{"id":11753,"date":"2025-08-08T16:40:54","date_gmt":"2025-08-08T19:40:54","guid":{"rendered":"https:\/\/sobelconsult.com\/representant-bresilien-ivd-2\/"},"modified":"2026-02-11T11:01:19","modified_gmt":"2026-02-11T14:01:19","slug":"brazilian-representative-ivd","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/fr\/nos-solutions-diagnostic-in-vitro-div-etats-unis\/brazilian-representative-ivd\/","title":{"rendered":"Repr\u00e9sentant br\u00e9silien IVD"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"11753\" class=\"elementor elementor-11753 elementor-11746\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e41ca2e e-flex e-con-boxed e-con e-parent\" data-id=\"e41ca2e\" 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-c706974 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"c706974\" 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\">Repr\u00e9sentant br\u00e9silien IVD<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-afd8df1 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"afd8df1\" 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\":\"Entering the Brazilian market with your IVD device? You\u2019ll need need a trusted Legal Representative in Brazil. With Sobel as your partner, you simplify the process without risking compliance.\"}]\" data-inline-monday=\"true\">Vous souhaitez p\u00e9n\u00e9trer le march\u00e9 br\u00e9silien avec votre dispositif de diagnostic in vitro ? Vous aurez besoin d&rsquo;un repr\u00e9sentant l\u00e9gal de confiance au Br\u00e9sil.  Avec Sobel comme partenaire, vous simplifiez le processus sans risquer la conformit\u00e9.<\/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-da0e756 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"da0e756\" 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%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%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\">Obtenez l'aide d'un expert<\/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-efd54a3 animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"efd54a3\" 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-40d2678 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"40d2678\" 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\">Soutien sp\u00e9cialis\u00e9 pour la conformit\u00e9 r\u00e9glementaire des DIV au Br\u00e9sil  <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f4e82c6 elementor-widget elementor-widget-text-editor\" data-id=\"f4e82c6\" 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><span class=\"TextRun SCXW182009399 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW182009399 BCX0\">Les fabricants internationaux de dispositifs m\u00e9dicaux de diagnostic in vitro (DIV) doivent d\u00e9signer une entit\u00e9 locale pour agir en leur nom avant que l <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW182009399 BCX0\">Anvisa<\/span><span class=\"NormalTextRun SCXW182009399 BCX0\">. <\/span><span class=\"NormalTextRun SCXW182009399 BCX0\">Il s&rsquo;agit d&rsquo;une<\/span><span class=\"NormalTextRun SCXW182009399 BCX0\"> une exigence l\u00e9gale qui a un <\/span><span class=\"NormalTextRun SCXW182009399 BCX0\">directement<\/span><span class=\"NormalTextRun SCXW182009399 BCX0\"> votre capacit\u00e9 \u00e0 vous enregistrer et \u00e0 <\/span><span class=\"NormalTextRun SCXW182009399 BCX0\">maintenir<\/span><span class=\"NormalTextRun SCXW182009399 BCX0\"> votre produit DIV au Br\u00e9sil.<\/span><\/span><span class=\"EOP SCXW182009399 BCX0\" data-ccp-props=\"{}\"> <\/span><\/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-6651a5a e-flex e-con-boxed e-con e-parent\" data-id=\"6651a5a\" 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-8bc2b6d e-con-full e-flex e-con e-child\" data-id=\"8bc2b6d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-1241a3b e-con-full e-transform e-flex e-con e-child\" data-id=\"1241a3b\" 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-504a1cb elementor-widget elementor-widget-heading\" data-id=\"504a1cb\" 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\">Pour qui ?<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-de16d78 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"de16d78\" 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-c168ebe elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"c168ebe\" 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\">Pour les fabricants et les distributeurs qui ont besoin d'une repr\u00e9sentation experte pour les DIV au Br\u00e9sil.<\/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\">Les fabricants internationaux de DIV, qui exigent qu'une entit\u00e9 locale enregistre et conserve les produits aupr\u00e8s de l'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\">Les entreprises \u00e9trang\u00e8res qui ont besoin d'une repr\u00e9sentation officielle pour r\u00e9pondre aux exigences r\u00e9glementaires br\u00e9siliennes.  <\/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\">Les marques internationales qui cherchent \u00e0 \u00e9tablir et \u00e0 maintenir leur pr\u00e9sence sur le march\u00e9 br\u00e9silien par le biais d'une repr\u00e9sentation locale.  <\/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-312f19b e-con-full e-flex e-con e-child\" data-id=\"312f19b\" 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-1ba7088 elementor-widget elementor-widget-image\" data-id=\"1ba7088\" 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-12403\" 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-a66e4c8 e-flex e-con-boxed e-con e-parent\" data-id=\"a66e4c8\" 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-b9fb655 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"b9fb655\" 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><span class=\"TextRun SCXW85963229 BCX0\" lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW85963229 BCX0\">L&rsquo;\u00e9quipe exp\u00e9riment\u00e9e de Sobel vous aide \u00e0 respecter ces obligations avec pr\u00e9cision, ce qui vous permet d&rsquo;\u00e9largir votre entr\u00e9e sur le march\u00e9 sans <\/span><\/span><span class=\"TextRun SCXW85963229 BCX0\" lang=\"PT-BR\" data-contrast=\"auto\"><span class=\"NormalTextRun SpellingErrorV2Themed SCXW85963229 BCX0\">perturbation<\/span><\/span><span class=\"TextRun SCXW85963229 BCX0\" lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW85963229 BCX0\">.<\/span><\/span><span class=\"EOP SCXW85963229 BCX0\" data-ccp-props=\"{}\"> <\/span><\/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-01019a1 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"01019a1\" 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%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%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\">Obtenez de l'aide !<\/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-ab5768d e-flex e-con-boxed e-con e-parent\" data-id=\"ab5768d\" 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-b8ae9a7 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"b8ae9a7\" 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-10620\" 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-295b332 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"295b332\" 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\">Pourquoi avez-vous besoin de ce service ?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c80ec2b e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"c80ec2b\" 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-4b1cb95 e-con-full e-flex e-con e-child\" data-id=\"4b1cb95\" 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-1b82e93 elementor-widget elementor-widget-text-editor\" data-id=\"1b82e93\" 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\":\"Appointing a Legal Representative for IVD registration in Brazil is not optional, it\u2019s a regulatory necessity.\"}]\" data-inline-monday=\"true\"><span class=\"TextRun SCXW137021448 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW137021448 BCX0\">La d\u00e9signation d&rsquo;un repr\u00e9sentant l\u00e9gal pour l&rsquo;enregistrement des DIV au Br\u00e9sil n&rsquo;est pas facultative, <\/span><strong><span class=\"NormalTextRun SCXW137021448 BCX0\">c&rsquo;est<\/span><span class=\"NormalTextRun SCXW137021448 BCX0\"> une n\u00e9cessit\u00e9 r\u00e9glementaire.<\/span><\/strong><\/span><strong><span class=\"EOP SCXW137021448 BCX0\" data-ccp-props=\"{}\"> <\/span><\/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-d5fb050 e-con-full e-flex e-con e-child\" data-id=\"d5fb050\" 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-7860896 elementor-widget elementor-widget-text-editor\" data-id=\"7860896\" 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><span class=\"TextRun SCXW220562317 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW220562317 BCX0\">Sans entit\u00e9 juridique reconnue, votre dispositif m\u00e9dical de diagnostic in vitro ne peut \u00eatre <strong>\u00e9valu\u00e9 ou approuv\u00e9 par <\/strong><\/span><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW220562317 BCX0\">Anvisa<\/span><span class=\"NormalTextRun SCXW220562317 BCX0\">. <\/span><\/strong> <\/span><strong><span class=\"EOP SCXW220562317 BCX0\" data-ccp-props=\"{}\"> <\/span><\/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-7c0d19a e-con-full e-flex e-con e-child\" data-id=\"7c0d19a\" 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-93a2492 elementor-widget elementor-widget-text-editor\" data-id=\"93a2492\" 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\":\"Furthermore, Brazil\u2019s regulatory system requires a local contact for ongoing obligations like vigilance, distributor updates, and agency communications.\"}]\" data-inline-monday=\"true\"><span class=\"TextRun SCXW210746095 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW210746095 BCX0\">En outre, le syst\u00e8me r\u00e9glementaire br\u00e9silien exige un contact local pour les obligations permanentes <strong>telles que la vigilance, les mises \u00e0 jour des distributeurs et les communications de l&rsquo;agence.<\/strong><\/span><\/span><strong><span class=\"EOP SCXW210746095 BCX0\" data-ccp-props=\"{}\"> <\/span><\/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-b3eca14 e-flex e-con-boxed e-con e-parent\" data-id=\"b3eca14\" 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-0969a1f e-con-full e-flex e-con e-child\" data-id=\"0969a1f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-21bed6a elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"21bed6a\" 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\">Votre parcours vers l'approbation Anvisa pour les DIV  <\/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-626e43b e-con-full e-flex e-con e-child\" data-id=\"626e43b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-91895e1 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"91895e1\" 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\">Sobel est votre repr\u00e9sentant local au Br\u00e9sil, officiellement reconnu par l&rsquo;Anvisa pour repr\u00e9senter vos dispositifs m\u00e9dicaux de diagnostic in vitro.  <\/span><span data-ccp-props=\"{}\"> <\/span><\/p><p><strong>Notre support local aide \u00e0 combler le foss\u00e9 entre vos op\u00e9rations globales et les exigences d&rsquo;Anvisa.  <\/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-5c82916 e-flex e-con-boxed e-con e-parent\" data-id=\"5c82916\" 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-e9c4807 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"e9c4807\" 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\">Avec Sobel, votre produit b\u00e9n\u00e9ficie d'une pr\u00e9sence locale r\u00e9active, conforme et exp\u00e9riment\u00e9e - un pilier essentiel pour r\u00e9ussir au Br\u00e9sil.  <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3ec384b elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"3ec384b\" 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_3ec384b *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_3ec384b .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_3ec384b .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_3ec384b  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_3ec384b  .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_3ec384b .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_3ec384b .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-item-bullet i, #uc_horizontal_timeline_elementor_3ec384b .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_3ec384b .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_3ec384b .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_3ec384b\">\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_3ec384b\" 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=\"#\" >Nomination officielle<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Vous nous fournissez les coordonn\u00e9es de votre entreprise et nous pr\u00e9parons le contrat et la lettre de d\u00e9signation, d\u00e9signant officiellement Sobel comme votre repr\u00e9sentant br\u00e9silien.<\/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=\"#\" >Reconnaissance avec Anvisa<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">\u00c0 partir de ce moment, nous agissons en tant que contact juridique de votre entreprise aupr\u00e8s de l'Anvisa, repr\u00e9sentant officiellement vos int\u00e9r\u00eats au Br\u00e9sil.<\/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=\"#\" >Gestion continue<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Avec Sobel, vous disposez d'une structure fiable pour g\u00e9rer la surveillance post-commercialisation, la qualification des distributeurs et toute la communication n\u00e9cessaire avec 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=\"#\" >Soutien tout au long du cycle de vie<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Tant que vos produits restent sur le march\u00e9 br\u00e9silien, vous pouvez compter sur notre soutien r\u00e9glementaire pour maintenir la conformit\u00e9 sans avoir besoin de votre propre structure locale.<\/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-6b5a7d4 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"6b5a7d4\" 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%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%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\">Commencez d\u00e8s maintenant !<\/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-1ad10d5f e-flex e-con-boxed e-con e-parent\" data-id=\"1ad10d5f\" 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-4e2ec63f e-con-full e-flex e-con e-child\" data-id=\"4e2ec63f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5ad6a62e elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"5ad6a62e\" 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-7acfc1b6 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"7acfc1b6\" 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\">Services connexes <br><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5a510ab6 elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"5a510ab6\" 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>Pour vous aider dans votre d\u00e9marche de DIV au Br\u00e9sil, Sobel propose d&rsquo;<strong>autres services strat\u00e9giques <\/strong>qui peuvent s&rsquo;av\u00e9rer pertinents pour votre projet.<\/p><p>Nous travaillons \u00e9galement avec des dispositifs m\u00e9dicaux, et certains de ces services s&rsquo;appliquent aux deux cat\u00e9gories :<\/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-1307f21c e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"1307f21c\" 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-aa88814 e-con-full e-flex e-con e-child\" data-id=\"aa88814\" 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-e763e7e elementor-widget elementor-widget-heading\" data-id=\"e763e7e\" 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\">Notification et enregistrement des DIV<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b541d1f elementor-widget elementor-widget-text-editor\" data-id=\"b541d1f\" 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\":\"Register your IVD in Brazil with expert support from Sobel. We assist with Anvisa submission, documentation, classification and more.\"}]\" data-inline-monday=\"true\">Enregistrez votre DIV au Br\u00e9sil avec l&rsquo;aide des experts de Sobel. Nous vous assistons dans la soumission d&rsquo;Anvisa, la documentation, la classification et plus encore. <\/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-8b273db elementor-widget elementor-widget-button\" data-id=\"8b273db\" 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\/fr\/nos-solutions-diagnostic-in-vitro-div-etats-unis\/brazil-ivd-registration-full-regulatory-support\/\" 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\">Voir plus<\/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-129079b e-con-full e-flex e-con e-child\" data-id=\"129079b\" 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-3a1cdcb elementor-widget elementor-widget-heading\" data-id=\"3a1cdcb\" 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\">Formation r\u00e9glementaire\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0085f85 elementor-widget elementor-widget-text-editor\" data-id=\"0085f85\" 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>Programmes de formation d&rsquo;experts sur les normes ISO 13485, MDSAP, ISO 10993 et les CDR d&rsquo;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-43fd40f elementor-widget elementor-widget-button\" data-id=\"43fd40f\" 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\/fr\/our-solutions-brazil\/regulatory-training-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\">Voir plus<\/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-ba582a4 e-con-full e-flex e-con e-child\" data-id=\"ba582a4\" 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-cbc6519 elementor-widget elementor-widget-heading\" data-id=\"cbc6519\" 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\">Gestion de la qualit\u00e9<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-89891df elementor-widget elementor-widget-text-editor\" data-id=\"89891df\" 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\">Alignez votre SMQ au Br\u00e9sil sur les normes ISO 13485 et 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-2aea00d elementor-widget elementor-widget-button\" data-id=\"2aea00d\" 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\/fr\/our-solutions-brazil\/quality-management-system-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\">Voir plus<\/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-873f375 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"873f375\" 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-162df39 e-con-full e-flex e-con e-child\" data-id=\"162df39\" 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-e7681ee e-con-full e-flex e-con e-child\" data-id=\"e7681ee\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bd3d489 elementor-widget elementor-widget-heading\" data-id=\"bd3d489\" 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\">Pr\u00eat \u00e0 entrer sur le march\u00e9 br\u00e9silien des tests de diagnostic in vitro en toute confiance ?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-babd41c elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"babd41c\" 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>Faites de Sobel votre repr\u00e9sentant autoris\u00e9 au Br\u00e9sil. Avec Sobel, vous minimisez les risques, vous assurez l&rsquo;alignement r\u00e9glementaire et vous positionnez votre produit DIV pour un succ\u00e8s \u00e0 long terme au Br\u00e9sil. <\/p><p><strong>Nous nous chargeons de la complexit\u00e9 r\u00e9glementaire, afin que vous puissiez vous concentrer sur l&rsquo;innovation.<\/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-a7f1d93 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"a7f1d93\" 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=\"#our-services\">\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\">Commencez d\u00e8s maintenant !<\/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-5fe6595 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"5fe6595\" 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-a74acf3 elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"a74acf3\" 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-1751\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1751\" 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\">Vous avez encore des questions ? Consultez notre FAQ <\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1751\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1751\"><p><strong>1. Qu&rsquo;est-ce qu&rsquo;un repr\u00e9sentant l\u00e9gal dans le contexte de la r\u00e9glementation br\u00e9silienne ?<\/strong>  Un repr\u00e9sentant l\u00e9gal est une entit\u00e9 locale officiellement d\u00e9sign\u00e9e pour agir au nom d&rsquo;un fabricant \u00e9tranger de DIV aupr\u00e8s de l&rsquo;Anvisa, l&rsquo;agence br\u00e9silienne de r\u00e9glementation de la sant\u00e9. Ce repr\u00e9sentant est charg\u00e9 de g\u00e9rer le processus r\u00e9glementaire du produit et de veiller au respect des exigences nationales. <\/p>\n<p><strong>2. Un repr\u00e9sentant l\u00e9gal est-il obligatoire pour l&rsquo;enregistrement des DIV au Br\u00e9sil ?<\/strong>  Oui. La d\u00e9signation d&rsquo;un repr\u00e9sentant l\u00e9gal au Br\u00e9sil est une obligation l\u00e9gale. Sans entit\u00e9 locale d\u00e9sign\u00e9e, votre produit DIV ne peut \u00eatre enregistr\u00e9, \u00e9valu\u00e9 ou approuv\u00e9 par Anvisa.  <\/p>\n<p><strong>3. Le repr\u00e9sentant l\u00e9gal peut-il \u00eatre diff\u00e9rent du distributeur ?<\/strong>  Tout \u00e0 fait. En fait, la d\u00e9signation d&rsquo;un repr\u00e9sentant juridique ind\u00e9pendant - distinct du distributeur - permet au fabricant de mieux contr\u00f4ler les questions r\u00e9glementaires et de travailler avec plusieurs distributeurs. <\/p>\n<p><strong>4. Quelles sont les responsabilit\u00e9s du repr\u00e9sentant l\u00e9gal ?<\/strong> Le repr\u00e9sentant juridique s&rsquo;occupe de toutes les communications r\u00e9glementaires avec Anvisa, y compris :<\/p>\n<p>- Soumettre et maintenir les enregistrements de produits<\/p>\n<p>- D\u00e9tenir la documentation technique localement (dossier technique)<\/p>\n<p>- G\u00e9rer la vigilance et les rapports d&rsquo;\u00e9v\u00e9nements ind\u00e9sirables<\/p>\n<p>- Soutenir la qualification et les mises \u00e0 jour des distributeurs<\/p>\n<p>- Agir en tant que point de contact officiel pour les inspections ou les audits.<\/p>\n<p><strong>5. Comment le repr\u00e9sentant l\u00e9gal est-il officiellement d\u00e9sign\u00e9 ?<\/strong>  La nomination se fait au moyen d&rsquo;une procuration sign\u00e9e par le fabricant et l\u00e9galis\u00e9e pour \u00eatre utilis\u00e9e au Br\u00e9sil. Ce document autorise le repr\u00e9sentant \u00e0 agir au nom du fabricant pour toutes les questions r\u00e9glementaires. <\/p>\n<p><strong>6. Sobel fournit-il une repr\u00e9sentation pour toutes les classes de risque des DIV ?<\/strong>  Oui. Sobel agit en tant que repr\u00e9sentant l\u00e9gal pour les dispositifs m\u00e9dicaux de diagnostic in vitro class\u00e9s de la classe I \u00e0 la classe IV selon la r\u00e9glementation br\u00e9silienne. Nous sommes \u00e9quip\u00e9s pour soutenir les enregistrements de produits complexes et \u00e0 haut risque avec toute la rigueur r\u00e9glementaire.  <\/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>Vous avez besoin d&rsquo;un repr\u00e9sentant local pour votre DIV au Br\u00e9sil ? Sobel est votre repr\u00e9sentant l\u00e9gal autoris\u00e9. Conformit\u00e9, vigilance et soutien.  <\/p>\n","protected":false},"author":15,"featured_media":13088,"parent":10198,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-11753","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 v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Repr\u00e9sentant l\u00e9gal pour l&#039;enregistrement des DIV au Br\u00e9sil | IVD Anvisa<\/title>\n<meta name=\"description\" content=\"Vous avez besoin d&#039;un repr\u00e9sentant local pour votre DIV au Br\u00e9sil ? Sobel est votre repr\u00e9sentant l\u00e9gal autoris\u00e9. 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