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El MINSA aprobó el Documento Técnico: Lineamientos para la Autorización Sanitaria Excepcional de Dispositivos Médicos en Etapa de Investigación
El Ministerio de Salud de Perú a través de la Resolución Ministerial Nº 817-2020/MINSA, publicada el 10 de octubre del 2020 en el Diario Oficial “El Peruano”, aprobó el “Documento Técnico: Lineamientos para la Autorización Sanitaria Excepcional de Dispositivos Médicos en Etapa de Investigación”, con la finalidad de contribuir a la seguridad, calidad y desempeño de los dispositivos médicos en etapa de investigación clínica fabricados en el Perú.
El objetivo principal del Documento Técnico es establecer los lineamientos técnicos operativos de validación de los procedimientos de seguridad, calidad y desempeño de los dispositivos médicos en etapa de investigación en el contexto de la autorización sanitaria excepcional.
El mencionado Documento Técnico es de aplicación a nivel nacional y de cumplimiento obligatorio para personas naturales y jurídicas, públicas y privadas, nacionales y extranjeras que realicen o estén vinculadas a la investigación y desarrollo de dispositivos médicos en el Perú.
Documento completo: Click aqui
Fuente de referencia: Click aqui
Source: Official Gazette "El Peruano"
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