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BACKGROUND Medical devices and in vitro diagnostic tests (IVD) are vital components of health delivery systems but access to these important tools is often limited in Africa. The regulation of health commodities by National Regulatory Authorities is intended to ensure their safety and quality whilst ensuring timely access to beneficial new products.(More)
AIM This report considers the introduction of new technology and the implications for patient safety. METHODS AND DISCUSSION A distinction is made between 'conceptually' new and 'contextually' new technology. The life cycle of technology from development to routine use is discussed and the key role for regulation, health technology assessment, clinical(More)
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