{"id":7092,"date":"2018-05-09T10:21:35","date_gmt":"2018-05-09T08:21:35","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=7092"},"modified":"2023-06-26T11:25:13","modified_gmt":"2023-06-26T09:25:13","slug":"registros-internacionales-fuera-de-la-ue","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/","title":{"rendered":"REGISTROS INTERNACIONALES EXTRA-UE"},"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-blend:overlay;--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\"><div style=\"float: left; width: 70%;\">\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-7062\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2017\/07\/GMP.jpg\" alt=\"\" width=\"259\" height=\"194\" \/><\/p>\n<p><strong>Hacia los mercados internacionales <\/strong><\/p>\n<p>Gracias a nuestra red de Agencias socias presentes en m\u00e1s de 20 pa\u00edses no europeos, realizamos las actividades de preparaci\u00f3n y apoyo al registro de dispositivos m\u00e9dicos y dispositivos m\u00e9dico-diagn\u00f3sticos in vitro ante las Autoridades Reguladoras Extranjeras.<\/p>\n<p><strong>Algunos servicios:<\/strong><\/p>\n<ul>\n<li>An\u00e1lisis de viabilidad de la comercializaci\u00f3n en el pa\u00eds destinatario.<\/li>\n<li>Identificaci\u00f3n de los requisitos de regulaci\u00f3n pre- y post-mercado.<\/li>\n<li><em>Pre-screening <\/em>de la documentaci\u00f3n para la adaptaci\u00f3n a la normativa internacional.<\/li>\n<li>Preparaci\u00f3n <em>dossier<\/em>\/pr\u00e1cticas de registro (510(k), MDAL, STED, ASEAN CSDT, dossier, etc.).<\/li>\n<li>Seguimiento pr\u00e1ctico posterior al reenv\u00edo.<\/li>\n<li><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/\"><strong>Servicio de <em>licence holding <\/em>y Representante Local.<\/strong><\/a><\/li>\n<li>Apoyo en la gesti\u00f3n de la correspondencia entre la empresa y la Autoridad Reguladora del Pa\u00eds de referencia.<\/li>\n<li>Renovaciones peri\u00f3dicas.<\/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=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\">Consultor\u00eda estrat\u00e9gico-regulatoria<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/apoyo-para-la-certificacion-ce\/\">Apoyo para la certificaci\u00f3n CE<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/registros-ministeriales-italianos-y-europeos\/\">Registros ministeriales italianos y europeos<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\">Registros internacionales extra-UE<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/\">Representante Local<\/a><\/p>\n<p><a href=\"https:\/\/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<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":10313,"parent":7086,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-7092","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>REGISTROS INTERNACIONALES EXTRA-UE - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"REGISTROS INTERNACIONALES EXTRA-UE - Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"article:modified_time\" content=\"2023-06-26T09:25:13+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\",\"url\":\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\",\"name\":\"REGISTROS INTERNACIONALES EXTRA-UE - Thema - Medical Regulatory Consultancy\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/#primaryimage\"},\"thumbnailUrl\":\"\",\"datePublished\":\"2018-05-09T08:21:35+00:00\",\"dateModified\":\"2023-06-26T09:25:13+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/#primaryimage\",\"url\":\"\",\"contentUrl\":\"\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.thema-med.com\/es\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Servicios\",\"item\":\"https:\/\/www.thema-med.com\/es\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"REGISTROS INTERNACIONALES EXTRA-UE\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#website\",\"url\":\"https:\/\/www.thema-med.com\/es\/\",\"name\":\"Thema - Medical Regulatory Consultancy\",\"description\":\"Quality and Regulatory Affairs for Medical Devices\",\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.thema-med.com\/es\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":[\"Organization\",\"Place\"],\"@id\":\"https:\/\/www.thema-med.com\/es\/#organization\",\"name\":\"Thema\",\"alternateName\":\"Thema\",\"url\":\"https:\/\/www.thema-med.com\/es\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"contentUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"width\":2440,\"height\":2851,\"caption\":\"Thema\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/\"],\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"REGISTROS INTERNACIONALES EXTRA-UE - Thema - Medical Regulatory Consultancy","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/","og_locale":"es_ES","og_type":"article","og_title":"REGISTROS INTERNACIONALES EXTRA-UE - Thema - Medical Regulatory Consultancy","og_url":"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/","og_site_name":"Thema - Medical Regulatory Consultancy","article_modified_time":"2023-06-26T09:25:13+00:00","twitter_card":"summary_large_image","twitter_misc":{"Tiempo de lectura":"2 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/","url":"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/","name":"REGISTROS INTERNACIONALES EXTRA-UE - Thema - Medical Regulatory Consultancy","isPartOf":{"@id":"https:\/\/www.thema-med.com\/es\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/#primaryimage"},"image":{"@id":"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/#primaryimage"},"thumbnailUrl":"","datePublished":"2018-05-09T08:21:35+00:00","dateModified":"2023-06-26T09:25:13+00:00","breadcrumb":{"@id":"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/#primaryimage","url":"","contentUrl":""},{"@type":"BreadcrumbList","@id":"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.thema-med.com\/es\/"},{"@type":"ListItem","position":2,"name":"Servicios","item":"https:\/\/www.thema-med.com\/es\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/"},{"@type":"ListItem","position":3,"name":"REGISTROS INTERNACIONALES EXTRA-UE"}]},{"@type":"WebSite","@id":"https:\/\/www.thema-med.com\/es\/#website","url":"https:\/\/www.thema-med.com\/es\/","name":"Thema - Medical Regulatory Consultancy","description":"Quality and Regulatory Affairs for Medical Devices","publisher":{"@id":"https:\/\/www.thema-med.com\/es\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.thema-med.com\/es\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":["Organization","Place"],"@id":"https:\/\/www.thema-med.com\/es\/#organization","name":"Thema","alternateName":"Thema","url":"https:\/\/www.thema-med.com\/es\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/","url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","contentUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","width":2440,"height":2851,"caption":"Thema"},"image":{"@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/"],"mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/"}}]}},"_links":{"self":[{"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/pages\/7092","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/comments?post=7092"}],"version-history":[{"count":2,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/pages\/7092\/revisions"}],"predecessor-version":[{"id":28362,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/pages\/7092\/revisions\/28362"}],"up":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/pages\/7086"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/"}],"wp:attachment":[{"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/media?parent=7092"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}