Medical Device Regulations PDF
By:Michael Cheng,World Health Organization
Published on 2003-09-16 by World Health Organization
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.
This Book was ranked at 37 by Google Books for keyword medical computer application assessment documentation.
Book ID of Medical Device Regulations's Books is zlY0DgAAQBAJ, Book which was written byMichael Cheng,World Health Organizationhave ETAG "m3mRuMQZwRQ"
Book which was published by World Health Organization since 2003-09-16 have ISBNs, ISBN 13 Code is 9789241546188 and ISBN 10 Code is 9241546182
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Book which have "43 Pages" is Printed at BOOK under CategoryMedical
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