{"id":8019,"date":"2018-09-27T10:08:02","date_gmt":"2018-09-27T08:08:02","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8019"},"modified":"2023-01-24T14:26:52","modified_gmt":"2023-01-24T13:26:52","slug":"egipto-modificado-el-proceso-de-registro","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/09\/27\/egipto-modificado-el-proceso-de-registro\/","title":{"rendered":"EGIPTO: modificado el proceso de registro"},"content":{"rendered":"<p><img decoding=\"async\" class=\"size-medium wp-image-8014 alignnone\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/09\/Egypt-flag-300x200.jpg\" alt=\"\" width=\"300\" height=\"200\" \/><\/p>\n<p>En agosto de 2018, la Autoridad Reguladora de Egipto anunci\u00f3 la extensi\u00f3n de los requisitos de registro para la colocaci\u00f3n de dispositivos m\u00e9dicos en el territorio.\u00a0Antes de esta comunicaci\u00f3n, solo los dispositivos de Clase III, los dispositivos est\u00e9riles de un solo uso (independientemente de la clase de riesgo) y todos los dispositivos invasivos estaban sujetos a registro.\u00a0Las clases de riesgo de referencia de la reglamentaci\u00f3n egipcia son las mismas que las establecidas por el <strong>MDR 93\/42\/CEE<\/strong> y sucesivas modificaciones y complementos.<\/p>\n<p>Hoy en d\u00eda, la Central Administration of Pharmaceutical Affairs (CAPA) requiere la presentaci\u00f3n de la solicitud de registro para todos los dispositivos m\u00e9dicos, a excepci\u00f3n de los dispositivos de la Clase I no est\u00e9riles y de diagn\u00f3stico in vitro.<\/p>\n<p>Para realizar el registro, los fabricantes locales o los representantes legales in situ (Egyption Registration Holder ERH) de los fabricantes extranjeros tienen que pedir (y obtener) una cita con el fin de presentar las solicitudes a la Autoridad Reguladora.<\/p>\n<p>&nbsp;<\/p>\n<p>Para m\u00e1s informaci\u00f3n:<\/p>\n<p><a href=\"http:\/\/www.eda.mohealth.gov.eg\/\" target=\"_blank\" rel=\"noopener\">http:\/\/www.eda.mohealth.gov.eg\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>En agosto de 2018, la Autoridad Reguladora de Egipto anunci\u00f3 la extensi\u00f3n de los requisitos de registro para la colocaci\u00f3n de  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","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":[],"tags":[],"class_list":["post-8019","post","type-post","status-publish","format-standard","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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