{"id":7101,"date":"2018-05-09T10:23:14","date_gmt":"2018-05-09T08:23:14","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=7101"},"modified":"2022-07-29T17:36:56","modified_gmt":"2022-07-29T15:36:56","slug":"registros-ministeriales-italianos-y-europeos","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/es\/servicios\/registros-ministeriales-italianos-y-europeos\/","title":{"rendered":"REGISTROS MINISTERIALES ITALIANOS Y EUROPEOS"},"content":{"rendered":"<div style=\"float: left; width: 70%;\">\n<p><img decoding=\"async\" class=\"alignnone wp-image-22485 size-fusion-400\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/07\/schacherer-1000-830x598-1-400x288.jpg\" alt=\"\" width=\"400\" height=\"288\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/07\/schacherer-1000-830x598-1-200x144.jpg 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/07\/schacherer-1000-830x598-1-300x216.jpg 300w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/07\/schacherer-1000-830x598-1-400x288.jpg 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/07\/schacherer-1000-830x598-1-600x432.jpg 600w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/07\/schacherer-1000-830x598-1-768x553.jpg 768w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/07\/schacherer-1000-830x598-1-800x576.jpg 800w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/07\/schacherer-1000-830x598-1.jpg 830w\" sizes=\"(max-width: 400px) 100vw, 400px\" \/><\/p>\n<p><strong>Nuestra experiencia al servicio de las nuevas introducciones en el mercado <\/strong><\/p>\n<p>Realizamos todas las actividades de preparaci\u00f3n y apoyo al registro de dispositivos m\u00e9dicos y dispositivos m\u00e9dico-diagn\u00f3sticos in vitro ante las Autoridades Competentes europeas, incluida la italiana.<\/p>\n<p>Podemos elaborar la documentaci\u00f3n necesaria, realizar las solicitudes y gestionar eficazmente todas las fases de la registraci\u00f3n de vuestros dispositivos m\u00e9dicos e IVD.<\/p>\n<p><strong>Algunos servicios:<\/strong><\/p>\n<ul>\n<li>Registro de Operador Econ\u00f3mico (Fabricantes UE y no UE, Representantes Autorizados, Fabricantes de Sistemas e Importadores de Dispositivos M\u00e9dicos y Dispositivos M\u00e9dicos &#8211; Diagn\u00f3stico in Vitro) en Eudamed.\u00a0Los expertos de Thema est\u00e1n disponibles para proceder en su nombre o apoyarle en el registro EUDAMED hasta la notificaci\u00f3n al Ministerio de Sanidad del Estado miembro donde tiene su sede el operador econ\u00f3mico que presenta la solicitud. Luego, el Ministerio emitir\u00e1 el SRN (N\u00famero \u00danico de Registro) al momento de la activaci\u00f3n de la autorizaci\u00f3n.<\/li>\n<li><em>Gap analysis\u00a0<\/em>de evaluaci\u00f3n para la notificaci\u00f3n\/registro en los Ministerios de Sanidad de los Estados Miembros.<\/li>\n<li>Adaptaci\u00f3n <em>labelling <\/em>(etiqueta, instrucciones de uso).<\/li>\n<li>Notificaciones\/registros de dispositivos en las bases de datos ministeriales.<\/li>\n<li>Solicitudes de autorizaci\u00f3n publicidad sanitaria.<\/li>\n<\/ul>\n<\/div>\n<div id=\"serviceslist\" style=\"float: left; width: 27%; margin-left: 1.5%; padding-left: 1.5%; border-left: 1px solid;\">\n<p><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/kit-de-emergencia-ivdr\/\">Kit de Emergencia IVDR<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/nuevo-kit-de-emergencia-mdr\/\">Kit de Emergencia MDR<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\">Consultor\u00eda estrat\u00e9gico-regulatoria<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/es\/servicios\/apoyo-para-la-certificacion-ce\/\">Apoyo para la certificaci\u00f3n CE<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/es\/servicios\/registros-ministeriales-italianos-y-europeos\/\">Registros ministeriales italianos y europeos<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\">Registros internacionales extra-UE<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/es\/servicios\/representante-local\/\">Representante Local<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/es\/servicios\/callida-y-bpf-internacionales\/\">Calidad y BPF internacionales<\/a><\/p>\n<\/div>\n<div style=\"float: none; clear: both;\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Nuestra experiencia al servicio de las nuevas introducciones en el mercado Realizamos todas las actividades de preparaci\u00f3n y apoyo al registro  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":10313,"parent":7086,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-7101","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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