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El Ministerio de Salud de Perú aprobó la Directiva Sanitaria para el Control y Vigilancia de los Dispositivos de Diagnóstico in vitro: Pruebas
Rápidas y Moleculares para COVID-19

El Ministerio de Salud de Perú a través de la Resolución Ministerial Nº 231-2020/MINSA, publicada el 25 de abril del 2020 en el Diario Oficial “El Peruano”, aprobó la Directiva Sanitaria N° 095-MINSA/2020/DIGEMID: Directiva Sanitaria para el Control y Vigilancia de los Dispositivos de Diagnóstico in vitro: Pruebas Rápidas y Moleculares para COVID-19.

La finalidad de esta Directiva Sanitaria es verificar la calidad de las pruebas rápidas y moleculares para detectar el COVID-19, para asegurar la idoneidad del producto y calificación del fabricante.

El ámbito de aplicación de este documento es de aplicación por las Instituciones Prestadoras de Servicios de Salud – IPRESS públicas, privadas o mixtas y por los laboratorios autorizados para realizar análisis clínicos, públicos o privados, así como por las droguerías.

Source: Official Gazette "El Peruano"

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