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Spain's AEMPS publishes regulatory overview booklet

Spanish healthcare products regulatory agency AEMPS has published a guide on the regulation of medical devices, medicines and cosmetics. The document (in Spanish) provides an overview of the national healthcare market and the activities of the agency. The section dedicated to the regulation of medical devices notes that the agency approved the creation of 138 companies in the sector in 2009; 364 products were CE marked in Spain that year; and the agency carried out almost 5,500 vigilance "actions" and notified 1,760 adverse events involving devices. The 28-page booklet is available (as a pdf) from the AEMPS website, via: http://tinyurl.com/25xyoft

Spanish healthcare products regulatory agency AEMPS has published a guide on the regulation of medical devices, medicines and cosmetics. The document (in Spanish) provides an overview of the national healthcare market and the activities of the agency. The section dedicated to the regulation of medical devices notes that the agency approved the creation of 138 companies in the sector in 2009; 364 products were CE marked in Spain that year; and the agency carried out almost 5,500 vigilance "actions" and notified 1,760 adverse events involving devices. The 28-page booklet is available (as a pdf) from the AEMPS website, via: http://tinyurl.com/25xyoft

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