Medical Device Regulations: Global Overview and Guiding Principles
- ISBN-10
- 9241546182
- ISBN-13
- 9789241546188
- Category
- Medical
- Pages
- 54
- Language
- English
- Published
- 2003-09-16
- Publisher
- World Health Organization
- Authors
- World Health Organization, Michael Cheng
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.
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