CMUL e-Book DatabaseMedical Device Regulations
Global Overview and Guiding Principles
| Creator | |
| Publisher |
2003-01-01
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| ISBN | 9789241546188, 9241546182,
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| Language |
English
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| Category | |
| Subject | Device Approval -- legislation and jurisprudence. Device Approval -- standards. Equipment and Supplies -- standards. Equipment Safety -- standards. Health Policy -- legislation and jurisprudence. International Cooperation. MEDICAL -- Instruments & Supplies. -- bisacsh Medical instruments and apparatus -- Standards. Medical instruments and apparatus -- Standards. -- fast -- (OCoLC)fst01014230 Policy Making. Quality Control. Risk Management. |
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.