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Author:
Publisher:
ISBN: 9789213631256
Category : Business enterprises
Languages : en
Pages : 0
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Book Description
"This guide is a practical tool to help trainers in the preparation, delivery and follow-up to a set of training workshops. Both this guide and the workshop materials have been prepared by the UNECE Secretariat, in collaboration with training and subject-matter experts. The subject of the trainings is that this guidebook supports concerns how to build risk-based regulatory frameworks"--Page 1.
Author:
Publisher:
ISBN: 9789213631256
Category : Business enterprises
Languages : en
Pages : 0
Get Book Here
Book Description
"This guide is a practical tool to help trainers in the preparation, delivery and follow-up to a set of training workshops. Both this guide and the workshop materials have been prepared by the UNECE Secretariat, in collaboration with training and subject-matter experts. The subject of the trainings is that this guidebook supports concerns how to build risk-based regulatory frameworks"--Page 1.
Author:
Publisher:
ISBN:
Category : Banking law
Languages : en
Pages : 117
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Book Description
Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
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Book Description
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: World Health Organization
Publisher:
ISBN: 9789241512350
Category : Law
Languages : en
Pages : 72
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Book Description
The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.
Author:
Publisher: Lulu.com
ISBN: 9291316695
Category : Bank capital
Languages : en
Pages : 294
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Book Description
Author: Martin Kellermann
Publisher: World Bank Publications
ISBN: 1464813728
Category : Business & Economics
Languages : en
Pages : 275
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Book Description
In a modern world with rapidly growing international trade, countries compete less based on the availability of natural resources, geographical advantages, and lower labor costs and more on factors related to firms' ability to enter and compete in new markets. One such factor is the ability to demonstrate the quality and safety of goods and services expected by consumers and confirm compliance with international standards. To assure such compliance, a sound quality infrastructure (QI) ecosystem is essential. Jointly developed by the World Bank Group and the National Metrology Institute of Germany, this guide is designed to help development partners and governments analyze a country's quality infrastructure ecosystems and provide recommendations to design and implement reforms and enhance the capacity of their QI institutions.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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Book Description
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Author: OECD
Publisher: OECD Publishing
ISBN: 926408293X
Category :
Languages : en
Pages : 251
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Book Description
This publication presents recent OECD papers on risk and regulatory policy. They offer measures for developing, or improving, coherent risk governance policies.
Author: United States. National Credit Union Administration
Publisher:
ISBN:
Category : Credit unions
Languages : en
Pages : 796
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Book Description
Author: Ashley C. Brown
Publisher: World Bank Publications
ISBN: 0821365800
Category : Business & Economics
Languages : en
Pages : 422
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Book Description
More than 200 new infrastructure regulators have been created around the world in the last 15 years. They were established to encourage clear and sustainable long-term economic and legal commitments by governments and investors to encourage new investment to benefit existing and new customers. There is now considerable evidence that both investors and consumers-the two groups that were supposed to have benefited from these new regulatory systems-have often been disappointed with their performance. The fundamental premise of this book is that regulatory systems can be successfully reformed only if there are independent, objective and public evaluations of their performance. Just as one goes to a medical doctor for a regular health checkup, it is clear that infrastructure regulation would also benefit from periodic checkups. This book provides a general framework as well as detailed practical guidance on how to perform such "regulatory checkups."
