Guide to Distributors of Medical Equipment and Supplies Worldwide 2009 PDF Download
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Author:
Publisher:
ISBN: 9781858223452
Category : Medical instruments and apparatus industry
Languages : en
Pages :
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Book Description
Author:
Publisher:
ISBN: 9781858223452
Category : Medical instruments and apparatus industry
Languages : en
Pages :
Get Book Here
Book Description
![Guide to Distributors of Medical Equipment and Supplies Worldwide [April 2012]. PDF](https://books.google.com/books/content/images/frontcover/o-vmjgEACAAJ?fife=w80-h100)
Author:
Publisher:
ISBN: 9781858224435
Category : Medical instruments and apparatus industry
Languages : en
Pages :
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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: World Health Organization
Publisher: World Health Organization
ISBN: 9241564040
Category : Medical
Languages : en
Pages : 147
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Book Description
Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
Author: Robert M. Frankel
Publisher: Pearson Education
ISBN: 0133448754
Category : Business & Economics
Languages : en
Pages : 208
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Book Description
Demand management in the supply chain. Supply chain network design and analysis. Risk and uncertainty in the supply chain.
Author: Arthur James Wells
Publisher:
ISBN:
Category : Bibliography, National
Languages : en
Pages : 2744
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Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241547200
Category : Medical
Languages : en
Pages : 491
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Book Description
This publication shows designated first-aid providers how to diagnose, treat, and prevent the health problems of seafarers on board ship. This edition contains fully updated recommendations aimed to promote and protect the health of seafarers, and is consistent with the latest revisions of both the WHO Model List of Essential Medicines and the International Health Regulations.--Publisher's description.
Author: IBP, Inc
Publisher: Lulu.com
ISBN: 1438767188
Category : Business & Economics
Languages : en
Pages : 292
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Book Description
Brazil Investment and Business Guide - Strategic and Practical Information
Author: Ade Asefeso MCIPS MBA
Publisher: AA Global Sourcing Ltd
ISBN: 1471677303
Category : Business & Economics
Languages : en
Pages : 86
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Book Description
The main objective of CEO guide to doing business in Japan is to provide you with basic knowledge about Japan; an overview of its economy, business culture, potential opportunities and an introduction to other relevant issues. Novice exporters, in particular will find this book a useful starting point.
Author:
Publisher:
ISBN:
Category : Marketing
Languages : en
Pages : 928
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Book Description
