{"id":21837,"date":"2022-07-25T13:17:43","date_gmt":"2022-07-25T11:17:43","guid":{"rendered":"http:\/\/www.thema-med.eu\/?page_id=21837"},"modified":"2025-07-10T15:05:29","modified_gmt":"2025-07-10T13:05:29","slug":"faq-spagnolo","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/es\/faq-spagnolo\/","title":{"rendered":"FAQ"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 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\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-margin-top:0px;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><h2><strong>UDI en productos sanitarios: obligaciones, etiquetado y requisitos seg\u00fan MDR (UE) 2017\/745 e IVDR (UE) 2017\/745<\/strong><\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-1 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-pagination fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-1 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-1 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-pagination fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"1\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-1-post-34453\" class=\"fusion-post-grid post-34453 post type-post status-publish format-standard hentry category-faq-es category-udi-en-productos-sanitarios tag-dispositivos-de-diagnostico-in-vitro tag-identificacion-de-productos-sanitarios tag-ivd-es-2 tag-productos-sanitarios-es tag-trazabilidad-de-productos-sanitarios tag-udi-es-2 tag-udi-ivd-es tag-udi-di-es tag-udi-pi-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/que-es-y-para-que-sirve-la-udi-para-productos-sanitarios-y-de-diagnostico-in-vitro\/\">\u00bfQu\u00e9 es y para qu\u00e9 sirve la UDI para productos sanitarios y de diagn\u00f3stico in vitro?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34451\" class=\"fusion-post-grid post-34451 post type-post status-publish format-standard hentry category-faq-es category-udi-en-productos-sanitarios\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/que-es-el-udi-di-basico-y-en-que-se-diferencia-del-udi\/\">\u00bfQu\u00e9 es el UDI-DI B\u00e1sico y en qu\u00e9 se diferencia del UDI?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34449\" class=\"fusion-post-grid post-34449 post type-post status-publish format-standard hentry category-faq-es category-udi-en-productos-sanitarios\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/que-productos-sanitarios-deben-llevar-un-codigo-udi\/\">\u00bfQu\u00e9 productos sanitarios deben llevar un c\u00f3digo UDI?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34442\" class=\"fusion-post-grid post-34442 post type-post status-publish format-standard hentry category-faq-es category-udi-en-productos-sanitarios\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/cuales-son-los-plazos-obligatorios-para-adoptar-el-sistema-udi\/\">\u00bfCu\u00e1les son los plazos obligatorios para adoptar el sistema UDI?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34440\" class=\"fusion-post-grid post-34440 post type-post status-publish format-standard hentry category-faq-es category-udi-en-productos-sanitarios\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/cual-es-la-diferencia-entre-codigo-udi-y-soporte-udi\/\">\u00bfCu\u00e1l es la diferencia entre c\u00f3digo UDI y soporte UDI?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34433\" class=\"fusion-post-grid post-34433 post type-post status-publish format-standard hentry category-faq-es category-udi-en-productos-sanitarios\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/como-debe-figurar-el-udi-en-la-etiqueta-y-el-embalaje-del-producto\/\">\u00bfC\u00f3mo debe figurar el UDI en la etiqueta y el embalaje del producto?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34431\" class=\"fusion-post-grid post-34431 post type-post status-publish format-standard hentry category-faq-es category-udi-en-productos-sanitarios\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/donde-y-como-se-registra-la-udi-en-eudamed\/\">\u00bfD\u00f3nde y c\u00f3mo se registra la UDI en EUDAMED?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34428\" class=\"fusion-post-grid post-34428 post type-post status-publish format-standard hentry category-faq-es category-udi-en-productos-sanitarios\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/quien-es-responsable-de-colocar-el-codigo-udi-en-los-productos-sanitarios-etiquetas-y-envases\/\">\u00bfQui\u00e9n es responsable de colocar el c\u00f3digo UDI en los productos sanitarios, etiquetas y envases?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34426\" class=\"fusion-post-grid post-34426 post type-post status-publish format-standard hentry category-faq-es category-udi-en-productos-sanitarios\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/deben-tener-un-codigo-udi-los-productos-heredados-mdd-aimdd\/\">\u00bfDeben tener un c\u00f3digo UDI los productos heredados (MDD\/AIMDD)?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34424\" class=\"fusion-post-grid post-34424 post type-post status-publish format-standard hentry category-faq-es category-udi-en-productos-sanitarios\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/para-que-productos-sanitarios-establece-el-mdr-requisitos-udi-especificos\/\">\u00bfPara qu\u00e9 productos sanitarios establece el MDR requisitos UDI espec\u00edficos?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34422\" class=\"fusion-post-grid post-34422 post type-post status-publish format-standard hentry category-faq-es category-udi-en-productos-sanitarios\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/cuales-son-los-requisitos-para-el-registro-udi-de-sistemas-y-kits-de-procedimientos\/\">\u00bfCu\u00e1les son los requisitos para el registro UDI de sistemas y kits de procedimientos?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34420\" class=\"fusion-post-grid post-34420 post type-post status-publish format-standard hentry category-faq-es category-udi-en-productos-sanitarios tag-reglamento-ivdr tag-codigo-udi tag-dispositivos-heredados-es tag-etiquetado-de-productos-sanitarios tag-etiquetas-udi tag-gs1-es tag-identificacion-de-productos-sanitarios tag-ivd-es-2 tag-marcado-directo-udi tag-obligaciones-udi tag-plazos-udi tag-portador-udi tag-reglamento-mdr tag-soporte-udi tag-trazabilidad-productos-sanitarios tag-udi-es-2 tag-udi-de-productos-sanitarios tag-udi-ivd-es tag-udi-di-es tag-udi-di-basico tag-udi-pi-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/cual-es-el-formato-correcto-de-la-fecha-de-caducidad-que-debe-figurar-en-el-vector-udi\/\">\u00bfCu\u00e1l es el formato correcto de la fecha de caducidad que debe figurar en el vector UDI?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-2\"><h2><strong>Transici\u00f3n a la certificaci\u00f3n MDR (UE) 2017\/745<\/strong><\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-2 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-pagination fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-2 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-2 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-pagination fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"1\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-2-post-32357\" class=\"fusion-post-grid post-32357 post type-post status-publish format-standard hentry category-faq-es category-transicion-a-la-certificacion-mdr-ue-2017-745\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2024\/04\/11\/basta-con-reajustar-la-documentacion-tecnica-existente\/\">\u00bfBasta con reajustar la documentaci\u00f3n t\u00e9cnica existente?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-2-post-32356\" class=\"fusion-post-grid post-32356 post type-post status-publish format-standard hentry category-faq-es category-transicion-a-la-certificacion-mdr-ue-2017-745\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2024\/04\/11\/si-el-organismo-regulador-ha-aprobado-la-solicitud-de-certificacion-en-el-pasado-es-mas-probable-que-la-apruebe-tras-la-transicion-al-mdr-ue-2017-745\/\">Si el organismo regulador ha aprobado la solicitud de certificaci\u00f3n en el pasado, \u00bfes m\u00e1s probable que la apruebe tras la transici\u00f3n al MDR (UE) 2017\/745?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-2-post-32354\" class=\"fusion-post-grid post-32354 post type-post status-publish format-standard hentry category-faq-es category-transicion-a-la-certificacion-mdr-ue-2017-745\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2024\/04\/11\/si-el-producto-no-hubiera-cambiado-y-nunca-hubiera-tenido-problemas-podria-tener-problemas-con-el-mdr-ue-2017-745\/\">Si el producto no hubiera cambiado y nunca hubiera tenido problemas, \u00bfpodr\u00eda tener problemas con el MDR (UE) 2017\/745?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-2-post-32352\" class=\"fusion-post-grid post-32352 post type-post status-publish format-standard hentry category-faq-es category-transicion-a-la-certificacion-mdr-ue-2017-745\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2024\/04\/11\/es-suficiente-recurrir-a-una-consultoria-externa-para-obtener-la-certificacion-ce\/\">\u00bfEs suficiente recurrir a una consultor\u00eda externa para obtener la certificaci\u00f3n CE?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-2-post-32350\" class=\"fusion-post-grid post-32350 post type-post status-publish format-standard hentry category-faq-es category-transicion-a-la-certificacion-mdr-ue-2017-745\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2024\/04\/11\/es-posible-obtener-rapidamente-la-certificacion-ce\/\">\u00bfEs posible obtener r\u00e1pidamente la certificaci\u00f3n CE?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-2-post-32348\" class=\"fusion-post-grid post-32348 post type-post status-publish format-standard hentry category-faq-es category-transicion-a-la-certificacion-mdr-ue-2017-745\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2024\/04\/11\/de-que-sirve-tener-la-certificacion-iso-13485\/\">\u00bfDe qu\u00e9 sirve tener la certificaci\u00f3n ISO 13485?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-2-post-32346\" class=\"fusion-post-grid post-32346 post type-post status-publish format-standard hentry category-faq-es category-transicion-a-la-certificacion-mdr-ue-2017-745\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2024\/04\/11\/puede-ocurrir-que-se-deniegue-o-retire-un-certificado-ce\/\">\u00bfPuede ocurrir que se deniegue o retire un certificado CE?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-3\" style=\"--awb-margin-top:35px;\"><h2>Actualizaci\u00f3n de la normativa<\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-3 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-pagination fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-3 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-3 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-pagination fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"1\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-3-post-30300\" class=\"fusion-post-grid post-30300 post type-post status-publish format-standard hentry category-actualizacion-de-la-normativa category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2023\/09\/20\/que-es-un-documento-o-lista-de-origen-externo\/\">\u00bfQu\u00e9 es un documento o lista de origen externo?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-3-post-30306\" class=\"fusion-post-grid post-30306 post type-post status-publish format-standard hentry category-actualizacion-de-la-normativa category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2023\/09\/20\/por-que-es-necesario-implantar-y-gestionar-el-proceso-de-cumplimiento-de-normas-leyes-y-reglamentos\/\">\u00bfPor qu\u00e9 es necesario implantar y gestionar el proceso de cumplimiento de normas, leyes y reglamentos?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-3-post-30310\" class=\"fusion-post-grid post-30310 post type-post status-publish format-standard hentry category-actualizacion-de-la-normativa category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2023\/09\/20\/de-que-depende-la-lista-de-documentos-de-origen-externo\/\">\u00bfDe qu\u00e9 depende la lista de documentos de origen externo?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-3-post-30314\" class=\"fusion-post-grid post-30314 post type-post status-publish format-standard hentry category-actualizacion-de-la-normativa category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2023\/09\/20\/quien-controla-la-actualizacion-de-los-documentos-de-origen-externo\/\">\u00bfQui\u00e9n controla la actualizaci\u00f3n de los documentos de origen externo?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-4\" style=\"--awb-margin-top:35px;\"><h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">Swiss &#8211; Exit: los requisitos para comercializar Dispositivos M\u00e9dicos en Suiza<\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-4 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-pagination fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-4 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-4 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-pagination fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"1\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-4-post-19734\" class=\"fusion-post-grid post-19734 post type-post status-publish format-standard hentry category-faq-es category-suiza-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2021\/12\/14\/swiss-exit-que-requisitos-deben-cumplir-ahora-los-fabricantes-de-productos-medicos-de-la-ue\/\">Swiss Exit: \u00bfQu\u00e9 requisitos deben cumplir ahora los Fabricantes de Dispositivos M\u00e9dicos de la UE?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-4-post-19732\" class=\"fusion-post-grid post-19732 post type-post status-publish format-standard hentry category-faq-es category-suiza-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2021\/12\/14\/porque-suiza-se-considera-un-pais-tercero-para-la-ue\/\">\u00bfPorque Suiza se considera un pa\u00eds tercero para la UE?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-4-post-19736\" class=\"fusion-post-grid post-19736 post type-post status-publish format-standard hentry category-faq-es category-suiza-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2021\/12\/14\/para-que-productos-medicos-es-necesario-designar-a-un-representante-autorizado-suizo\/\">\u00bfPara qu\u00e9 Dispositivos M\u00e9dicos es necesario designar a un Representante Autorizado Suizo?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-4-post-19741\" class=\"fusion-post-grid post-19741 post type-post status-publish format-standard hentry category-faq-es category-suiza-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2021\/12\/14\/deben-registrarse-en-eudamed-los-representantes-autorizados-y-los-importadores-suizos-de-dispositivos-medicos\/\">\u00bfDeben registrarse en EUDAMED los Representantes Autorizados y los Importadores Suizos de Dispositivos M\u00e9dicos?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-5\" style=\"--awb-margin-top:35px;\"><h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">IVDR (EU) 2017\/746<\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-5 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-5 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-5 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"0\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-5-post-15431\" class=\"fusion-post-grid post-15431 post type-post status-publish format-standard hentry category-faq-es category-ivdr-es-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2020\/08\/20\/periodos-transicion-ivd-pueden-seguir-comercializandose-despues-26-mayo-2022\/\">Periodos de transici\u00f3n: \u00bflos Dispositivos M\u00e8dico-Diagn\u00f3sticos in Vitro, conformes con IVDD, pueden seguir comercializ\u00e1ndose en la UE despu\u00e9s del 26 de mayo de 2022?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-5-post-15429\" class=\"fusion-post-grid post-15429 post type-post status-publish format-standard hentry category-faq-es category-ivdr-es-faq-es category-ivdr-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2020\/08\/20\/disposicion-sell-off-ivdr-ue-2017-746\/\">\u00bfQu\u00e9 es la disposici\u00f3n de fin de venta (\u201csell off\u201d)?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-5-post-15427\" class=\"fusion-post-grid post-15427 post type-post status-publish format-standard hentry category-faq-es category-ivdr-es-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2020\/08\/20\/autocertificar-los-dispositivos-ambito-ivdr-2017-746\/\">\u00bfEs posible autocertificar los dispositivos en al \u00e1mbito de la Regulaci\u00f3n sobre los Dispositivos M\u00e9dico-Diagn\u00f3sticos in Vitro IVDR (UE) 2017\/746?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-5-post-15425\" class=\"fusion-post-grid post-15425 post type-post status-publish format-standard hentry category-faq-es category-ivdr-es-faq-es category-ivdr-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2020\/08\/20\/principales-modificaciones-previstas-en-ivdr-2017-746\/\">\u00bfCu\u00e1les son las principales modificaciones previstas en la regulaci\u00f3n sobre los Dispositivos M\u00e9dico-Diagn\u00f3sticos in Vitro IVDR (UE) 2017\/746?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-5-post-15421\" class=\"fusion-post-grid post-15421 post type-post status-publish format-standard hentry category-faq-es category-faq category-ivdr-es-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2020\/08\/20\/ivdr-2017-746-en-que-modo-influye-sistema-gestion-calidad\/\">\u00bfEn qu\u00e9 modo la Regulaci\u00f3n sobre los Dispositivos M\u00e9dico-Diagn\u00f3sticos in Vitro (IVDR) influye en el Sistema de Gesti\u00f3n de la Calidad?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-5-post-15419\" class=\"fusion-post-grid post-15419 post type-post status-publish format-standard hentry category-faq-es category-ivdr-es-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2020\/08\/20\/cuando-deben-los-fabricantes-de-ivd-cumplir-la-ivdr-2017-746\/\">\u00bfCu\u00e1ndo tienen que cumplir los Fabricantes de productos sanitarios de diagn\u00f3stico in vitro con el IVDR (UE) 2017\/746?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-5-post-15417\" class=\"fusion-post-grid post-15417 post type-post status-publish format-standard hentry category-faq-es category-ivdr-es-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2020\/08\/20\/ivdr-2017-746-regulacion-ue\/\">\u00bfCu\u00e1l es el Reglamento de productos sanitarios para diagn\u00f3stico in vitro IVDR (UE) 2017\/746 y cuando se aplica?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-6\" style=\"--awb-margin-top:35px;\"><h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">\u00bfCu\u00e1l ser\u00e1 el impacto de MDR (EU) 2017\/745 en los certificados CE MDD en \u00abper\u00edodo de gracia\u00bb?<\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-6 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-6 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-6 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"0\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-6-post-15722\" class=\"fusion-post-grid post-15722 post type-post status-publish format-standard hentry category-impacto-mdr-en-los-certificados-ce-mdd-period-of-grace category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2019\/06\/12\/que-es-el-period-of-grace-y-como-puedo-disfrutarlo\/\">\u00bfQu\u00e9 es el \u201cperiod of grace\u201d y c\u00f3mo puedo disfrutarlo?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-6-post-15795\" class=\"fusion-post-grid post-15795 post type-post status-publish format-standard hentry category-impacto-mdr-en-los-certificados-ce-mdd-period-of-grace category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2019\/06\/12\/que-diferencia-hay-entre-vigilancia-del-mercado-vigilancia-posterior-al-mercado-pmd-y-vigilancia\/\">\u00bfQu\u00e9 diferencia hay entre vigilancia del mercado, vigilancia posterior al mercado (PMD) y vigilancia?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-6-post-15798\" class=\"fusion-post-grid post-15798 post type-post status-publish format-standard has-post-thumbnail hentry category-impacto-mdr-en-los-certificados-ce-mdd-period-of-grace category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2019\/06\/12\/que-es-el-sistema-de-vigilancia-posterior-al-mercado\/\">\u00bfQu\u00e9 es el \u201csistema de vigilancia posterior al mercado\u201d?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-6-post-15786\" class=\"fusion-post-grid post-15786 post type-post status-publish format-standard hentry category-impacto-mdr-en-los-certificados-ce-mdd-period-of-grace category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2019\/06\/12\/como-puedo-seguir-vendiendo-mis-dispositivos-despues-de-la-plena-aplicacion-del-mdr\/\">\u00bfComo puedo seguir vendiendo mis dispositivos despu\u00e9s de la plena aplicaci\u00f3n del MDR?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-7\" style=\"--awb-margin-top:35px;\"><\/p>\n<h2>C\u00f3mo registrar dispositivos m\u00e9dicos que emiten radiaci\u00f3n con el CDRH<\/h2>\n<p><!-- \/wp:post-content --><\/p>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-7 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-7 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-7 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"0\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-7-post-7832\" class=\"fusion-post-grid post-7832 post type-post status-publish format-standard hentry category-como-registrar-dispositivos-medicos-que-emiten-radiaciones-en-el-cdrh-es-faq-es category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2018\/08\/29\/que-es-el-product-initial-report-para-el-cdrh\/\">\u00bfQu\u00e9 es el Product (Initial) Report para el CDRH?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-7-post-7828\" class=\"fusion-post-grid post-7828 post type-post status-publish format-standard hentry category-como-registrar-dispositivos-medicos-que-emiten-radiaciones-en-el-cdrh-es-faq-es category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2018\/08\/29\/que-es-el-numero-de-ingreso\/\">\u00bfQu\u00e9 es el N\u00famero de ingreso?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-7-post-7822\" class=\"fusion-post-grid post-7822 post type-post status-publish format-standard hentry category-como-registrar-dispositivos-medicos-que-emiten-radiaciones-en-el-cdrh-es-faq-es category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2018\/08\/29\/que-dispositivos-medicos-clasifican-como-productos-electronicos-que-emiten-radiaciones\/\">\u00bfQu\u00e9 dispositivos m\u00e9dicos se clasifican como productos electr\u00f3nicos que emiten radiaciones?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-7-post-7818\" class=\"fusion-post-grid post-7818 post type-post status-publish format-standard hentry category-como-registrar-dispositivos-medicos-que-emiten-radiaciones-en-el-cdrh-es-faq-es category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2018\/08\/29\/que-hace-el-cdrh\/\">\u00bfQu\u00e9 hace el CDRH?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-8\" style=\"--awb-margin-top:35px;\"><p><!-- wp:html \/--><\/p>\n<h2>\u00bfPor qu\u00e9 es necesario el marcado CE?<\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-8 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-8 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-8 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"0\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-8-post-7288\" class=\"fusion-post-grid post-7288 post type-post status-publish format-standard hentry category-porque-es-necesario-el-marcado-ce category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/\">\u00bfC\u00f3mo afectar\u00e1 el IVDR 2017\/746 a la Gesti\u00f3n del Sistema de Calidad?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-8-post-7275\" class=\"fusion-post-grid post-7275 post type-post status-publish format-standard hentry category-porque-es-necesario-el-marcado-ce category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/cuales-son-los-principales-cambios-en-comparacion-la-directiva-9879ce-anterior\/\">\u00bfCu\u00e1les son los principales cambios en comparaci\u00f3n con la Directiva 98\/79\/CE anterior?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-8-post-7264\" class=\"fusion-post-grid post-7264 post type-post status-publish format-standard hentry category-porque-es-necesario-el-marcado-ce category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/cuando-entrara-en-vigencia-el-ivdr-2017746\/\">\u00bfCu\u00e1ndo entrar\u00e1 en vigencia el IVDR 2017\/746?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-8-post-3730\" class=\"fusion-post-grid post-3730 post type-post status-publish format-standard hentry category-porque-es-necesario-el-marcado-ce category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2017\/07\/19\/cuando-tengo-que-nominar-un-mandatario\/\">\u00bfCu\u00e1ndo se debe designar a un representante?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-8-post-3728\" class=\"fusion-post-grid post-3728 post type-post status-publish format-standard hentry category-porque-es-necesario-el-marcado-ce category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2017\/07\/19\/como-consiguo-definir-la-clase-de-riesgo-del-dispositivo-medico\/\">\u00bfC\u00f3mo se consigue definir la clase de riesgo de un dispositivo m\u00e9dico?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-8-post-3732\" class=\"fusion-post-grid post-3732 post type-post status-publish format-standard hentry category-porque-es-necesario-el-marcado-ce category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2017\/07\/18\/que-es-un-contrato-obl\/\">\u00bfQu\u00e9 es un contrato OBL?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-9\" style=\"--awb-margin-top:35px;\"><p><!-- wp:html \/--><\/p>\n<h2>\u00bfQu\u00e9 es una estrategia regulatoria?<\/h2>\n<p><!-- \/wp:heading --><\/p>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-9 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-9 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-9 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-2 isotope fusion-blog-equal-heights\" data-pages=\"0\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-9-post-3724\" class=\"fusion-post-grid post-3724 post type-post status-publish format-standard hentry category-que-es-una-estrategia-regulatoria category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2017\/07\/18\/donde-encuentro-las-informaciones-que-necesito-para-vender-mis-dispositivos\/\">\u00bfD\u00f3nde se encuentran las informaciones necesarias para vender los dispositivos?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-10\" style=\"--awb-margin-top:35px;\"><h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">\u00bfCu\u00e1les son los requisitos GMP?<\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-10 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-10 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-10 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"0\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-10-post-6806\" class=\"fusion-post-grid post-6806 post type-post status-publish format-standard hentry category-que-son-los-requisitos-gmp-faq-es category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2019\/08\/23\/que-es-el-mdsap\/\">\u00bfQu\u00e9 es el MDSAP?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-10-post-3743\" class=\"fusion-post-grid post-3743 post type-post status-publish format-standard hentry category-que-son-los-requisitos-gmp-faq-es category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2017\/07\/19\/cgmp-fda-cuando-puedo-excluir-la-planificacion-de-mi-sistema-cualidad-segun-las-cgmp-americanas\/\">cGMP FDA: \u00bfcu\u00e1ndo se puede excluir el dise\u00f1o del sistema de calidad seg\u00fan las cGMP estadounidenses?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-10-post-3741\" class=\"fusion-post-grid post-3741 post type-post status-publish format-standard hentry category-que-son-los-requisitos-gmp-faq-es category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2017\/07\/19\/cuantas-revisiones-tengo-que-prever-en-fase-de-planificacion-de-mi-projecto\/\">\u00bfCu\u00e1ntas revisiones hay que prever en la fase de dise\u00f1o del dispositivo?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-10-post-3739\" class=\"fusion-post-grid post-3739 post type-post status-publish format-standard hentry category-que-son-los-requisitos-gmp-faq-es category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2017\/07\/19\/vender-en-canada-cuales-son-las-obligaciones-de-comunicacion-previstas-en-la-directiva-sor-98-282\/\">Vender en Canad\u00e1: \u00bfCu\u00e1les son las obligaciones de informaci\u00f3n previstas en la Directiva SOR 98-282?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-10-post-3737\" class=\"fusion-post-grid post-3737 post type-post status-publish format-standard hentry category-que-son-los-requisitos-gmp-faq-es category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2017\/07\/19\/3737\/\">GMP FDA: \u00bfcu\u00e1les procesos productivos hay que validar?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-11\" style=\"--awb-margin-top:35px;\"><p><!-- wp:html --><\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">C\u00f3mo registrar dispositivos m\u00e9dicos en el mundo<\/h2>\n<p><!-- wp:shortcode --><\/p>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-11 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-11 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-11 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"0\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-11-post-3718\" class=\"fusion-post-grid post-3718 post type-post status-publish format-standard hentry category-como-registrar-los-dispositivos-medicos-en-el-mundo-faq-es category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2017\/07\/19\/vender-en-canada-cual-es-la-diferencia-entre-mdal-y-mdel\/\">Vender en Canad\u00e1: \u00bfcu\u00e1l es la diferencia entre MDAL y MDEL?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-11-post-3712\" class=\"fusion-post-grid post-3712 post type-post status-publish format-standard hentry category-como-registrar-los-dispositivos-medicos-en-el-mundo-faq-es category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2017\/07\/18\/vender-en-brasil-tengo-que-obtener-la-marca-inmetro\/\">Vender en Brasil: \u00bfhay que obtener el marcado INMETRO?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-11-post-3708\" class=\"fusion-post-grid post-3708 post type-post status-publish format-standard hentry category-como-registrar-los-dispositivos-medicos-en-el-mundo-faq-es category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2017\/07\/18\/que-es-la-510k\/\">\u00bfQu\u00e9 es la 510(k)?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-11-post-3706\" class=\"fusion-post-grid post-3706 post type-post status-publish format-standard hentry category-como-registrar-los-dispositivos-medicos-en-el-mundo-faq-es category-faq-es\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/es\/2017\/07\/18\/vender-en-china-que-responsabilidades-tiene-el-legal-agent\/\">Vender en China: \u00bfqu\u00e9 responsabilidades tiene un Agente Autorizado?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 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\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-margin-top:0px;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-3 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-2 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-12\"><p>&nbsp;<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/p>","protected":false},"excerpt":{"rendered":"","protected":false},"author":114,"featured_media":0,"parent":0,"menu_order":0,"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-21837","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FAQ - 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\/faq-spagnolo\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta 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