{"id":7894,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/servicio-de-reglamentacion-brasil\/"},"modified":"2026-04-10T10:49:00","modified_gmt":"2026-04-10T13:49:00","slug":"registro-y-notificacion-de-dispositivos-medicos-en-brasil","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\/","title":{"rendered":"Registro de productos sanitarios Anvisa | Apoyo reglamentario"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7894\" class=\"elementor elementor-7894 elementor-1676\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a3ca874 e-flex e-con-boxed e-con e-parent\" data-id=\"a3ca874\" 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-18f33cb elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"18f33cb\" 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 Dispositivos M\u00e9dicos 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-26c8e73 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"26c8e73\" 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\":\"Expanding your medical device business into Brazil represents a promising opportunity \u2014 but navigating Anvisa\u2019s regulatory system can be complex. At Sobel, we simplify this journey. Our team provides full regulatory support for Anvisa medical device registration, notification, change or rectification.\"}]\" data-inline-monday=\"true\">Expandir tu negocio de dispositivos m\u00e9dicos en Brasil representa una oportunidad prometedora, pero navegar por el sistema regulador de Anvisa puede ser complejo. En Sobel, simplificamos este proceso. Nuestro equipo proporciona apoyo regulatorio integral para el registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil, incluyendo cambios y rectificaciones ante 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-1011645 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"1011645\" 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-a0203dc e-flex e-con-boxed e-con e-parent\" data-id=\"a0203dc\" 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-9b16b0d e-con-full e-flex e-con e-child\" data-id=\"9b16b0d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-42d060f e-con-full e-transform e-flex e-con e-child\" data-id=\"42d060f\" 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-a97c56e elementor-widget elementor-widget-heading\" data-id=\"a97c56e\" 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-9bffa8e elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"9bffa8e\" 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-4ec7caf elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"4ec7caf\" 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\">Fabricantes extranjeros que ingresan por primera vez al mercado brasile\u00f1o.<\/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 locales responsables del registro o la notificaci\u00f3n 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 desean ampliar su cartera de productos bajo licencias existentes.<\/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\">Equipos regulatorios que requieren apoyo especializado con Anvisa.<\/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-8a2092b e-con-full e-flex e-con e-child\" data-id=\"8a2092b\" 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-caa49a1 elementor-widget elementor-widget-image\" data-id=\"caa49a1\" 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=\"755\" height=\"1024\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png\" class=\"attachment-large size-large wp-image-18567\" alt=\"A portable vital signs monitor sits on a table. Office supplies are also on the table. It looks like a doctor&#039;s office.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png 755w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-221x300.png 221w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-768x1041.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services.png 1011w\" sizes=\"(max-width: 755px) 100vw, 755px\" \/>\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-41dd92a e-flex e-con-boxed e-con e-parent\" data-id=\"41dd92a\" 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-460b27b elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"460b27b\" 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\":\"Whether your product requires notification or registration, Sobel provides end-to-end regulatory assistance.\"}]\" data-inline-monday=\"true\">Expande tu negocio de productos sanitarios en Brasil con confianza. Nuestro enfoque de registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil abarca todos los requisitos t\u00e9cnicos definidos por 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-61b552c elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"61b552c\" 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-ed56e84 e-flex e-con-boxed e-con e-parent\" data-id=\"ed56e84\" 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-0bca729 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"0bca729\" 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=\"1259\" height=\"275\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.png\" class=\"attachment-full size-full wp-image-18573\" alt=\"Vector rectangle blue\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.png 1259w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-300x66.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-1024x224.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-768x168.png 768w\" sizes=\"(max-width: 1259px) 100vw, 1259px\" \/>\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-17e3a7e elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"17e3a7e\" 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-9fa30b0 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"9fa30b0\" 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-0d72af0 e-con-full e-flex e-con e-child\" data-id=\"0d72af0\" 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-c9bf76b elementor-widget elementor-widget-text-editor\" data-id=\"c9bf76b\" 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\":\"The Brazilian regulatory pathway for medical devices involves detailed technical requirements and constant updates from Anvisa.\"}]\" data-inline-monday=\"true\">La v\u00eda regulatoria brasile\u00f1a para los productos sanitarios implica requisitos t\u00e9cnicos detallados y actualizaciones frecuentes emitidas por 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-46dd330 e-con-full e-flex e-con e-child\" data-id=\"46dd330\" 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-615f33d elementor-widget elementor-widget-text-editor\" data-id=\"615f33d\" 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 local expertise, companies often face long delays, repeated submissions, or even rejections that increase costs and postpone market entry.\"}]\" data-inline-monday=\"true\">Sin experiencia local, las empresas suelen enfrentarse a largos retrasos, presentaciones repetidas o incluso rechazos que incrementan los costes y retrasan la entrada al mercado.<\/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-2b6d8c1 e-con-full e-flex e-con e-child\" data-id=\"2b6d8c1\" 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-4da9700 elementor-widget elementor-widget-text-editor\" data-id=\"4da9700\" 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\":\"With Sobel\u2019s specialized support, your documentation is prepared according to the latest Anvisa framework (such as RDC 978\/2025 and RDC 658\/2022).\"}]\" data-inline-monday=\"true\">Con el acompa\u00f1amiento especializado de Sobel, tu estrategia de registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil se basa en el marco normativo m\u00e1s reciente, incluidas resoluciones como la RDC 978\/2025 y la RDC 658\/2022.<\/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-de34d2b e-flex e-con-boxed e-con e-parent\" data-id=\"de34d2b\" 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-84fbe12 e-con-full e-flex e-con e-child\" data-id=\"84fbe12\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d17acf1 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"d17acf1\" 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\">Requisitos de registro de productos m\u00e9dicos de Anvisa 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-121a488 e-con-full e-flex e-con e-child\" data-id=\"121a488\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0c6af99 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"0c6af99\" 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 class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Expand your medical device business into Brazil with confidence. Our process for Anvisa medical device registration covers every technical requirement defined by Anvisa. \"}]\" data-inline-monday=\"true\">El registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil requiere que los fabricantes clasifiquen el producto seg\u00fan su clase de riesgo, preparen la documentaci\u00f3n t\u00e9cnica conforme a la RDC 751\/2022 y resoluciones relacionadas, obtengan la certificaci\u00f3n de Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF) cuando corresponda y presenten los expedientes a trav\u00e9s del sistema electr\u00f3nico de Anvisa. Tambi\u00e9n es obligatorio mantener las actualizaciones regulatorias y el cumplimiento postcomercializaci\u00f3n para asegurar la continuidad de la comercializaci\u00f3n. <\/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-df60ede e-flex e-con-boxed e-con e-parent\" data-id=\"df60ede\" 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-3f228f8 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"3f228f8\" 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\">De la clasificaci\u00f3n del riesgo a la presentaci\u00f3n del expediente:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e6764e0 elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"e6764e0\" 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_e6764e0 *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_e6764e0 .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_e6764e0  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_e6764e0  .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_e6764e0 .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-item-bullet i, #uc_horizontal_timeline_elementor_e6764e0 .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_e6764e0 .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_e6764e0 .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_e6764e0\">\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_e6764e0\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-c73e9b6\">\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 de la documentaci\u00f3n<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Enviamos y validamos la lista de documentos exigidos por Anvisa seg\u00fan la categor\u00eda de tu producto.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-da7e74b\">\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 cr\u00edtica<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Nuestros especialistas realizan un an\u00e1lisis detallado de la documentaci\u00f3n presentada, identificando incoherencias o informaci\u00f3n faltante.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-990a85a\">\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=\"#\" >Preparaci\u00f3n del expediente<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Recopilamos formularios, declaraciones, certificados y documentaci\u00f3n t\u00e9cnica en el formato requerido por Anvisa.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-58fbbfd\">\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\">Nuestro equipo gestiona la presentaci\u00f3n del protocolo y la comunicaci\u00f3n con Anvisa hasta la aprobaci\u00f3n final del registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil.<\/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-be1edac elementor-align-center elementor-widget elementor-widget-button\" data-id=\"be1edac\" 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-baf207d animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"baf207d\" 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-9198c61 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"9198c61\" 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 servicio se aplica a tu caso?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aeb7c50 elementor-widget elementor-widget-text-editor\" data-id=\"aeb7c50\" 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\":\"Different regulatory paths exist within Anvisa medical device registration and notification. Understanding which one applies to your product is key to defining the correct strategy.\"}]\" data-inline-monday=\"true\">Existen diferentes v\u00edas regulatorias dentro del registro y la notificaci\u00f3n de productos sanitarios ante Anvisa. Comprender cu\u00e1l se aplica a tu producto es clave para definir la estrategia adecuada. <\/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-1a16004 e-flex e-con-boxed e-con e-child\" data-id=\"1a16004\" 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-1026174 e-con-full e-flex e-con e-child\" data-id=\"1026174\" 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-c2b2c39 elementor-widget elementor-widget-heading\" data-id=\"c2b2c39\" 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 de dispositivos m\u00e9dicos<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8d9854b elementor-widget elementor-widget-text-editor\" data-id=\"8d9854b\" 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\":\"For Class I and II devices (software, equipment, or material) that present low risk. Includes checklist review, document preparation, dossier submission, labeling, and follow-up until DOU publication.\"}]\" data-inline-monday=\"true\">Aplicable a dispositivos de clase I y II (software, equipos o materiales) considerados de bajo riesgo. Incluye revisi\u00f3n de la lista de verificaci\u00f3n, preparaci\u00f3n documental, presentaci\u00f3n del expediente, etiquetado y seguimiento hasta la publicaci\u00f3n en el DOU. <\/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-2553a4d e-con-full e-flex e-con e-child\" data-id=\"2553a4d\" 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-8388ac5 elementor-widget elementor-widget-heading\" data-id=\"8388ac5\" 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 de dispositivos m\u00e9dicos<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6dcde19 elementor-widget elementor-widget-text-editor\" data-id=\"6dcde19\" 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\":\"For Class III and IV devices (equipment, materials, and implantables) requiring full technical evaluation. Involves detailed dossier compilation, clinical and risk management documentation, and Anvisa petition submission.\"}]\" data-inline-monday=\"true\">Dirigido a dispositivos de clase III y IV (equipos, materiales e implantables) que requieren una evaluaci\u00f3n t\u00e9cnica completa. Implica la compilaci\u00f3n detallada del expediente, documentaci\u00f3n cl\u00ednica y de gesti\u00f3n de riesgos, y la presentaci\u00f3n formal ante 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-a7d78a9 e-con-full e-flex e-con e-child\" data-id=\"a7d78a9\" 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-5532bd3 elementor-widget elementor-widget-heading\" data-id=\"5532bd3\" 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 o cambio de registro<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ad53e8b elementor-widget elementor-widget-text-editor\" data-id=\"ad53e8b\" 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\":\"When an already approved product undergoes updates (e.g., design, labeling, or manufacturing). Covers amendment documentation, new comparative tables, and re-submission to Anvisa for approval.\"}]\" data-inline-monday=\"true\">Aplicable cuando un producto aprobado sufre modificaciones (por ejemplo, dise\u00f1o, etiquetado o fabricaci\u00f3n). Incluye documentaci\u00f3n de cambio, tablas comparativas y nueva presentaci\u00f3n ante 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-200d2ba e-con-full e-flex e-con e-child\" data-id=\"200d2ba\" 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-b3cc782 elementor-widget elementor-widget-heading\" data-id=\"b3cc782\" 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\">Rectificaci\u00f3n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8e6ed03 elementor-widget elementor-widget-text-editor\" data-id=\"8e6ed03\" 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\":\"When Anvisa requests corrections after submission. Focused on form correction, test guidance, and follow-up until closure of the agency\u2019s request.\"}]\" data-inline-monday=\"true\">Se aplica cuando Anvisa solicita correcciones tras la revisi\u00f3n del expediente. Se centra en la correcci\u00f3n de formularios, orientaci\u00f3n sobre pruebas adicionales y seguimiento hasta el cierre del requerimiento. <\/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\t\t<div class=\"elementor-element elementor-element-8a4cd99 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"8a4cd99\" 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\">\u00bfNo sabes c\u00f3mo registrar tu producto sanitario ante Anvisa?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5e551ff elementor-widget elementor-widget-text-editor\" data-id=\"5e551ff\" 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\":\"Sobel\u2019s regulatory consultants will assess your current documentation and determine whether your device requires notification, registration, or a change process!\"}]\" data-inline-monday=\"true\">Los asesores regulatorios de Sobel evaluar\u00e1n tu documentaci\u00f3n actual y determinar\u00e1n si tu dispositivo requiere notificaci\u00f3n, registro o un proceso de cambio.<\/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-0551810 e-flex e-con-boxed e-con e-parent\" data-id=\"0551810\" 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-41b7d9f e-con-full e-flex e-con e-child\" data-id=\"41b7d9f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c99d7f1 elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"c99d7f1\" 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-f00c36f elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"f00c36f\" 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-c4bc05f elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"c4bc05f\" 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 class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"At Sobel, we guide companies through the complete process of Anvisa medical device registration and notification. Explore other Sobel solutions that complement this service:\"}]\" data-inline-monday=\"true\">En Sobel, guiamos a las empresas a trav\u00e9s de <a href=\"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/\" target=\"_blank\" rel=\"noopener\">todo el proceso regulatorio ante Anvisa<\/a>. Tambi\u00e9n puedes complementar este servicio con: <\/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-d40035c e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"d40035c\" 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-436ce6a e-con-full e-flex e-con e-child\" data-id=\"436ce6a\" 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-bd03b65 elementor-widget elementor-widget-heading\" data-id=\"bd03b65\" 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\"><a href=\"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/qms-para-dispositivos-medicos-en-brasil\/\" target=\"_blank\">Gesti\u00f3n de la calidad<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2a6e53a elementor-widget elementor-widget-text-editor\" data-id=\"2a6e53a\" 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\":\"Align your QMS in Brazil with ISO 13485 and RDC 665\/2022.\"}]\" data-inline-monday=\"true\">Alinea tu SGC en Brasil con la ISO 13485 y la RDC 665\/2022.<\/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-f436e6c elementor-align-center elementor-widget elementor-widget-button\" data-id=\"f436e6c\" 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-15826d9 e-con-full e-flex e-con e-child\" data-id=\"15826d9\" 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-8b372ad elementor-widget elementor-widget-heading\" data-id=\"8b372ad\" 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\"><a href=\"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/biological-evaluation-brazil\/\" target=\"_blank\">Evaluaci\u00f3n biol\u00f3gica<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2847c56 elementor-widget elementor-widget-text-editor\" data-id=\"2847c56\" 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\"><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 class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Biological evaluation in line with ISO 10993 and Anvisa requirements.\"}]\" data-inline-monday=\"true\">Evaluaci\u00f3n biol\u00f3gica conforme a la norma ISO 10993 y los requisitos de Anvisa.<\/p><\/div><\/div><\/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-a362d80 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"a362d80\" 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\/biological-evaluation-brazil\/\" 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-3887dd6 e-con-full e-flex e-con e-child\" data-id=\"3887dd6\" 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-a1d0f67 elementor-widget elementor-widget-heading\" data-id=\"a1d0f67\" 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\"><a href=\"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/representante-legal-en-brasil-para-dispositivos-medicos\/\" target=\"_blank\">Titular de registro brasile\u00f1o<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-84eaa63 elementor-widget elementor-widget-text-editor\" data-id=\"84eaa63\" 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\":\"Navigate market access in Brazil with Sobel as your device registration holder.\"}]\" data-inline-monday=\"true\">Acceso al mercado en Brasil con Sobel como titular del registro de tu dispositivo.<\/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-fc6315b elementor-align-center elementor-widget elementor-widget-button\" data-id=\"fc6315b\" 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\/representante-legal-en-brasil-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-ac1f100 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"ac1f100\" 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-d39e089 e-con-full e-flex e-con e-child\" data-id=\"d39e089\" 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-29bc0ca e-con-full e-flex e-con e-child\" data-id=\"29bc0ca\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9de714c elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"9de714c\" 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\">Una entrada al mercado conforme con Sobel<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe8dfc9 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"fe8dfc9\" 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>Obtener un registro o notificaci\u00f3n ante Anvisa es m\u00e1s que un tr\u00e1mite administrativo: es un paso estrat\u00e9gico para un acceso sostenible al mercado brasile\u00f1o.<\/p><p>Con un equipo especializado en Anvisa y un profundo conocimiento de la legislaci\u00f3n local, Sobel ofrece claridad, rigor t\u00e9cnico y un seguimiento confiable en cada etapa.<\/p><p><strong>\u00a1Da el primer paso hacia un proceso regulatorio sin contratiempos!<\/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-d726016 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"d726016\" 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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3968e60 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"3968e60\" 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-c78715e elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"c78715e\" 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-2091\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2091\" 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-2091\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2091\"><p><b>1. \u00bfQu\u00e9 es el registro o notificaci\u00f3n de productos sanitarios de Anvisa?<\/b><\/p>\n<p>Es el proceso normativo exigido por la Agencia Brasile\u00f1a de Regulaci\u00f3n Sanitaria (Anvisa) para autorizar la comercializaci\u00f3n de productos sanitarios en Brasil. Todos los productos deben cumplir las resoluciones aplicables, como la RDC 978\/2025 y la RDC 658\/2022, que definen los criterios de clasificaci\u00f3n, la documentaci\u00f3n y las etapas de evaluaci\u00f3n t\u00e9cnica. <\/p>\n<p><b>2. \u00bfCu\u00e1l es la diferencia entre notificaci\u00f3n y registro en Anvisa?<\/b><\/p>\n<p>La notificaci\u00f3n se aplica a los dispositivos de clase I y II, considerados de riesgo bajo a medio. El proceso es simplificado y m\u00e1s r\u00e1pido. El registro se aplica a los dispositivos de Clase III y IV, que requieren una evaluaci\u00f3n t\u00e9cnica y cl\u00ednica detallada antes de su aprobaci\u00f3n. Sobel te ayuda a determinar qu\u00e9 v\u00eda se aplica a tu producto y a evaluar la v\u00eda reglamentaria.   <\/p>\n<p><b>3. \u00bfC\u00f3mo registro un producto sanitario en Anvisa?<\/b><\/p>\n<p>Para saber c\u00f3mo registrar tu producto en Anvisa, el proceso comienza con la clasificaci\u00f3n del dispositivo, la preparaci\u00f3n del expediente y la presentaci\u00f3n a trav\u00e9s del sistema Anvisa (Solicita). Los documentos requeridos incluyen descripciones t\u00e9cnicas, an\u00e1lisis de riesgos, \u00a1y mucho m\u00e1s! Sobel gestiona todo el proceso de presentaci\u00f3n, seguimiento y publicaci\u00f3n para que el registro en Anvisa sea eficaz y conforme a las normas.  <\/p>\n<p><b>4. \u00bfQu\u00e9 es el AFE y por qu\u00e9 lo necesito?<\/b><\/p>\n<p>La Anvisa AFE (Autoriza\u00e7\u00e3o de Funcionamento de Empresa) es la licencia de empresa necesaria antes del registro de cualquier producto. Sin ella, los fabricantes o importadores no pueden operar legalmente en el mercado sanitario brasile\u00f1o. <\/p>\n<p><b>5. \u00bfCu\u00e1nto tarda el registro en Anvisa?<\/b><\/p>\n<p>El tiempo de procesamiento depende de la clase de dispositivo y de la cola actual de Anvisa. El seguimiento proactivo de Sobel ayuda a reducir los posibles retrasos y a mantener la alineaci\u00f3n de los documentos. <\/p>\n<p><b>6. Mi inscripci\u00f3n ya est\u00e1 aprobada. \u00bfCu\u00e1ndo debo solicitar un cambio o rectificaci\u00f3n? <\/b><\/p>\n<p>Se requiere una modificaci\u00f3n cuando se actualizan las caracter\u00edsticas del producto, como el etiquetado, el dise\u00f1o o el lugar de fabricaci\u00f3n. Una rectificaci\u00f3n se aplica cuando Anvisa identifica problemas formales durante la revisi\u00f3n y solicita correcciones. Sobel soporta tanto los cambios de notificaci\u00f3n y registro como las rectificaciones de producto, gestionando la comunicaci\u00f3n con la agencia hasta su aprobaci\u00f3n.  <\/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>Registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil. Sobel apoya la presentaci\u00f3n de expedientes ante Anvisa. <\/p>\n","protected":false},"author":16,"featured_media":7227,"parent":8383,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-7894","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil<\/title>\n<meta name=\"description\" content=\"Registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil. Sobel apoya la presentaci\u00f3n de expedientes ante Anvisa.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Registro de productos sanitarios Anvisa | Apoyo reglamentario\" \/>\n<meta property=\"og:description\" content=\"Registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil. Sobel apoya la presentaci\u00f3n de expedientes ante Anvisa.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-10T13:49:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-Support.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"657\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data1\" content=\"6 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/our-solutions-brazil\\\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\\\/\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/our-solutions-brazil\\\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\\\/\",\"name\":\"Registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/our-solutions-brazil\\\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/our-solutions-brazil\\\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2025\\\/04\\\/Regulatory-Support.webp\",\"datePublished\":\"2025-06-01T13:00:00+00:00\",\"dateModified\":\"2026-04-10T13:49:00+00:00\",\"description\":\"Registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil. Sobel apoya la presentaci\u00f3n de expedientes ante Anvisa.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/our-solutions-brazil\\\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\\\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/sobelconsult.com\\\/es\\\/our-solutions-brazil\\\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/our-solutions-brazil\\\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\\\/#primaryimage\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2025\\\/04\\\/Regulatory-Support.webp\",\"contentUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2025\\\/04\\\/Regulatory-Support.webp\",\"width\":1000,\"height\":657,\"caption\":\"Businessman checking documents at table\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/our-solutions-brazil\\\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Inicio\",\"item\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/home\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Nuestras soluciones Brasil\",\"item\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/our-solutions-brazil\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Registro de productos sanitarios Anvisa | Apoyo reglamentario\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/#website\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/\",\"name\":\"Sobel\",\"description\":\"Regulatory Consultancy\",\"publisher\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/#organization\",\"name\":\"Sobel\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2024\\\/07\\\/Logo-Oficial-Website-White.png\",\"contentUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2024\\\/07\\\/Logo-Oficial-Website-White.png\",\"width\":741,\"height\":290,\"caption\":\"Sobel\"},\"image\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil","description":"Registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil. Sobel apoya la presentaci\u00f3n de expedientes ante Anvisa.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\/","og_locale":"es_ES","og_type":"article","og_title":"Registro de productos sanitarios Anvisa | Apoyo reglamentario","og_description":"Registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil. Sobel apoya la presentaci\u00f3n de expedientes ante Anvisa.","og_url":"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\/","og_site_name":"Sobel","article_modified_time":"2026-04-10T13:49:00+00:00","og_image":[{"width":1000,"height":657,"url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-Support.webp","type":"image\/webp"}],"twitter_card":"summary_large_image","twitter_misc":{"Tiempo de lectura":"6 minuto"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\/","url":"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\/","name":"Registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil","isPartOf":{"@id":"https:\/\/sobelconsult.com\/es\/#website"},"primaryImageOfPage":{"@id":"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\/#primaryimage"},"image":{"@id":"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\/#primaryimage"},"thumbnailUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-Support.webp","datePublished":"2025-06-01T13:00:00+00:00","dateModified":"2026-04-10T13:49:00+00:00","description":"Registro y notificaci\u00f3n de dispositivos m\u00e9dicos en Brasil. Sobel apoya la presentaci\u00f3n de expedientes ante Anvisa.","breadcrumb":{"@id":"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\/#primaryimage","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-Support.webp","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-Support.webp","width":1000,"height":657,"caption":"Businessman checking documents at table"},{"@type":"BreadcrumbList","@id":"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/registro-y-notificacion-de-dispositivos-medicos-en-brasil\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Inicio","item":"https:\/\/sobelconsult.com\/es\/home\/"},{"@type":"ListItem","position":2,"name":"Nuestras soluciones Brasil","item":"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/"},{"@type":"ListItem","position":3,"name":"Registro de productos sanitarios Anvisa | Apoyo reglamentario"}]},{"@type":"WebSite","@id":"https:\/\/sobelconsult.com\/es\/#website","url":"https:\/\/sobelconsult.com\/es\/","name":"Sobel","description":"Regulatory Consultancy","publisher":{"@id":"https:\/\/sobelconsult.com\/es\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/sobelconsult.com\/es\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/sobelconsult.com\/es\/#organization","name":"Sobel","url":"https:\/\/sobelconsult.com\/es\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/sobelconsult.com\/es\/#\/schema\/logo\/image\/","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png","width":741,"height":290,"caption":"Sobel"},"image":{"@id":"https:\/\/sobelconsult.com\/es\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages\/7894","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/comments?post=7894"}],"version-history":[{"count":14,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages\/7894\/revisions"}],"predecessor-version":[{"id":33960,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages\/7894\/revisions\/33960"}],"up":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages\/8383"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/media\/7227"}],"wp:attachment":[{"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/media?parent=7894"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}