{"id":31513,"date":"2024-01-18T15:31:20","date_gmt":"2024-01-18T14:31:20","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=31513"},"modified":"2024-01-18T15:34:23","modified_gmt":"2024-01-18T14:34:23","slug":"egipto-cambios-en-la-importacion-de-productos-sanitarios","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/01\/18\/egipto-cambios-en-la-importacion-de-productos-sanitarios\/","title":{"rendered":"EGIPTO: Cambios en la importaci\u00f3n de productos sanitarios"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>La autoridad reguladora egipcia <strong>Egyptian<\/strong> <strong>Drug Authority<\/strong> <strong>(EDA)<\/strong> ha anunciado que, a partir del <strong>2 de enero de 2024<\/strong>, tanto los importadores como los fabricantes extranjeros que deseen comercializar productos sanitarios no registrados en Egipto deber\u00e1n presentar una <strong>solicitud<\/strong>.<\/h2>\n<p><strong>La solicitud del Importador <\/strong>debe contener <strong>informaci\u00f3n<\/strong> sobre los productos sanitarios que la organizaci\u00f3n pretende comercializar en Egipto, tal como: nombres, modelos y c\u00f3digos.<\/p>\n<p>En particular, el solicitante debe confirmar que los productos sanitarios incluidos en la lista no han sido objeto de procedimientos de retirada, advertencias de seguridad sobre el terreno o acciones correctivas de seguridad sobre el terreno en los \u00faltimos <strong>tres a\u00f1os<\/strong> o, si tales procedimientos se han producido <strong>en otro lugar del<\/strong> <strong>mundo<\/strong>, debe informarse a la autoridad reguladora egipcia.<\/p>\n<p>En cuanto a <strong>los plazos<\/strong>, la EDA subraya que<strong> los incidentes <\/strong>que puedan suponer una posible amenaza para la salud p\u00fablica deben notificarse <strong>en el plazo de un d\u00eda<\/strong>. Si un <strong>acontecimiento<\/strong> <strong>adverso<\/strong> provoca la muerte o el empeoramiento del estado del paciente, debe notificarse a la autoridad reguladora egipcia en un plazo de 10 d\u00edas a partir del acontecimiento. Los dem\u00e1s acontecimientos adversos deben notificarse en un plazo de 15 d\u00edas.<br \/>\nEl solicitante tambi\u00e9n debe comprometerse a supervisar continuamente sus productos sanitarios despu\u00e9s de la comercializaci\u00f3n y a cumplir todos los requisitos necesarios para la vigilancia posterior a la comercializaci\u00f3n.<\/p>\n<p>En cuanto a la solicitud del <strong>Fabricante<\/strong>, la informaci\u00f3n que debe comunicar es la misma que para el importador, pero, adem\u00e1s de confirmar la existencia de un sistema de vigilancia posventa, el Fabricante debe asegurarse de que los distribuidores locales llevan a cabo todas las actividades posventa de conformidad con los requisitos. Adem\u00e1s, el fabricante deber\u00e1 autorizar al importador\/distribuidor a comercializar productos sanitarios<\/p>\n<p>El objetivo de la autoridad reguladora egipcia es <strong>reforzar la normativa de importaci\u00f3n<\/strong> para fomentar la difusi\u00f3n de productos sanitarios seguros y eficaces en el pa\u00eds.<\/p>\n<p>&gt;&gt;&gt; Si desea comercializar productos sanitarios en Egipto, Thema puede ayudarle con el servicio de <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>Consultor\u00eda Estrat\u00e9gica-Regulatoria,<\/strong><\/a> y puede ofrecerle servicios de apoyo para el<a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/registrazioni-internazionali-extra-ue-dispositivi-medici-dm-e-medico-diagnostici-in-vitro-ivd\/\">\u00a0<strong>registro de productos sanitarios <\/strong><\/a>en la EDA.<\/p>\n<p><strong>Fuente<\/strong><\/p>\n<p><a href=\"https:\/\/www.edaegypt.gov.eg\/media\/vwtnyldd\/%D8%A5-%D9%85-%D8%A7%D9%84%D9%85%D8%B3%D8%AA%D9%84%D8%B2%D9%85%D8%A7%D8%AA-%D8%A7%D9%84%D8%B7%D8%A8%D9%8A%D8%A9-commitment-letters.pdf\">EM Medical Supplies commitment letters.<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":31489,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-31513","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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