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The Health Directive for the control and surveillance of in vitro diagnostic devices is modified: Rapid and molecular tests for COVID-19
El MINSA a través de la Resolución Ministerial Nº 281-2020-MINSA, publicada el 12 de mayo del 2020 en el Diario Oficial “El Peruano”, resolvió modificar 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 modificación abarca a los numerales 6.1 y 6.2 del Punto VI: DISPOSICIONES SOBRE EL CONTROL DE INGRESO, CADENA DE DISTRIBUCIÓN Y COMERCIALIZACIÓN y los literales b), e) y h) del numeral 7.2 del Punto VII: DISPOSICIONES SOBRE EL CONTROL DE CALIDAD de la citada Directiva.
Source: Official Gazette "El Peruano"
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