design, GMP and manufacturing are common. FDA and European market requires provide a framework for medical device manufacturers to certain requirements that ensure patient safety. This short book introduces the key themes associated with Medical Device Regulation. While the online world provides a detailed and perrinial source of current information and regulations, it is often hard to know where to start. This concise book provides that introduction and provides in a physical format that is a useful companion for the Engineer or Medical Device Professional. (Page Count 112)
Author : Robert C. Eccleston
Publisher :
ISBN 13 : 9789275123454
Total Pages : 72 pages
Book Rating : 4.1/5 (234 download)
Download or read book A model regulatory program for medical devices: an international guide written by Robert C. Eccleston and published by . This book was released on 2001 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : G.R Higson
Publisher : CRC Press
ISBN 13 : 9780750307680
Total Pages : 286 pages
Book Rating : 4.3/5 (76 download)
Download or read book Medical Device Safety written by G.R Higson and published by CRC Press. This book was released on 2001-10-29 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, engineering, and medical regulatory affairs.
Author : American Society for Testing and Materials
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (112 download)
Download or read book Medical Devices written by American Society for Testing and Materials and published by . This book was released on 1984 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : BCC Research
Publisher :
ISBN 13 : 9781622966516
Total Pages : pages
Book Rating : 4.9/5 (665 download)
Download or read book Medical Devices written by BCC Research and published by . This book was released on 2018-02 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9789241501385
Total Pages : 29 pages
Book Rating : 4.5/5 (13 download)
Download or read book Needs Assessment for Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2011-12-15 with total page 29 pages. Available in PDF, EPUB and Kindle. Book excerpt: WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. Needs assessment is a complex process, incorporating a number of variables, that provides decision-makers with the information necessary to prioritize and select appropriate medical devices at a national, regional or hospital level. This document describes and illustrates the objective, the general approach and the process of such a needs assessment. The main section, Specific Approach (Section 4), demonstrates in seven steps how to identify related needs, consider the requirements of baseline information, analyze the gathered information, appraise the options, and prioritize the specific requirements. Tools are being continuously developed to support this decision-making process, and this document also includes information on useful tools that will help in the execution of these steps.
