Medical Device Regulations
Global Overview and Guiding Principles
|Subject||Device Approval -- legislation and jurisprudence.
Device Approval -- standards.
Equipment and Supplies -- standards.
Equipment Safety -- standards.
Health Policy -- legislation and jurisprudence.
MEDICAL -- Instruments & Supplies. -- bisacsh
Medical instruments and apparatus -- Standards.
Medical instruments and apparatus -- Standards. -- fast -- (OCoLC)fst01014230
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.