{"id":47371,"date":"2026-11-01T19:51:18","date_gmt":"2026-11-01T22:51:18","guid":{"rendered":"https:\/\/sobelconsult.com\/home\/nossas-solucoes-2\/estados-unidos\/"},"modified":"2026-11-01T19:53:26","modified_gmt":"2026-11-01T22:53:26","slug":"estados-unidos","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/estados-unidos\/","title":{"rendered":"Estados Unidos"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"47371\" class=\"elementor elementor-47371 elementor-47212\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3973c3f e-flex e-con-boxed e-con e-child\" data-id=\"3973c3f\" 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-dcd2d90 elementor-widget elementor-widget-html\" data-id=\"dcd2d90\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"sbm\">\n<nav class=\"sbm-crumb sb-crumb\" aria-label=\"Breadcrumb\"><a href=\"\/\">P\u00e1gina inicial<\/a><span aria-hidden=\"true\">\u203a<\/span><a href=\"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/\">Solu\u00e7\u00f5es<\/a><span aria-hidden=\"true\">\u203a<\/span><span aria-current=\"page\">Estados Unidos<\/span><\/nav>\n<div class=\"sbm-grid\">\n<div class=\"sbm-txt\">\n<p class=\"sbm-eye\">Dispositivos m\u00e9dicos \u00b7 Cosm\u00e9ticos<\/p>\n<h1 class=\"sbm-h1\">Seu caminho regulat\u00f3rio para os <span class=\"sbm-gold\">Estados Unidos<\/span>.<\/h1>\n<p class=\"sbm-lead\">Dispositivos m\u00e9dicos e cosm\u00e9ticos s\u00e3o regulamentados pela FDA. A gente define o seu caminho, prepara seus documentos e atua como seu agente nos EUA.<\/p>\n<div class=\"sbm-ctas\"><a class=\"sbm-btn\" href=\"#footer-cta\">Agende minha avalia\u00e7\u00e3o<\/a><a class=\"sbm-link\" href=\"#us-products\">Escolha seu produto \u2192<\/a><\/div>\n<p class=\"sbm-trust\">Dispositivos m\u00e9dicos \u00b7 Cosm\u00e9ticos \u00b7 Certifica\u00e7\u00e3o ISO 9001 no Brasil \u00b7 Atendimento em PT \u00b7 EN \u00b7 DE<\/p>\n<\/div>\n<div class=\"sbm-photo\"><img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-market-usa-capitol.png\" alt=\"O Capit\u00f3lio dos Estados Unidos em Washington, DC, com a bandeira americana na hora dourada\" width=\"1184\" height=\"896\" fetchpriority=\"high\"><\/div>\n<\/div>\n<\/div>\n<style>\n.sbm{font-family:'Host Grotesk',system-ui,sans-serif;color:#2B2E34;padding-top:17px}\n.sbm .sbm-crumb{display:flex;align-items:center;gap:8px;margin:0 0 32px;font-size:14px;line-height:20px;color:#4F535B;white-space:nowrap;min-width:0}\n.sbm .sbm-crumb a{color:#4F535B;text-decoration:none;font-weight:400;font-size:inherit;line-height:inherit;font-family:inherit}\n.sbm .sbm-crumb a:hover,.sbm .sbm-crumb a:focus{color:#051B5A;text-decoration:underline}\n.sbm .sbm-crumb [aria-current]{color:#051B5A;font-weight:600;overflow:hidden;text-overflow:ellipsis;min-width:0}\n.sbm-grid{display:flex;gap:48px;align-items:stretch}\n.sbm-txt{flex:1 1 55%;display:flex;flex-direction:column;min-width:0}\n.sbm .sbm-eye{display:flex;align-items:center;gap:10px;margin:0;font-size:13px;font-weight:600;letter-spacing:.16em;text-transform:uppercase;color:#051B5A;line-height:1.4}\n.sbm .sbm-eye:before{content:\"\";flex:0 0 9px;width:9px;height:9px;border-radius:50%;background:#F2B705}\n.sbm h1.sbm-h1{font-family:Lora,Georgia,serif;font-weight:700;font-size:50px;line-height:1.12;color:#051B5A;margin:22px 0 0;letter-spacing:0;text-transform:none}\n.sbm .sbm-gold{color:#F2B705}\n.sbm .sbm-lead{font-size:20px;line-height:1.55;color:#051B5A;margin:26px 0 0}\n.sbm-ctas{display:flex;flex-wrap:wrap;align-items:center;gap:24px;margin-top:32px}\n.sbm .sbm-btn{display:inline-flex;align-items:center;justify-content:center;min-height:52px;background:#F2B705;color:#3A2B00;font-weight:600;font-size:16px;line-height:1.3;padding:14px 28px;border-radius:999px;text-decoration:none;border:0;text-align:center}\n.sbm .sbm-btn:hover,.sbm .sbm-btn:focus{background:#E0A800;color:#3A2B00}\n.sbm .sbm-link{font-weight:600;font-size:18px;color:#051B5A;text-decoration:underline;text-decoration-color:#F2B705;text-underline-offset:4px}\n.sbm .sbm-link:hover,.sbm .sbm-link:focus{color:#051B5A;text-decoration-thickness:2px}\n.sbm .sbm-trust{font-size:14px;line-height:1.5;color:#4F535B;margin:36px 0 0}\n.sbm-photo{flex:0 1 45%;position:relative;min-height:320px;border-radius:22px;overflow:hidden;box-shadow:0 12px 32px rgba(7,31,99,.12)}\n.sbm-photo img{position:absolute;inset:0;width:100%!important;height:100%!important;max-width:none!important;object-fit:cover;object-position:50% 50%;border-radius:22px}\n@media (max-width:1024px){.sbm h1.sbm-h1{font-size:42px}.sbm-grid{gap:32px}}\n@media (min-width:1025px) and (max-height:840px){.sbm h1.sbm-h1{font-size:42px}.sbm .sbm-lead{margin-top:20px}.sbm-ctas{margin-top:28px}.sbm .sbm-trust{margin-top:28px}}\n@media (max-width:860px){.sbm-grid{flex-direction:column}.sbm-photo{flex-basis:auto;width:100%;min-height:0;height:300px}}\n@media (max-width:767px){.sbm{padding-top:0}.sbm .sbm-crumb{margin-bottom:20px;font-size:13px}.sbm-txt{text-align:center}.sbm-txt .sbm-eye{justify-content:center}.sbm h1.sbm-h1{font-size:32px;margin-top:16px}.sbm .sbm-lead{font-size:18px;margin-top:20px}.sbm-ctas{flex-direction:column;gap:12px;margin-top:24px}.sbm .sbm-btn{width:100%}.sbm .sbm-trust{margin-top:24px}.sbm-photo{height:240px}}\n<\/style>\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-43b7688 e-flex e-con-boxed e-con e-parent\" data-id=\"43b7688\" 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-f78be9d e-con-full e-flex e-con e-child\" data-id=\"f78be9d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7cdaacd elementor-widget elementor-widget-heading\" data-id=\"7cdaacd\" 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<p class=\"elementor-heading-title elementor-size-default\">DE ONDE VENS<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75e1abf elementor-widget elementor-widget-heading\" data-id=\"75e1abf\" 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\">Dois pontos de partida, um mercado<\/h2>\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-75ffb3a e-con-full e-flex e-con e-child\" data-id=\"75ffb3a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-bff56ef e-con-full e-flex e-con e-child\" data-id=\"bff56ef\" 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-0ba9d0f elementor-widget elementor-widget-heading\" data-id=\"0ba9d0f\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Primeira vez nos EUA<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-abb103b elementor-widget elementor-widget-text-editor\" data-id=\"abb103b\" 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>Voc\u00ea est\u00e1 fora dos Estados Unidos e quer alcan\u00e7ar clientes americanos com um plano bem definido.<\/p><ul class=\"sb-li\" style=\"margin:12px 0 0;padding-left:18px;color:#2B2E34;line-height:1.7\"><li>Seu caminho na FDA j\u00e1 est\u00e1 definido: 510(k), De Novo ou PMA<\/li><li>Registro da empresa, com a Sobel como seu agente nos EUA<\/li><li>Cosm\u00e9ticos: registro MoCRA, listagem e comprova\u00e7\u00e3o de seguran\u00e7a<\/li><\/ul>\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-678f419 e-con-full e-flex e-con e-child\" data-id=\"678f419\" 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-eed8928 elementor-widget elementor-widget-heading\" data-id=\"eed8928\" 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<h3 class=\"elementor-heading-title elementor-size-default\">J\u00e1 foi aprovado em outro mercado<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7319913 elementor-widget elementor-widget-text-editor\" data-id=\"7319913\" 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>Seu produto j\u00e1 est\u00e1 no mercado no Brasil ou na Europa, e os EUA s\u00e3o o seu pr\u00f3ximo passo.<\/p><ul class=\"sb-li\" style=\"margin:12px 0 0;padding-left:18px;color:#2B2E34;line-height:1.7\"><li>O que pode ser reutilizado do seu dossi\u00ea da ANVISA ou da certifica\u00e7\u00e3o CE<\/li><li>Discrep\u00e2ncias em rela\u00e7\u00e3o \u00e0s regras da FDA e ao QMSR, com base na ISO 13485<\/li><li>R\u00f3tulos e alega\u00e7\u00f5es adaptados aos requisitos dos EUA<\/li><\/ul>\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-2c6782d e-flex e-con-boxed e-con e-parent\" data-id=\"2c6782d\" data-element_type=\"container\" data-e-type=\"container\" id=\"us-products\" 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-a296a85 animated-slow elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"a296a85\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:200}\" 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\">O que voc\u00ea vai levar pros EUA?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-dc1e849 e-flex e-con-boxed e-con e-child\" data-id=\"dc1e849\" data-element_type=\"container\" data-e-type=\"container\" id=\"regulatory-path\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-56a071b animated-slow elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"56a071b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:400}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Cada produto segue suas pr\u00f3prias regras da FDA. Escolha o seu para ver todo o processo.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8c191d6 sobel-solutions-section e-con-full e-flex e-con e-child\" data-id=\"8c191d6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;none&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-8b9033b e-con-full e-flex e-con e-child\" data-id=\"8b9033b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-1d29157 e-con-full e-flex e-con e-child\" data-id=\"1d29157\" 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-4ace369 elementor-widget elementor-widget-image\" data-id=\"4ace369\" 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=\"800\" height=\"534\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-1024x683.webp\" class=\"attachment-large size-large wp-image-47091\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-1024x683.webp 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-300x200.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-768x512.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand.webp 1248w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<div class=\"elementor-element elementor-element-5ddef11 e-con-full icone-segmento e-flex e-con e-child\" data-id=\"5ddef11\" 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-718a074 elementor-widget elementor-widget-image\" data-id=\"718a074\" 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=\"500\" height=\"500\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4.png\" class=\"attachment-large size-large wp-image-47095\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4.png 500w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4-300x300.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4-150x150.png 150w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>\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<div class=\"elementor-element elementor-element-f6bb005 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"f6bb005\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Dispositivos m\u00e9dicos<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-223c9b7 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"223c9b7\" 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>Equipamentos, implantes e software, desde a escolha do caminho a seguir at\u00e9 a apresenta\u00e7\u00e3o do pedido \u00e0 FDA.<\/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-bca47e9 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"bca47e9\" 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 elementor-animation-grow\" href=\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/\">\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<i aria-hidden=\"true\" class=\" arrow_right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Dispositivos m\u00e9dicos nos EUA<\/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<div class=\"elementor-element elementor-element-d39bd55 e-con-full e-flex e-con e-child\" data-id=\"d39bd55\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-d41995f e-con-full e-flex e-con e-child\" data-id=\"d41995f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_scale_effect&quot;:&quot;yes&quot;,&quot;motion_fx_scale_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;motion_fx_scale_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_scale_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:80}},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-524afc4 elementor-widget elementor-widget-image\" data-id=\"524afc4\" 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=\"800\" height=\"534\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-1024x683.webp\" class=\"attachment-large size-large wp-image-47099\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-1024x683.webp 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-300x200.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-768x512.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand.webp 1248w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<div class=\"elementor-element elementor-element-caee5a2 e-con-full icone-segmento e-flex e-con e-child\" data-id=\"caee5a2\" 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-1471874 elementor-widget elementor-widget-image\" data-id=\"1471874\" 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 loading=\"lazy\" decoding=\"async\" width=\"500\" height=\"500\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4.png\" class=\"attachment-large size-large wp-image-47103\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4.png 500w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4-300x300.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4-150x150.png 150w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>\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<div class=\"elementor-element elementor-element-e067318 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"e067318\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Cosm\u00e9ticos<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-558b144 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"558b144\" 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>Cuidados com a pele, maquiagem e higiene pessoal, desde o registro no MoCRA at\u00e9 a rotulagem.<\/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-8a60370 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"8a60370\" 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 elementor-animation-grow\" href=\"https:\/\/sobelconsult.com\/pt-br\/registro-de-cosmeticos-estados-unidos\/\">\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<i aria-hidden=\"true\" class=\" arrow_right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Produtos de beleza nos EUA<\/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<\/div>\n\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-268b121 e-flex e-con-boxed e-con e-parent\" data-id=\"268b121\" data-element_type=\"container\" data-e-type=\"container\" id=\"local-presence\" 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-65d4d5f elementor-widget elementor-widget-html\" data-id=\"65d4d5f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"sbg\" id=\"us-services\">\n<p class=\"sbg-ey\" data-k=\"ey\">SERVI\u00c7OS NOS ESTADOS UNIDOS<\/p>\n<h2 class=\"sbg-h\" data-k=\"h\">Tudo o que fazemos para o mercado dos EUA<\/h2>\n<p class=\"sbg-sub\" data-k=\"sub\">Estrat\u00e9gia, documenta\u00e7\u00e3o e representa\u00e7\u00e3o perante a FDA, tudo com uma \u00fanica equipe.<\/p>\n<div class=\"sbg-f\" role=\"group\" aria-label=\"Filter by product\">\n<button type=\"button\" class=\"sbg-c on\" data-f=\"all\" data-k=\"all\">Todos<\/button>\n<button type=\"button\" class=\"sbg-c\" data-f=\"md\"><span class=\"sbg-d\" style=\"background:#2A72C8\"><\/span><span data-k=\"md\">Dispositivos m\u00e9dicos<\/span><\/button>\n<button type=\"button\" class=\"sbg-c\" data-f=\"co\"><span class=\"sbg-d\" style=\"background:#9471CF\"><\/span><span data-k=\"co\">Cosm\u00e9ticos<\/span><\/button>\n<\/div>\n<div class=\"sbg-g\">\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/pt-br\/regulatorio-qualidade\/#registration\"><h3 data-k=\"t1\">Estrat\u00e9gia regulat\u00f3ria e processo da FDA<\/h3><p data-k=\"d1\">Classifica\u00e7\u00e3o, c\u00f3digo do produto e o caminho certo: 510(k), De Novo ou PMA.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/consultoria-fda-dispositivos-medicos\/\"><h3 data-k=\"t2\">Pedidos 510(k), De Novo e PMA<\/h3><p data-k=\"d2\">Arquivo de submiss\u00e3o e respostas \u00e0s solicita\u00e7\u00f5es da FDA.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/pt-br\/regulatorio-qualidade\/#quality-systems\"><h3 data-k=\"t3\">Sistema de qualidade (QMSR)<\/h3><p data-k=\"d3\">21 CFR 820, agora em conformidade com a ISO 13485, al\u00e9m de auditorias.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/pt-br\/evidencia-clinica-seguranca-produto\/#biological-evaluation\"><h3 data-k=\"t4\">Avalia\u00e7\u00e3o biol\u00f3gica e cl\u00ednica<\/h3><p data-k=\"d4\">ISO 10993 e evid\u00eancias cl\u00ednicas para a FDA.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"co\" href=\"https:\/\/sobelconsult.com\/pt-br\/registro-de-cosmeticos-estados-unidos\/listagem-de-produtos-instalacoes-fda\/\"><h3 data-k=\"t5\">Registro e listagem na MoCRA<\/h3><p data-k=\"d5\">Registro de instala\u00e7\u00f5es e listagem de produtos junto \u00e0 FDA.<\/p><span class=\"sbg-tg\"><i class=\"co\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"co\" href=\"https:\/\/sobelconsult.com\/pt-br\/registro-de-cosmeticos-estados-unidos\/mocra-safety-substantiation\/\"><h3 data-k=\"t6\">Comprova\u00e7\u00e3o de seguran\u00e7a e rotulagem<\/h3><p data-k=\"d6\">Evid\u00eancias de seguran\u00e7a e r\u00f3tulos que seguem as regras da FDA.<\/p><span class=\"sbg-tg\"><i class=\"co\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md co\" href=\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/us-agent-fda\/\" data-hco=\"\/our-solutions-cosmetics-usa\/fda-agent-service-for-cosmetics\/\"><h3 data-k=\"t7\">Agente nos EUA<\/h3><p data-k=\"d7\">A Sobel atua como seu agente nos EUA junto \u00e0 FDA.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><i class=\"co\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md co\" href=\"https:\/\/sobelconsult.com\/pt-br\/como-trabalhamos\/#shw-models\"><h3 data-k=\"t8\">Suporte cont\u00ednuo<\/h3><p data-k=\"d8\">Suporte mensal para altera\u00e7\u00f5es, renova\u00e7\u00f5es e atualiza\u00e7\u00f5es da FDA.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><i class=\"co\"><\/i><\/span><\/a>\n<\/div>\n<\/div>\n<style>\n.sbg{max-width:1200px;margin:0 auto;font-family:'Host Grotesk',sans-serif;color:#2B2E34;text-align:center;scroll-margin-top:94px}\n.sbg-ey{display:inline-flex;align-items:center;gap:12px;margin:0;font-size:13px;font-weight:600;letter-spacing:.16em;color:#051B5A}\n.sbg-ey:before{content:\"\";width:9px;height:9px;border-radius:50%;background:#F2B705}\n.sbg-h{margin:20px 0 0;font-family:'Lora',Georgia,serif;font-weight:700;font-size:40px;line-height:1.15;color:#051B5A}\n.sbg-sub{margin:24px auto 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.sbg-t{padding:20px 22px}\n.sbg .sbg-t:hover,.sbg .sbg-t:focus{background:#FFFFFF!important;color:inherit!important}\n.sbg .sbg-t:hover h3{color:#051B5A!important}\n@media (min-width:768px) and (min-height:841px){\n.elementor .elementor-element-2c6782d .elementor-element.elementor-element-56a071b{margin:2px 0 24px!important}\n}\n@media (min-width:1025px) and (max-height:840px){\n.sbg .sbg-h{font-size:34px}\n.sbg .sbg-sub{display:none}\n.sbg .sbg-f{margin-top:20px}\n.sbg .sbg-g{gap:16px;margin-top:20px}\n.sbg .sbg-t{padding:16px 18px;gap:8px}\n.elementor .elementor-element-2c6782d .elementor-element.elementor-element-56a071b{margin:0 0 18px!important}\n}\n@media (max-width:1024px){\n.sbg .sbg-g{gap:16px}\n}\n@media (max-width:767px){\n.elementor .elementor-element-2c6782d .elementor-element.elementor-element-5ddef11,.elementor .elementor-element-2c6782d .elementor-element.elementor-element-caee5a2{width:76px!important;max-width:76px!important;--width:76px;align-self:center!important;margin:-38px auto 6px!important}\n.elementor .elementor-element-2c6782d .elementor-element-5ddef11 img,.elementor .elementor-element-2c6782d .elementor-element-caee5a2 img{width:76px!important;height:76px!important}\n.sbg .sbg-sub{margin-top:14px}\n.sbg .sbg-f{margin-top:20px}\n.sbg .sbg-g{grid-template-columns:repeat(2,minmax(0,1fr));gap:10px;margin-top:20px}\n.sbg .sbg-t{padding:14px 12px;gap:8px;border-radius:14px}\n.sbg .sbg-t h3{font-size:15px;line-height:1.3}\n.sbg .sbg-t p{display:none}\n.sbg .sbg-tg i{width:20px;height:5px}\n.sbg .sbg-c{padding:6px 12px;min-height:40px;font-size:14px}\n}\n<\/style>\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-2ed0715 e-flex e-con-boxed e-con e-parent\" data-id=\"2ed0715\" 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-e15dd9a elementor-widget elementor-widget-html\" data-id=\"e15dd9a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"sbs2\"><a href=\"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/#sr-guide\" class=\"sbs2-c\"><span class=\"sbs2-i\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"26\" height=\"26\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\"><circle cx=\"6\" cy=\"19\" r=\"3\"><\/circle><path d=\"M9 19h8.5a3.5 3.5 0 0 0 0-7h-11a3.5 3.5 0 0 1 0-7H15\"><\/path><circle cx=\"18\" cy=\"5\" r=\"3\"><\/circle><\/svg><\/span><span class=\"sbs2-e\">J\u00c1 FOI APROVADO EM OUTRO LUGAR?<\/span><span class=\"sbs2-t\">Comece pelo seu dossi\u00ea da ANVISA ou da CE<\/span><span class=\"sbs2-d\">Veja o que pode ser reutilizado nos EUA antes de se comprometer com um projeto.<\/span><span class=\"sbs2-l\">Trace seu caminho com a Sobel Route \u2192<\/span><\/a><a href=\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/us-agent-fda\/\" class=\"sbs2-c\"><span class=\"sbs2-i\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"26\" height=\"26\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\"><path d=\"M12 22s8-4 8-10V5l-8-3-8 3v7c0 6 8 10 8 10z\"><\/path><path d=\"m9 12 2 2 4-4\"><\/path><\/svg><\/span><span class=\"sbs2-e\">PRECISA DE UM AGENTE NOS EUA?<\/span><span class=\"sbs2-t\">Obrigat\u00f3rio para fabricantes de dispositivos m\u00e9dicos estrangeiros<\/span><span class=\"sbs2-d\">A Sobel atua como seu agente nos EUA perante a FDA, com um \u00fanico ponto de contato para todas as solicita\u00e7\u00f5es.<\/span><span class=\"sbs2-l\">Conhe\u00e7a o servi\u00e7o de agente nos EUA \u2192<\/span><\/a><\/div><style>.sbs2{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:24px;font-family:'Host Grotesk',sans-serif}.sbs2-c{display:flex;flex-direction:column;gap:10px;background:#051B5A;border-radius:18px;padding:30px;text-decoration:none;transition:transform .25s ease}.sbs2-c:hover{transform:translateY(-3px)}.sbs2-i{width:52px;height:52px;border-radius:50%;border:1.5px solid #F2B705;display:flex;align-items:center;justify-content:center}.sbs2-e{font-size:13px;font-weight:700;letter-spacing:.14em;color:#F2B705;margin-top:6px}.sbs2-t{font-family:Lora,Georgia,serif;font-weight:700;font-size:24px;line-height:1.25;color:#FFFFFF}.sbs2-d{font-size:16px;line-height:1.55;color:#D9DFEE}.sbs2-l{margin-top:auto;padding-top:8px;font-weight:600;color:#F2B705;font-size:15.5px}@media(max-width:767px){.sbs2{grid-template-columns:minmax(0,1fr)}.sbs2-t{font-size:21px}}<\/style>\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-a19c938 e-con-full e-flex e-con e-parent\" data-id=\"a19c938\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c25134c elementor-widget elementor-widget-template\" data-id=\"c25134c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"template.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-template\">\n\t\t\t\t\t<div data-elementor-type=\"container\" data-elementor-id=\"46192\" class=\"elementor elementor-46192 elementor-46189 elementor-46189\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5fc3d48 e-flex e-con-boxed e-con e-parent\" data-id=\"5fc3d48\" data-element_type=\"container\" data-e-type=\"container\" id=\"why-sobel\" 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-629f752 sbw-native e-flex e-con-boxed e-con e-child\" data-id=\"629f752\" 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-f0eb2c5 e-con-full sbw-l e-flex e-con e-child\" data-id=\"f0eb2c5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a36dc14 elementor-widget elementor-widget-heading\" data-id=\"a36dc14\" 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<p class=\"elementor-heading-title elementor-size-default\">Por que a Sobel<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c265d3 elementor-widget elementor-widget-heading\" data-id=\"3c265d3\" 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 regulamenta\u00e7\u00e3o como uma <span class=\"sbw-gold\">decis\u00e3o<\/span> de neg\u00f3cios <span class=\"sbw-gold\">,<\/span> n\u00e3o como uma lista de verifica\u00e7\u00e3o.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-85f7a25 elementor-widget elementor-widget-text-editor\" data-id=\"85f7a25\" 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>Quatro \u00e1reas trabalham juntas em cada projeto, na mesma equipe, desde a primeira decis\u00e3o at\u00e9 a fase p\u00f3s-lan\u00e7amento.<\/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-a67f4ac e-con-full e-grid e-con e-child\" data-id=\"a67f4ac\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-693f1b5 e-con-full e-flex e-con e-child\" data-id=\"693f1b5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-85f3478 elementor-widget elementor-widget-heading\" data-id=\"85f3478\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Estrat\u00e9gia<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-97525b9 elementor-widget elementor-widget-text-editor\" data-id=\"97525b9\" 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>Primeiro, decide-se a classifica\u00e7\u00e3o e a sequ\u00eancia de mercado. Escolher a classe certa desde o in\u00edcio evita ter que refazer o trabalho.<\/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-6495a0a e-con-full e-flex e-con e-child\" data-id=\"6495a0a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-836adaf elementor-widget elementor-widget-heading\" data-id=\"836adaf\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Ci\u00eancia em casa<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-67ceef1 elementor-widget elementor-widget-text-editor\" data-id=\"67ceef1\" 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>Avalia\u00e7\u00e3o biol\u00f3gica, cl\u00ednica e toxicol\u00f3gica feita pela nossa pr\u00f3pria equipe de Evid\u00eancia Cl\u00ednica e Seguran\u00e7a do Produto.<\/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-32f324f e-con-full e-flex e-con e-child\" data-id=\"32f324f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-42f4202 elementor-widget elementor-widget-heading\" data-id=\"42f4202\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Regulat\u00f3rio, cinco mercados<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af07af2 elementor-widget elementor-widget-text-editor\" data-id=\"af07af2\" 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>ANVISA, FDA, MDR da UE, MHRA e Health Canada, coordenados em conjunto.<\/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-509c85a e-con-full e-flex e-con e-child\" data-id=\"509c85a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e1ba45f elementor-widget elementor-widget-heading\" data-id=\"e1ba45f\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Tecnologia<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c8184f elementor-widget elementor-widget-text-editor\" data-id=\"2c8184f\" 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>Uma equipe de tecnologia especializada cria os fluxos de trabalho que garantem que cada projeto seja rastre\u00e1vel e seja conclu\u00eddo dentro do prazo.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4d1d951 e-con-full sbw-card e-flex e-con e-child\" data-id=\"4d1d951\" 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-afde0f5 elementor-widget elementor-widget-text-editor\" data-id=\"afde0f5\" 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>\u201cSabemos como os auditores pensam, porque j\u00e1 fomos um deles.\u201d<\/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-4b051b4 e-con-full e-flex e-con e-child\" data-id=\"4b051b4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ed4939a elementor-widget elementor-widget-image\" data-id=\"ed4939a\" 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 loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-300x300.webp\" class=\"attachment-medium size-medium wp-image-44766\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-300x300.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-150x150.webp 150w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-768x768.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait.webp 800w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/>\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<div class=\"elementor-element elementor-element-0a86da7 e-con-full e-flex e-con e-child\" data-id=\"0a86da7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ea43503 elementor-widget elementor-widget-heading\" data-id=\"ea43503\" 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<p class=\"elementor-heading-title elementor-size-default\">Maik Endler<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d696004 elementor-widget elementor-widget-heading\" data-id=\"d696004\" 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<p class=\"elementor-heading-title elementor-size-default\">Fundador e CEO<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7c430b7 elementor-widget elementor-widget-text-editor\" data-id=\"7c430b7\" 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<ul><li>Engenheiro mec\u00e2nico, formado na Alemanha<\/li><li>Ex-auditor da BSI (\u00d3rg\u00e3o Notificado)<\/li><li>Experi\u00eancia no setor na Sirona (agora Dentsply Sirona)<\/li><\/ul>\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-87729bb elementor-align-left elementor-widget elementor-widget-button\" data-id=\"87729bb\" 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\/pt-br\/home\/about-us\/\">\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\">Conhe\u00e7a a equipe \u2192<\/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\t\t<div class=\"elementor-element elementor-element-446ce21 elementor-widget elementor-widget-html\" data-id=\"446ce21\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div 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i:after{content:\"\";position:absolute;left:50%;top:50%;width:12px;height:1.6px;background:#051B5A;transform:translate(-50%,-50%)}\n.sbf-item summary i:after{transform:translate(-50%,-50%) rotate(90deg);transition:transform .2s}\n.sbf-item[open] summary i:after{transform:translate(-50%,-50%) rotate(0deg)}\n.sbf-a{padding:0 22px 20px}\n.sbf-a p{margin:0;font-size:16px;line-height:1.6;color:#2B2E34;max-width:720px}\n@media(max-width:767px){.sbf-intro h2{font-size:32px}.sbf{gap:32px}}\n<\/style>\n<div class=\"sbf\">\n<div class=\"sbf-intro\"><p class=\"sbf-eye\">Perguntas frequentes \u00b7 ESTADOS UNIDOS<\/p><h2>O que as empresas perguntam antes de entrar nos <em>EUA<\/em><\/h2><p class=\"sbf-lead\">Respostas curtas sobre dispositivos m\u00e9dicos e cosm\u00e9ticos. Cada p\u00e1gina de produto traz mais detalhes.<\/p><a class=\"sbf-btn\" href=\"#footer-cta\">Fa\u00e7a sua pergunta \u2192<\/a><\/div>\n<div class=\"sbf-list\"><details class=\"sbf-item\" open=\"\"><summary><span>Quem regula os dispositivos m\u00e9dicos e os cosm\u00e9ticos nos EUA?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Ambos s\u00e3o regulamentados pela <strong>FDA<\/strong> (Ag\u00eancia de Alimentos e Medicamentos dos EUA) de acordo com a Lei Federal de Alimentos, Medicamentos e Cosm\u00e9ticos. Para os cosm\u00e9ticos, a <strong>Lei de Moderniza\u00e7\u00e3o da Regulamenta\u00e7\u00e3o de Cosm\u00e9ticos de 2022 (MoCRA)<\/strong> introduziu o registro de instala\u00e7\u00f5es, a listagem de produtos e a comprova\u00e7\u00e3o de seguran\u00e7a.<\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>Preciso de um agente nos EUA?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Para dispositivos m\u00e9dicos, sim. Empresas estrangeiras precisam indicar um <strong>agente nos EUA<\/strong> ao se registrarem na FDA (21 CFR 807.40). A Sobel atua como seu agente nos EUA. Para cosm\u00e9ticos, a gente analisa qual tipo de representa\u00e7\u00e3o o seu caso precisa. <a href=\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/us-agent-fda\/\">Saiba mais sobre o servi\u00e7o de agente nos EUA.<\/a><\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>Qual \u00e9 o processo da FDA que meu dispositivo precisa seguir?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Isso depende da classifica\u00e7\u00e3o do dispositivo. A maioria dos dispositivos da Classe II precisa de um <strong>510(k)<\/strong>; novos dispositivos de baixo risco, sem um dispositivo de refer\u00eancia, podem seguir o processo <strong>De Novo<\/strong>; e a maioria dos dispositivos da Classe III precisa de um <strong>PMA<\/strong>. Alguns dispositivos est\u00e3o isentos da submiss\u00e3o pr\u00e9-comercializa\u00e7\u00e3o. Definir o caminho a seguir \u00e9 o primeiro passo.<\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>O que mudou com o QMSR da FDA?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Desde <strong>2 de fevereiro de 2026<\/strong>, o Regulamento do Sistema de Gest\u00e3o da Qualidade (21 CFR 820) incorpora <strong>a norma ISO 13485:2016<\/strong> por refer\u00eancia. 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A Sobel oferece suporte \u00e0 classifica\u00e7\u00e3o, ao registro e \u00e0 estrat\u00e9gia regulat\u00f3ria para a aprova\u00e7\u00e3o de comercializa\u00e7\u00e3o.<\/p>\n","protected":false},"author":18,"featured_media":25479,"parent":41037,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_angie_page":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-47371","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Entrada no mercado dos EUA para dispositivos m\u00e9dicos e cosm\u00e9ticos | Sobel<\/title>\n<meta name=\"description\" content=\"Entre no mercado dos EUA com um plano claro para a FDA: 510(k), De Novo ou PMA, registro e listagem no MoCRA, e a Sobel como seu agente nos EUA.\" \/>\n<meta name=\"robots\" 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