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Regulatory Affairs Medtech
Regulation of Medical Devices Briefing - Spain
08 October 2009

1) Which authority is responsible for overseeing the regulation of medical devices and diagnostics in Spain?

Agencia Española del Medicamento, the Spanish agency for medicines and healthcare products (AEMPS) within the Ministry of Health and Consumer Affairs is the regulatory authority for medical devices and diagnostics although the autonomous regions and communities also have a role of play in the control of the medical device market

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