{"id":12944,"date":"2025-08-25T12:09:05","date_gmt":"2025-08-25T15:09:05","guid":{"rendered":"https:\/\/sobelconsult.com\/nuestras-soluciones-diagnostico-in-vitro-div-ee-uu\/registro-de-div-en-brasil-apoyo-reglamentario-completo\/"},"modified":"2026-04-10T09:57:28","modified_gmt":"2026-04-10T12:57:28","slug":"brazil-ivd-registration-full-regulatory-support","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/es\/nuestras-soluciones-diagnostico-in-vitro-div-ee-uu\/brazil-ivd-registration-full-regulatory-support\/","title":{"rendered":"Registro de DIV en Brasil | Apoyo reglamentario completo"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"12944\" class=\"elementor elementor-12944 elementor-12933\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c2a2983 e-flex e-con-boxed e-con e-parent\" data-id=\"c2a2983\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-230ad8b elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"230ad8b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Registro y notificaci\u00f3n de diagn\u00f3stico in vitro en Brasil<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c78a2a4 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"c78a2a4\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"From notification to full registration, Sobel simplifies every step with strategic expertise, helping your IVD reach the Brazilian market with confidence.\"}]\" data-inline-monday=\"true\">Desde la notificaci\u00f3n hasta el registro completo, Sobel simplifica cada paso con experiencia estrat\u00e9gica, ayudando a que tu diagn\u00f3stico in vitro (IVD) llegue al mercado brasile\u00f1o con confianza.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4952b75 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"4952b75\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Consigue ayuda de expertos<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ef7ea76 animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"ef7ea76\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f658881 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"f658881\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Experiencia regulatoria para el registro y la notificaci\u00f3n de diagn\u00f3stico in vitro en Brasil<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53462a9 elementor-widget elementor-widget-text-editor\" data-id=\"53462a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Between technical dossier preparation, document validation, and compliance with Anvisa\u2019s latest standards, the process can be complex and time-consuming. Sobel turns this challenge into a clear, compliant pathway to market.\"}]\" data-inline-monday=\"true\">Entre la preparaci\u00f3n del expediente t\u00e9cnico, la validaci\u00f3n de los documentos y el cumplimiento de las \u00faltimas normas de Anvisa, el proceso puede ser complejo y llevar mucho tiempo. Sobel convierte este reto en un camino claro y conforme al mercado. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5598d9c e-flex e-con-boxed e-con e-parent\" data-id=\"5598d9c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-19130d5 e-con-full e-flex e-con e-child\" data-id=\"19130d5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-504d823 e-con-full e-transform e-flex e-con e-child\" data-id=\"504d823\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation_mobile&quot;:&quot;fadeIn&quot;,&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:96,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-109,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e813834 elementor-widget elementor-widget-heading\" data-id=\"e813834\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">\u00bfPara qui\u00e9n?<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c0df2ef elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"c0df2ef\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-053e4d9 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"053e4d9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Para fabricantes y partes interesadas que necesiten apoyo normativo para los DIV en Brasil.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Los fabricantes internacionales de diagn\u00f3stico in vitro (IVD) que se preparan para registrar nuevos productos ante Anvisa.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Empresas que ampl\u00edan su cartera de diagn\u00f3stico in vitro y necesitan orientaci\u00f3n sobre las v\u00edas de notificaci\u00f3n y registro.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Distribuidores y socios locales que necesitan apoyo experto para mantener los productos de diagn\u00f3stico in vitro conformes y actualizados en Brasil.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4625e69 e-con-full e-flex e-con e-child\" data-id=\"4625e69\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation_mobile&quot;:&quot;fadeIn&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1859f8b elementor-widget elementor-widget-image\" data-id=\"1859f8b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"730\" height=\"1024\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/08\/fundo-element-730x1024.png\" class=\"attachment-large size-large wp-image-12406\" alt=\"IVD products registration Anvisa.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/08\/fundo-element-730x1024.png 730w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/08\/fundo-element-214x300.png 214w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/08\/fundo-element-768x1078.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/08\/fundo-element-1094x1536.png 1094w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/08\/fundo-element.png 1145w\" sizes=\"(max-width: 730px) 100vw, 730px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-62bbf79 e-flex e-con-boxed e-con e-parent\" data-id=\"62bbf79\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5ae62f1 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"5ae62f1\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"By partnering with Sobel, you align your IVD device with current Anvisa expectations\u2014whether you're working with a Class I device or a complex Class IV solution.\"}]\" data-inline-monday=\"true\">Al asociarte con Sobel, alineas tu producto de diagn\u00f3stico in vitro con las expectativas actuales de Anvisa, tanto si trabajas con un dispositivo de Clase I como con una soluci\u00f3n compleja de Clase IV.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-46fe04f elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"46fe04f\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">\u00a1Consigue apoyo!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bbf5e6e e-flex e-con-boxed e-con e-parent\" data-id=\"bbf5e6e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-93ba554 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"93ba554\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1380\" height=\"368\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/07\/Ellipse-6-1.png\" class=\"attachment-full size-full wp-image-10623\" alt=\"Ellipse element, coral color.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/07\/Ellipse-6-1.png 1380w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/07\/Ellipse-6-1-300x80.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/07\/Ellipse-6-1-1024x273.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/07\/Ellipse-6-1-768x205.png 768w\" sizes=\"(max-width: 1380px) 100vw, 1380px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-03df685 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"03df685\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u00bfPor qu\u00e9 necesitas este servicio?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6d8935f e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"6d8935f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-7db5242 e-con-full e-flex e-con e-child\" data-id=\"7db5242\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-263c846 elementor-widget elementor-widget-text-editor\" data-id=\"263c846\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Navigating Brazil\u2019s \"},{\"attributes\":{\"bold\":true},\"insert\":\"IVD regulatory framework requires accuracy, local expertise, and constant monitoring\"},{\"insert\":\" of Anvisa updates.\"}]\" data-inline-monday=\"true\">Navegar por el <strong>marco regulatorio del diagn\u00f3stico in vitro en Brasil requiere precisi\u00f3n, experiencia local<\/strong> y un seguimiento constante de las actualizaciones de Anvisa.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8acd2fa e-con-full e-flex e-con e-child\" data-id=\"8acd2fa\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ceb882c elementor-widget elementor-widget-text-editor\" data-id=\"ceb882c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"attributes\":{\"bold\":true},\"insert\":\"Mistakes \"},{\"insert\":\"in dossier preparation, missing documents, or delays in notification and registration \"},{\"attributes\":{\"bold\":true},\"insert\":\"can stall your launch.\"}]\" data-inline-monday=\"true\"><strong>Los errores<\/strong> en la preparaci\u00f3n del expediente, la falta de documentos o los retrasos en la notificaci\u00f3n y el registro <strong>pueden paralizar tu lanzamiento.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8be8199 e-con-full e-flex e-con e-child\" data-id=\"8be8199\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c5cc270 elementor-widget elementor-widget-text-editor\" data-id=\"c5cc270\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Without specialized support, it\u2019s easy to overlook new Anvisa rules or compliance standards, \"},{\"attributes\":{\"bold\":true},\"insert\":\"risking market entry.\"}]\" data-inline-monday=\"true\">Sin apoyo especializado, es f\u00e1cil pasar por alto las nuevas reglas de Anvisa o las normas de cumplimiento, <strong>arriesgando la entrada en el mercado.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-05707f3 e-flex e-con-boxed e-con e-parent\" data-id=\"05707f3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-a9c363e e-con-full e-flex e-con e-child\" data-id=\"a9c363e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e939e88 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"e939e88\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Tu camino hacia el registro y la notificaci\u00f3n de diagn\u00f3stico in vitro en Brasil<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c118750 e-con-full e-flex e-con e-child\" data-id=\"c118750\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a245111 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"a245111\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Sobel ofrece asistencia completa para la notificaci\u00f3n y el registro de diagn\u00f3stico in vitro conforme a las normas de clasificaci\u00f3n de Anvisa.<\/p><p><strong>Desde la preparaci\u00f3n del expediente y la revisi\u00f3n de documentos hasta el etiquetado, las IFU y el seguimiento estrat\u00e9gico, guiamos tu producto de diagn\u00f3stico in vitro sin problemas a trav\u00e9s de la aprobaci\u00f3n hasta la publicaci\u00f3n en el Diario Oficial (DOU).<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-efc5193 e-flex e-con-boxed e-con e-parent\" data-id=\"efc5193\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-565efad elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"565efad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Tu diagn\u00f3stico in vitro, listo para el mercado brasile\u00f1o.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0113a17 elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"0113a17\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ucaddon_horizontal_timeline.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n<!-- start Horizontal Timeline -->\n\t\t<link id='font-awesome-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-all.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='font-awesome-4-shim-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-v4-shims.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='owl-carousel-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/owl-carousel-new\/assets\/owl.carousel.css' type='text\/css' rel='stylesheet' >\n\n<style>\/* widget: Horizontal Timeline *\/\n\n#uc_horizontal_timeline_elementor_0113a17 *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_0113a17{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_0113a17 .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_0113a17 .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_0113a17  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_0113a17  .carousel-nav button i{\n  position: absolute;\n     top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%);\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_0113a17 .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-item-bullet i, #uc_horizontal_timeline_elementor_0113a17 .ue-item-bullet svg{\n  position: absolute;\n  top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%); \n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_0113a17 .ue-carousel-item-holder{\n  display: flex;\n  flex-direction: column;\n  align-items: stretch;\n  height:100%;\n}\n\n<\/style>\n\n<div class=\"ue-horizontal-timeline\" id=\"uc_horizontal_timeline_elementor_0113a17\">\n     <div class=\"carousel-nav\">\n            <button class=\"carousel-prev\" aria-label=\"Previous\">\n                <i class=' ti-arrow-circle-left'><\/i>\n            <\/button>\n            <button class=\"carousel-next\" aria-label=\"Next\">\n                <i class=' ti-arrow-circle-right'><\/i>\n            <\/button>\n        <\/div>\n    <div class=\"owl-carousel owl-theme uc-items-wrapper item-horizontal-timeline  \" id=\"uc_horizontal_timeline_elementor_0113a17\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-168780f\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Informaci\u00f3n sobre la empresa<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Facilitas los datos b\u00e1sicos de tu empresa para iniciar el proceso.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-306c4fb\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Comprobaci\u00f3n de la clasificaci\u00f3n de riesgos<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Confirmamos la clase de riesgo de tu diagn\u00f3stico in vitro (IVD) (I\u2013IV) para definir la v\u00eda regulatoria correcta.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-4ec4d19\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Lista de control personalizada<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Sobel prepara una lista de comprobaci\u00f3n completa con toda la documentaci\u00f3n exigida por Anvisa.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-bd4077d\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Revisi\u00f3n y preparaci\u00f3n<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Revisamos cr\u00edticamente tus documentos y preparamos materiales t\u00e9cnicos de acuerdo con la normativa brasile\u00f1a.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-8461409\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Presentaci\u00f3n y seguimiento<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Presentamos el expediente ante Anvisa y supervisamos cada paso hasta que se publica la aprobaci\u00f3n oficial en el Diario Oficial de la Uni\u00f3n (DOU).<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n\n  <\/div>\n<\/div>\n<!-- end Horizontal Timeline -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-adaecc5 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"adaecc5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">\u00a1Empieza ya!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9802be8 animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"9802be8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5628ca3 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"5628ca3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u00bfQu\u00e9 v\u00eda regulatoria se aplica a tu diagn\u00f3stico in vitro?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f80b566 elementor-widget elementor-widget-text-editor\" data-id=\"f80b566\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"attributes\":{\"comments\":[4429278731]},\"insert\":\"Anvisa classifies IVDs into different pathways depending on their risk and intended use:\"}]\" data-inline-monday=\"true\">Anvisa clasifica los productos de diagn\u00f3stico in vitro en diferentes v\u00edas en funci\u00f3n de su riesgo y uso previsto:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9060335 e-con-full e-flex e-con e-child\" data-id=\"9060335\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-517aa95 e-con-full e-flex e-con e-child\" data-id=\"517aa95\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5b9d6c1 elementor-widget elementor-widget-heading\" data-id=\"5b9d6c1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Notificaci\u00f3n<br>(Clase I y II):<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-98d9257 elementor-widget elementor-widget-text-editor\" data-id=\"98d9257\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Proceso simplificado para los productos de diagn\u00f3stico in vitro de bajo riesgo, como las tiras de orina o las pruebas de embarazo.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5649cb7 e-con-full e-flex e-con e-child\" data-id=\"5649cb7\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1b15396 elementor-widget elementor-widget-heading\" data-id=\"1b15396\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Registro (Clases III y IV):<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9026a7b elementor-widget elementor-widget-text-editor\" data-id=\"9026a7b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Aprobaci\u00f3n plena para diagn\u00f3sticos de mayor riesgo, como las pruebas del VIH o COVID-19.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-82e41e3 e-con-full e-flex e-con e-child\" data-id=\"82e41e3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-722fea9 elementor-widget elementor-widget-heading\" data-id=\"722fea9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Agrupaci\u00f3n familiar:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-19c5d1d elementor-widget elementor-widget-text-editor\" data-id=\"19c5d1d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Los productos similares con el mismo uso y tecnolog\u00eda pueden registrarse juntos.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fb20a06 e-con-full e-flex e-con e-child\" data-id=\"fb20a06\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a6eac00 elementor-widget elementor-widget-heading\" data-id=\"a6eac00\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Gesti\u00f3n del cambio:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-250aacf elementor-widget elementor-widget-text-editor\" data-id=\"250aacf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Cualquier actualizaci\u00f3n del etiquetado, los IFU o la fabricaci\u00f3n debe seguir los protocolos de Anvisa<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ee830d0 elementor-widget elementor-widget-text-editor\" data-id=\"ee830d0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"attributes\":{\"comments\":[4429278731]},\"insert\":\"From low-risk notifications to complex changes, Sobel helps you navigate every step of your IVD regulatory journey in Brazil.\"}]\" data-inline-monday=\"true\">Desde las notificaciones de bajo riesgo hasta los cambios complejos, Sobel te ayuda a navegar por cada paso de tu viaje regulatorio del diagn\u00f3stico in vitro en Brasil.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-848aab2 e-flex e-con-boxed e-con e-parent\" data-id=\"848aab2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-cb7a499 e-con-full e-flex e-con e-child\" data-id=\"cb7a499\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f51d717 elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"f51d717\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9178fb5 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"9178fb5\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Servicios relacionados <br><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3b3940b elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"3b3940b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span data-contrast=\"auto\">As\u00f3ciate con Sobel como tu representante brasile\u00f1o en Brasil para diagn\u00f3stico in vitro. Con Sobel, minimizas el riesgo, aseguras la alineaci\u00f3n regulatoria y posicionas tu producto de diagn\u00f3stico in vitro (IVD) para el \u00e9xito a largo plazo en Brasil. <\/span><span data-ccp-props=\"{}\"> <\/span><\/p><p><strong>Nosotros nos encargamos de la complejidad normativa, para que t\u00fa puedas centrarte en la innovaci\u00f3n.  <\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0e1f114 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"0e1f114\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-c4df77e e-con-full e-flex e-con e-child\" data-id=\"c4df77e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-875c509 elementor-widget elementor-widget-heading\" data-id=\"875c509\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Representante brasile\u00f1o en Brasil para diagn\u00f3stico in vitro<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e7a5854 elementor-widget elementor-widget-text-editor\" data-id=\"e7a5854\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"attributes\":{\"comments\":[4429265504]},\"insert\":\"Authorized legal representation for your IVDs in Brazil with Sobel. Compliance, vigilance and full support.\"}]\" data-inline-monday=\"true\">Representaci\u00f3n legal autorizada para tus productos de diagn\u00f3stico in vitro en Brasil con Sobel. Cumplimiento, vigilancia y apoyo total. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6a42201 elementor-widget elementor-widget-button\" data-id=\"6a42201\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/es\/nuestras-soluciones-diagnostico-in-vitro-div-ee-uu\/representante-brasileno-en-brasil-para-diagnostico-in-vitro\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Ver m\u00e1s<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f4038cf e-con-full e-flex e-con e-child\" data-id=\"f4038cf\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a756467 elementor-widget elementor-widget-heading\" data-id=\"a756467\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Gesti\u00f3n de la calidad\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8a1f61b elementor-widget elementor-widget-text-editor\" data-id=\"8a1f61b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p>Alinea tu SGC en Brasil con la ISO 13485 y la RDC 665\/2022.<\/p><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dd0fabe elementor-widget elementor-widget-button\" data-id=\"dd0fabe\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/qms-para-dispositivos-medicos-en-brasil\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Ver m\u00e1s<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b1d777c e-con-full e-flex e-con e-child\" data-id=\"b1d777c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c599135 elementor-widget elementor-widget-heading\" data-id=\"c599135\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Formaci\u00f3n reglamentaria<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a2edf1a elementor-widget elementor-widget-text-editor\" data-id=\"a2edf1a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Get support to meet Anvisa requirements with expert risk management services in Brazil for medical devices.\"}]\" data-inline-monday=\"true\">Programas de formaci\u00f3n de expertos sobre ISO 13485, MDSAP, ISO 10993 y los CDR de Anvisa.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6406220 elementor-widget elementor-widget-button\" data-id=\"6406220\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/capacitacion-regulatoria-para-dispositivos-medicos\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Ver m\u00e1s<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c1f4951 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"c1f4951\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-2cfb290 e-con-full e-flex e-con e-child\" data-id=\"2cfb290\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-be6532a e-con-full e-flex e-con e-child\" data-id=\"be6532a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c6c110a elementor-widget elementor-widget-heading\" data-id=\"c6c110a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Tu diagn\u00f3stico in vitro en el mercado brasile\u00f1o<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d6c51d5 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d6c51d5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Sobel te apoya en cada paso del proceso de registro y notificaci\u00f3n de diagn\u00f3stico in vitro. Desde la notificaci\u00f3n de Clase I hasta la aprobaci\u00f3n de Clase IV, te ayudamos a navegar por la complejidad normativa con claridad y confianza. <\/p><p><strong>\u00bfNecesitas asesoramiento experto para el registro y la notificaci\u00f3n de diagn\u00f3stico in vitro en Brasil? Ponte en contacto con nuestro equipo hoy mismo y da el primer paso hacia una aprobaci\u00f3n satisfactoria. <\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f74c17c elementor-align-center elementor-widget elementor-widget-button\" data-id=\"f74c17c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contacta con nosotros<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e79b47e e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"e79b47e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1a261cf elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"1a261cf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2741\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2741\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">\u00bfA\u00fan tienes preguntas? Consulta nuestras FAQ <\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2741\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2741\"><p><strong>1. \u00bfCu\u00e1l es la diferencia entre notificaci\u00f3n y registro de diagn\u00f3stico in vitro en Brasil?<\/strong><\/p>\n<p>El registro de diagn\u00f3stico in vitro en Brasil se basa en la clase de riesgo. El certificado de notificaci\u00f3n se aplica a los dispositivos de Clase I y II (bajo riesgo), siguiendo una v\u00eda simplificada. El registro completo es necesario para los dispositivos de diagn\u00f3stico in vitro de Clase III y IV, que implican m\u00e1s documentaci\u00f3n y datos cl\u00ednicos.  <\/p>\n<p><strong>2. \u00bfCu\u00e1nto tiempo se tarda en obtener una aprobaci\u00f3n de diagn\u00f3stico in vitro de Anvisa?<\/strong><\/p>\n<p>Los plazos var\u00edan: un certificado de notificaci\u00f3n puede expedirse en cuesti\u00f3n de semanas, mientras que un registro completo de diagn\u00f3stico in vitro en Brasil puede llevar varios meses, dependiendo de la calidad del expediente y de la carga de trabajo de revisi\u00f3n de Anvisa.<\/p>\n<p><strong>3. \u00bfPuede una empresa extranjera solicitar directamente el registro de diagn\u00f3stico in vitro en Brasil?<\/strong><\/p>\n<p>No. Los fabricantes extranjeros no pueden presentarse directamente a Anvisa. Deben trabajar con un socio local o una entidad autorizada para gestionar el registro y la notificaci\u00f3n de diagn\u00f3stico in vitro y mantener el cumplimiento en Brasil. Sobel puede actuar como tu <a href=\"https:\/\/sobelconsult.com\/es\/nuestras-soluciones-diagnostico-in-vitro-div-ee-uu\/representante-brasileno-en-brasil-para-diagnostico-in-vitro\/\" target=\"_blank\" rel=\"noopener\">representante brasile\u00f1o en Brasil para diagn\u00f3stico in vitro<\/a>, gestionando el registro y el cumplimiento continuo con Anvisa.   <\/p>\n<p><strong>4. \u00bfQu\u00e9 documentos se necesitan para el registro de diagn\u00f3stico in vitro en Anvisa?<\/strong><\/p>\n<p>Cada clasificaci\u00f3n de riesgo tiene su propio conjunto de documentos requeridos. Sobel proporciona orientaci\u00f3n experta sobre lo que se necesita para tu caso concreto y te apoya en la preparaci\u00f3n de cada paso de la presentaci\u00f3n. <\/p>\n<p><strong>5. \u00bfC\u00f3mo apoya Sobel el proceso de registro y notificaci\u00f3n de diagn\u00f3stico in vitro?<\/strong><\/p>\n<p>Sobel gu\u00eda a los fabricantes nacionales e internacionales en cada paso: clasificaci\u00f3n de riesgos, preparaci\u00f3n del expediente, presentaci\u00f3n a Anvisa y seguimiento hasta la aprobaci\u00f3n. Tanto si necesitas un certificado de notificaci\u00f3n como un registro completo de diagn\u00f3stico in vitro, Sobel garantiza el cumplimiento y acelera la entrada en el mercado brasile\u00f1o. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Apoyo experto para el registro y la notificaci\u00f3n de DIV en Brasil. 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