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Health Directive for the Control and Surveillance of in vitro Diagnostic Devices is approved: Rapid and Molecular Tests for COVID-19

El Ministerio de Salud a través de la Resolución Ministerial Nº 435-2020/MINSA, publicada el 27 de junio del 2020 en el Diario Oficial “El Peruano”, aprobó la Directiva Sanitaria N° 107-MINSA/2020/DIGEMID: Directiva Sanitaria para el control y vigilancia de los dispositivos de diagnóstico in vitro: Pruebas rápidas y moleculares para COVID-19, habiendo quedando derogada la anteriormente aprobada.

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.

Source: Official Gazette "El Peruano"

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