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small{color:#F2D27A!important}\n.ss-tb-p,.ss-tb-p.is-on{animation:none!important;background:#F7F5EF;border-radius:24px}\n.ss-tb-k{font-weight:600}\n\n\/* mobile refinements (07\/11\/2026) *\/\n.ss-cal time{background:#EEF1F8!important;color:#051B5A!important}.ss-cal .ss-pend time{background:#FFF3CC!important;color:#7A5A00!important}\n@media (max-width:767px){\n.ss-scard-n{grid-template-columns:1fr!important;gap:14px!important}.ss-scard{min-height:0!important}.ss-scard-in{padding-top:120px!important}\n.ss-tb{display:flex!important;overflow-x:auto;scroll-snap-type:x mandatory;gap:8px!important;padding-bottom:6px;margin-left:-20px;margin-right:-20px;padding-left:20px;padding-right:20px;scrollbar-width:none}\n.ss-tb::-webkit-scrollbar{display:none}\n.ss-tb{scroll-padding-left:20px;scroll-padding-right:20px}\n.ss button.ss-tb-t{flex:0 0 72%!important;scroll-snap-align:start;min-height:72px}\n}\n\n@media (min-width:768px) and (max-width:1024px){.ss-scards{grid-template-columns:1fr}.ss-scard{min-height:300px}}\n<\/style><div class=\"ss\" data-p=\"brh\"><section class=\"ss-sec ss-hero\"><div class=\"ss-in ss-hero-g\"><div class=\"ss-hero-t\"><p class=\"ss-crumb\"><a href=\"https:\/\/sobelconsult.com\/pt-br\/\">In\u00edcio<\/a> \u203a <a href=\"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/\">Solu\u00e7\u00f5es<\/a> \u203a <a href=\"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/dispositivos-medicos\/\">Dispositivos M\u00e9dicos<\/a> \u203a <a href=\"https:\/\/sobelconsult.com\/pt-br\/our-solutions-brazil\/\">Brasil<\/a> \u203a <span class=\"cur\">Detentor do Registro<\/span><\/p><p class=\"ss-eye\">Dispositivos m\u00e9dicos e IVD \u00b7 Brasil<\/p><h1 class=\"ss-h1\">Um detentor do registro independente dos seus <span>distribuidores<\/span><\/h1><p class=\"ss-lead\">Para vender um dispositivo m\u00e9dico ou IVD no Brasil, uma empresa brasileira com autoriza\u00e7\u00e3o da ANVISA \u00e9 a detentora da notifica\u00e7\u00e3o ou do registro. A Sobel oferece esse servi\u00e7o por meio de um parceiro homologado, para que seus produtos n\u00e3o fiquem presos a um distribuidor.<\/p><div class=\"ss-btns\"><a class=\"ss-btn\" href=\"#footer-cta\">Agende sua avalia\u00e7\u00e3o<\/a><a class=\"ss-more\" href=\"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/\">Encontre seu caminho regulat\u00f3rio \u2192<\/a><\/div><ul class=\"ss-seals\"><li><i>\ud83c\udfc6<\/i>Top Medical Device Regulatory Consultant \u00b7 LatAm 2025<\/li><li><i>\u2713<\/i>ISO 9001 certificada no Brasil<\/li><li><i>\ud83c\udf10<\/i>Atendimento em PT \u00b7 EN \u00b7 DE<\/li><\/ul><\/div><div class=\"ss-hero-p\"><img fetchpriority=\"high\" width=\"800\" height=\"605\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/c9b31ac3-9128-4677-9650-4db342706000-1024x775.png\" class=\"ss-photo\" alt=\"Profissional assinando uma declara\u00e7\u00e3o do fabricante legal ao lado da caixa de um dispositivo m\u00e9dico\" loading=\"eager\" fetchpriority=\"high\" decoding=\"async\" data-no-lazy=\"1\" sizes=\"(max-width: 1024px) 100vw, 600px\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/c9b31ac3-9128-4677-9650-4db342706000-1024x775.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/c9b31ac3-9128-4677-9650-4db342706000-300x227.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/c9b31ac3-9128-4677-9650-4db342706000-768x581.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/c9b31ac3-9128-4677-9650-4db342706000.png 1184w\" \/><\/div><\/div><\/section><section class=\"ss-sec ss-white\" id=\"ss-who\"><div class=\"ss-in\"><div class=\"ss-head ss-c\"><p class=\"ss-eye\">\u00c9 para voc\u00ea?<\/p><h2 class=\"ss-h2\">Para quem fazemos isso<\/h2><\/div><div class=\"ss-g4\"><div class=\"ss-card\"><b>Primeira vez no Brasil<\/b><span>Voc\u00ea n\u00e3o tem empresa no Brasil e precisa de um detentor para protocolar na ANVISA.<\/span><\/div><div class=\"ss-card\"><b>Registro com um distribuidor<\/b><span>Seu registro est\u00e1 com um distribuidor e voc\u00ea quer mais independ\u00eancia.<\/span><\/div><div class=\"ss-card\"><b>Mais de um distribuidor<\/b><span>Voc\u00ea quer trabalhar com v\u00e1rios importadores no Brasil.<\/span><\/div><div class=\"ss-card\"><b>Troca de detentor<\/b><span>Voc\u00ea quer mudar o detentor dos seus produtos e precisa saber o que \u00e9 poss\u00edvel no seu caso.<\/span><\/div><\/div><\/div><\/section><section class=\"ss-sec\" id=\"ss-get\"><div class=\"ss-in ss-split\"><div><p class=\"ss-eye\">O que voc\u00ea recebe<\/p><h2 class=\"ss-h2\">O que o servi\u00e7o de detentor inclui<\/h2><p class=\"ss-sub\">Uma equipe coordena o trabalho regulat\u00f3rio; nosso parceiro homologado atua como detentor dos seus produtos no Brasil.<\/p><ul class=\"ss-check\"><li>Detentor com Autoriza\u00e7\u00e3o de Funcionamento de Empresa (AFE) da ANVISA e respons\u00e1vel t\u00e9cnico, por meio do nosso parceiro homologado<\/li><li>Prepara\u00e7\u00e3o da notifica\u00e7\u00e3o ou do registro e acompanhamento junto \u00e0 ANVISA<\/li><li>Apoio em tecnovigil\u00e2ncia e a\u00e7\u00f5es de campo, a partir das informa\u00e7\u00f5es que voc\u00ea fornece<\/li><li>Altera\u00e7\u00f5es, dados de UDI e revalida\u00e7\u00f5es planejados em um calend\u00e1rio compartilhado<\/li><li>Documenta\u00e7\u00e3o t\u00e9cnica organizada para os pedidos da ANVISA<\/li><li>Apoio aos importadores com que voc\u00ea escolher trabalhar<\/li><\/ul><\/div><div class=\"ss-split-p\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"605\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-how-we-work-partners-1024x775.png\" class=\"ss-photo2\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-how-we-work-partners-1024x775.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-how-we-work-partners-300x227.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-how-we-work-partners-768x581.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-how-we-work-partners.png 1184w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/div><\/div><\/section><section class=\"ss-sec ss-white\" id=\"ss-own\"><div class=\"ss-in\"><div class=\"ss-head ss-c\"><h2 class=\"ss-h2\">Quem faz o qu\u00ea<\/h2><p class=\"ss-sub\">Pap\u00e9is claros desde o in\u00edcio. Os detalhes s\u00e3o definidos em contrato para cada caso.<\/p><\/div><div class=\"ss-tablewrap\"><table class=\"ss-table\"><thead><tr><th>Tema<\/th><th>Voc\u00ea, fabricante<\/th><th>O detentor (nosso parceiro)<\/th><th>Sobel<\/th><\/tr><\/thead><tbody><tr><th scope=\"row\">Produto e sistema da qualidade<\/th><td data-l=\"Voc\u00ea, fabricante\">\u00c9 dono do projeto, do dossi\u00ea t\u00e9cnico e do sistema da qualidade<\/td><td data-l=\"O detentor (nosso parceiro)\">Mant\u00e9m a documenta\u00e7\u00e3o que a ANVISA pode solicitar<\/td><td data-l=\"Sobel\">Adapta o dossi\u00ea ao formato da ANVISA<\/td><\/tr><tr><th scope=\"row\">Declara\u00e7\u00e3o do fabricante legal<\/th><td data-l=\"Voc\u00ea, fabricante\">Emite a declara\u00e7\u00e3o que nomeia o detentor<\/td><td data-l=\"O detentor (nosso parceiro)\">\u00c9 nomeado nela como detentor<\/td><td data-l=\"Sobel\">Prepara o texto com voc\u00ea<\/td><\/tr><tr><th scope=\"row\">Protocolo na ANVISA<\/th><td data-l=\"Voc\u00ea, fabricante\">Fornece documentos e respostas<\/td><td data-l=\"O detentor (nosso parceiro)\">Protocola como detentor<\/td><td data-l=\"Sobel\">Prepara a peti\u00e7\u00e3o e acompanha o processo<\/td><\/tr><tr><th scope=\"row\">Tecnovigil\u00e2ncia e a\u00e7\u00f5es de campo<\/th><td data-l=\"Voc\u00ea, fabricante\">Investiga e prop\u00f5e a\u00e7\u00f5es<\/td><td data-l=\"O detentor (nosso parceiro)\">Comunica-se com a ANVISA no Brasil<\/td><td data-l=\"Sobel\">Coordena os dois lados<\/td><\/tr><tr><th scope=\"row\">Importa\u00e7\u00e3o e venda<\/th><td data-l=\"Voc\u00ea, fabricante\">Escolhe os distribuidores<\/td><td data-l=\"O detentor (nosso parceiro)\">Apoia os importadores que voc\u00ea escolher<\/td><td data-l=\"Sobel\">Mant\u00e9m a documenta\u00e7\u00e3o em dia<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/section><section class=\"ss-sec\" id=\"ss-how\"><div class=\"ss-in\"><div class=\"ss-head ss-c\"><p class=\"ss-eye\">Como funciona<\/p><\/div><ol class=\"ss-steps\"><li><span class=\"ss-num\">1<\/span><b>An\u00e1lise<\/b><span>Avaliamos seus produtos, suas classes e a situa\u00e7\u00e3o atual no Brasil, inclusive registros que estejam com um distribuidor.<\/span><\/li><li><span class=\"ss-num\">2<\/span><b>Declara\u00e7\u00e3o<\/b><span>Voc\u00ea assina a declara\u00e7\u00e3o do fabricante legal que nomeia o detentor. Informamos o formato e a legaliza\u00e7\u00e3o necess\u00e1rios.<\/span><\/li><li><span class=\"ss-num\">3<\/span><b>Protocolo<\/b><span>O detentor protocola a notifica\u00e7\u00e3o ou o registro. Se voc\u00ea est\u00e1 trocando de detentor, primeiro verificamos qual caminho se aplica ao seu caso.<\/span><\/li><li><span class=\"ss-num\">4<\/span><b>Depois da aprova\u00e7\u00e3o<\/b><span>Tecnovigil\u00e2ncia, altera\u00e7\u00f5es, dados de UDI e revalida\u00e7\u00f5es, planejados em um calend\u00e1rio compartilhado.<\/span><\/li><\/ol><p class=\"ss-c ss-after\"><a class=\"ss-btn\" href=\"#footer-cta\">Fale com um especialista<\/a><\/p><\/div><\/section><section class=\"ss-sec ss-white\" id=\"ss-rel\"><div class=\"ss-in\"><div class=\"ss-head ss-c\"><p class=\"ss-eye\">Relacionados<\/p><h2 class=\"ss-h2\">Continue explorando<\/h2><\/div><div class=\"ss-g3\"><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/pt-br\/our-solutions-brazil\/\"><b>Dispositivos M\u00e9dicos \u00b7 Brasil<\/b><span>Classes, vias e o caminho completo na ANVISA.<\/span><em>\u2192<\/em><\/a><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/pt-br\/registro-ivd-anvisa\/\"><b>IVD \u00b7 Brasil<\/b><span>Como a ANVISA classifica e regula os IVDs.<\/span><em>\u2192<\/em><\/a><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/produto-travado-na-anvisa\/\"><b>Produto travado na ANVISA?<\/b><span>Indeferimentos e processos parados, analisados e respondidos.<\/span><em>\u2192<\/em><\/a><\/div><\/div><\/section><div class=\"ss-why\">\t\t<div data-elementor-type=\"container\" data-elementor-id=\"46192\" class=\"elementor elementor-46192 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\">Regulat\u00f3rio como <span class=\"sbw-gold\">decis\u00e3o de neg\u00f3cio<\/span>, n\u00e3o como checklist.<\/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 atuam em cada projeto, na mesma equipe, da primeira decis\u00e3o ao p\u00f3s-mercado.<\/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>Classifica\u00e7\u00e3o e sequ\u00eancia de mercados definidas primeiro. A classe certa desde o in\u00edcio evita retrabalho.<\/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 pr\u00f3pria<\/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 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 juntos.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-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 pr\u00f3pria de tecnologia cria os fluxos que mant\u00eam cada projeto rastre\u00e1vel e no 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 auditores.\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 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=\"Maik Endler, co-founder of Sobel\" 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 class=\"elementor-widget-container\">\n\t\t\t\t\t<style>.sbw-gold{color:#F2B705}.sbw-eye .elementor-heading-title{display:flex;align-items:center;gap:10px}.sbw-eye .elementor-heading-title:before{content:\"\";width:9px;height:9px;border-radius:50%;background:#F2B705;flex:none}.sbw-list ul{margin:0;padding-left:18px}.sbw-list li{margin:4px 0}.sbw-list li::marker{color:#F2B705}@media(max-width:1024px){.sbw-native > .sbw-l, .sbw-native > .sbw-card{width:100%!important}}<\/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\t\t<\/div>\n\t\t<\/div><section class=\"ss-sec\" id=\"ss-faq\"><div class=\"ss-in ss-faqg\"><div><p class=\"ss-eye\">Perguntas e respostas<\/p><h2 class=\"ss-h2\">Perguntas frequentes<\/h2><p class=\"ss-rules\"><b>Normas citadas nesta p\u00e1gina:<\/b> RDC 751\/2022 \u00b7 RDC 830\/2023 \u00b7 RDC 16\/2014 \u00b7 RDC 67\/2009 \u00b7 RDC 551\/2021 \u00b7 RDC 903\/2024 \u00b7 RDC 591\/2021 \u00b7 RDC 81\/2008<\/p><\/div><div class=\"ss-faq\"><details open><summary>Por que um fabricante estrangeiro precisa de um detentor no Brasil?<\/summary><p>A ANVISA concede notifica\u00e7\u00f5es e registros a uma empresa brasileira respons\u00e1vel pelo produto no Brasil. Essa empresa precisa de Autoriza\u00e7\u00e3o de Funcionamento de Empresa (AFE) da ANVISA, licen\u00e7a sanit\u00e1ria local e respons\u00e1vel t\u00e9cnico. Um fabricante estrangeiro sem subsidi\u00e1ria no Brasil normalmente trabalha com um detentor.<\/p><\/details><details><summary>A Sobel \u00e9 a detentora?<\/summary><p>N\u00e3o. A Sobel oferece o servi\u00e7o de detentor por meio de um parceiro homologado. A Sobel coordena o trabalho regulat\u00f3rio, e o parceiro \u00e9 o detentor da notifica\u00e7\u00e3o ou do registro para voc\u00ea.<\/p><\/details><details><summary>Meu registro pode sair do distribuidor?<\/summary><p>\u00c0s vezes. As op\u00e7\u00f5es dependem do tipo de produto, de ele ser notificado ou registrado e da colabora\u00e7\u00e3o do detentor atual. Em alguns casos \u00e9 poss\u00edvel uma transfer\u00eancia; em outros, o novo detentor protocola novamente. Analisamos o seu caso e explicamos as op\u00e7\u00f5es antes de qualquer passo.<\/p><\/details><details><summary>Posso vender por mais de um distribuidor?<\/summary><p>Em muitos casos, sim. Importadores com autoriza\u00e7\u00e3o da ANVISA pr\u00f3pria podem trabalhar com produtos de outro detentor, seguindo as regras de importa\u00e7\u00e3o da ANVISA. Verificamos como isso se aplica aos seus produtos.<\/p><\/details><details><summary>O que o detentor faz depois da aprova\u00e7\u00e3o?<\/summary><p>O detentor mant\u00e9m o produto em conformidade no Brasil: comunica-se com a ANVISA sobre tecnovigil\u00e2ncia e a\u00e7\u00f5es de campo, protocola altera\u00e7\u00f5es, mant\u00e9m a documenta\u00e7\u00e3o dispon\u00edvel e cuida das revalida\u00e7\u00f5es quando se aplicam. Planejamos essas etapas com voc\u00ea.<\/p><\/details><details><summary>O que voc\u00eas precisam de n\u00f3s?<\/summary><p>Uma declara\u00e7\u00e3o do fabricante legal que nomeie o detentor, sua documenta\u00e7\u00e3o t\u00e9cnica e, dependendo da classe, evid\u00eancias sobre o sistema da qualidade da sua fabrica\u00e7\u00e3o. Depois da primeira an\u00e1lise, enviamos um checklist para os seus produtos.<\/p><\/details><\/div><\/div><\/section><\/div><script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Por que um fabricante estrangeiro precisa de um detentor no Brasil?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"A ANVISA concede notifica\\u00e7\\u00f5es e registros a uma empresa brasileira respons\\u00e1vel pelo produto no Brasil. 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