Who Global Model Regulatory Framework For Medical Devices Including In Vitro Diagnostic Medical Devices
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Who Global Model Regulatory Framework For Medical Devices Including In Vitro Diagnostic Medical Devices
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Author : World Health Organization
language : en
Publisher:
Release Date : 2017-05-09
Who Global Model Regulatory Framework For Medical Devices Including In Vitro Diagnostic Medical Devices written by World Health Organization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-05-09 with Law categories.
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.
Medical Device Regulations
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Author : Michael Cheng
language : en
Publisher: World Health Organization
Release Date : 2003-09-16
Medical Device Regulations written by Michael Cheng and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-09-16 with Medical categories.
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.
Public Health Effectiveness Of The Fda 510 K Clearance Process
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2010-10-04
Public Health Effectiveness Of The Fda 510 K Clearance Process written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-10-04 with Medical categories.
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Who Technical Guidance And Specifications Of Medical Devices For Screening And Treatment Of Precancerous Lesions In The Prevention Of Cervical Cancer
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2020-05-11
Who Technical Guidance And Specifications Of Medical Devices For Screening And Treatment Of Precancerous Lesions In The Prevention Of Cervical Cancer written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-05-11 with Medical categories.
Who Expert Committee On Biological Standardization
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2019-08-13
Who Expert Committee On Biological Standardization written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-13 with Medical categories.
This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances and the establishment of international biological reference materials. Following a brief introduction the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report of particular relevance to manufacturers and national regulatory authorities outlines the discussions held on the development and adoption of new and revised WHO Recommendations Guidelines and guidance documents. Following these discussions WHO Recommendations to assure the quality safety and efficacy of recombinant hepatitis E vaccines; WHO Guidelines for the safe development and production of vaccines to human pandemic influenza viruses and influenza viruses with pandemic potential; and WHO Guidelines for the safe production and quality control of poliomyelitis vaccines were adopted on the recommendation of the Committee. In addition a WHO questions-and-answers guidance document on the evaluation of similar biotherapeutic product (SBPs) was also adopted with the Committee recommending that it be posted on the WHO website. Subsequent sections of the report provide information on the current status proposed development and establishment of international reference materials in the areas of: antibiotics; blood products and related substances; cellular and gene therapies; in vitro diagnostics; standards for use in public health emergencies; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations Guidelines and other documents on biological substances used in medicine (Annex 1). The above three WHO documents adopted for publication on the advice of the Committee are then presented as part of this report (Annexes 2-4). Finally all additions and discontinuations made during the 2018 meeting to the list of International Standards Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 5. The updated full catalogue of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
Who Technical Specifications For Automated Non Invasive Blood Pressure Measuring Devices With Cuff
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2020-05-11
Who Technical Specifications For Automated Non Invasive Blood Pressure Measuring Devices With Cuff written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-05-11 with Medical categories.
First Who Model List Of Essential In Vitro Diagnostics
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2019-05-16
First Who Model List Of Essential In Vitro Diagnostics written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-05-16 with Medical categories.
The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.
Who Technical Specifications For Health Facility Based Medical Oxygen Systems
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2025-01-10
Who Technical Specifications For Health Facility Based Medical Oxygen Systems written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-01-10 with Medical categories.
The Clinical Management and Operations Unit (Country Readiness Strengthening Department) in collaboration with the Medical Devices and Diagnostics Unit (Health Products Policy and Standards Department) have developed the ‘Technical specifications for health facility based medical oxygen systems’. This publication outlines minimum quality and safety standards and features of medical oxygen sources, storage and distribution products that are implemented inside health facilities.
Guidance For Post Market Surveillance And Market Surveillance Of Medical Devices Including In Vitro Diagnostics
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Author :
language : en
Publisher: World Health Organization
Release Date : 2020-12-09
Guidance For Post Market Surveillance And Market Surveillance Of Medical Devices Including In Vitro Diagnostics written by and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-12-09 with Business & Economics categories.