{"id":7941,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/elaboracao-de-arquivo-de-envio-brasil\/"},"modified":"2025-09-17T16:16:00","modified_gmt":"2025-09-17T19:16:00","slug":"submission-file-elaboration-brazil","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/pt-br\/submission-file-elaboration-brazil\/","title":{"rendered":"Elabora\u00e7\u00e3o de arquivo de envio - Brasil"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7941\" class=\"elementor elementor-7941\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ca9e44b e-flex e-con-boxed e-con e-parent\" data-id=\"ca9e44b\" 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-c3b5f9c elementor-widget elementor-widget-heading\" data-id=\"c3b5f9c\" 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<h1 class=\"elementor-heading-title elementor-size-default\">Elabora\u00e7\u00e3o de dossi\u00ea t\u00e9cnico Anvisa<\/h1>\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-47228d3 e-flex e-con-boxed e-con e-parent\" data-id=\"47228d3\" 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-5a8230c elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"5a8230c\" 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>Para entrar no mercado brasileiro, seu dispositivo m\u00e9dico deve estar em conformidade com os requisitos do \u00f3rg\u00e3o regulagor. Ter toda a documenta\u00e7\u00e3o para registro de dispositivos m\u00e9dicos na Anvisa devidamente organizada, antes de protocolar o pedido no Solicita, \u00e9 o primeiro passo para uma jornada regulat\u00f3ria bem-sucedida. <\/p><p>Nossa equipe auxilia <strong>organiza\u00e7\u00f5es na estrutura\u00e7\u00e3o e coleta de todas as informa\u00e7\u00f5es t\u00e9cnicas necess\u00e1rias para registrar seu dispositivo m\u00e9dico no Solicita da Anvisa<\/strong><strong>,<\/strong> em conformidade com a legisla\u00e7\u00e3o nacional e normas regulat\u00f3rias.<\/p><p>Se voc\u00ea est\u00e1 lan\u00e7ando um novo produto ou expandindo sua presen\u00e7a internacional, n\u00f3s simplificamos o processo de submiss\u00e3o no Solicita e as complexidades associadas ao registro de dispositivo m\u00e9dico no Brasil.<\/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-6603680 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-widget elementor-widget-image\" data-id=\"6603680\" 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=\"1000\" height=\"667\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/03\/technical-file-elaboration.webp\" class=\"attachment-full size-full wp-image-6783\" alt=\"Person checking a\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/03\/technical-file-elaboration.webp 1000w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/03\/technical-file-elaboration-300x200.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/03\/technical-file-elaboration-768x512.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/>\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-25da29d elementor-widget elementor-widget-heading\" data-id=\"25da29d\" 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\">Como damos suporte \u00e0 jornada regulat\u00f3ria do seu dispositivo m\u00e9dico<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fc3ae87 elementor-widget elementor-widget-text-editor\" data-id=\"fc3ae87\" 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>Registrar um dispositivo m\u00e9dico no Brasil pode parecer complexo \u00e0 primeira vista, mas com a orienta\u00e7\u00e3o adequada, o processo se torna muito mais tranquilo. \u00c9 a\u00ed que nossa equipe entra: oferecemos um servi\u00e7o abrangente de suporte regulat\u00f3rio, gerenciando cada etapa da submiss\u00e3o \u2014 <strong>desde a classifica\u00e7\u00e3o do produto at\u00e9 o desenvolvimento do dossi\u00ea t\u00e9cnico Anvisa.<\/strong> <\/p><p>\u00c9 importante entender que a <strong>Anvisa classifica os dispositivos m\u00e9dicos em quatro classes de risco: I, II, III e IV. <\/strong>Esta classifica\u00e7\u00e3o determina o caminho regulat\u00f3rio a ser seguido. <strong>Nosso papel \u00e9 identificar exatamente onde seu dispositivo se encaixa para preparar um dossi\u00ea t\u00e9cnico Anvisa <\/strong>que leve a uma aprova\u00e7\u00e3o r\u00e1pida e sem surpresas. <\/p><p><strong>Somos seus parceiros estrat\u00e9gicos.  <\/strong>Por isso, nosso suporte \u00e9 adaptado \u00e0s necessidades espec\u00edficas do seu dispositivo, seja ele de Classe I ou Classe IV. Ajudamos seu neg\u00f3cio: <\/p><ul class=\"data-monday-blocks-wrapper\"><li class=\"monday-block-5\" contenteditable=\"true\" data-monday-block-type=\"5\" data-monday-block-content=\"{\"alignment\":\"left\",\"direction\":\"ltr\",\"deltaFormat\":[{\"insert\":\"Reviewing product classification to define the correct regulatory pathway;\"}],\"base64Encoded\":\"AQGkiufeAwAEAQl0ZXh0QmxvY2tKUmV2aWV3aW5nIHByb2R1Y3QgY2xhc3NpZmljYXRpb24gdG8gZGVmaW5lIHRoZSBjb3JyZWN0IHJlZ3VsYXRvcnkgcGF0aHdheTsA\"}\" data-monday-block-id=\"e068bb49-851d-4ac8-9566-b83297049a41\" data-monday-block-collapsed=\"undefined\" data-monday-block-is-collapsed-header=\"undefined\"><p>Revisando a classifica\u00e7\u00e3o do produto para definir o caminho regulat\u00f3rio correto;<\/p><\/li><li class=\"monday-block-5\" contenteditable=\"true\" data-monday-block-type=\"5\" data-monday-block-content=\"{\"alignment\":\"left\",\"direction\":\"ltr\",\"deltaFormat\":[{\"insert\":\"Compiling and organizing all technical documentation required by Anvisa;\"}],\"base64Encoded\":\"AQG9mqGzCQAEAQl0ZXh0QmxvY2tIQ29tcGlsaW5nIGFuZCBvcmdhbml6aW5nIGFsbCB0ZWNobmljYWwgZG9jdW1lbnRhdGlvbiByZXF1aXJlZCBieSBBbnZpc2E7AA==\"}\" data-monday-block-id=\"0b504cf1-d696-4e2d-9493-0f17f5294a3c\" data-monday-block-collapsed=\"undefined\" data-monday-block-is-collapsed-header=\"undefined\"><p>Compilando e organizando toda a documenta\u00e7\u00e3o para registro de dispositivos m\u00e9dicos Anvisa;<\/p><\/li><li class=\"monday-block-5\" contenteditable=\"true\" data-monday-block-type=\"5\" data-monday-block-content=\"{\"alignment\":\"left\",\"direction\":\"ltr\",\"deltaFormat\":[{\"insert\":\"Developing the technical dossier in accordance with RDC 751\/2022, which also defines the accepted languages;\"}],\"base64Encoded\":\"AQHPgKTsDgAEAQl0ZXh0QmxvY2tsRGV2ZWxvcGluZyB0aGUgdGVjaG5pY2FsIGRvc3NpZXIgaW4gYWNjb3JkYW5jZSB3aXRoIFJEQyA3NTEvMjAyMiwgd2hpY2ggYWxzbyBkZWZpbmVzIHRoZSBhY2NlcHRlZCBsYW5ndWFnZXM7AA==\"}\" data-monday-block-id=\"88d6a3d5-397f-4d64-a5e9-f8872062cdbb\" data-monday-block-collapsed=\"undefined\" data-monday-block-is-collapsed-header=\"undefined\"><p>Desenvolvendo o dossi\u00ea t\u00e9cnico Anvisa de acordo com a RDC 751\/2022, que tamb\u00e9m define os idiomas aceitos;<\/p><\/li><li class=\"monday-block-5\" contenteditable=\"true\" data-monday-block-type=\"5\" data-monday-block-content=\"{\"alignment\":\"left\",\"direction\":\"ltr\",\"deltaFormat\":[{\"insert\":\"Providing guidance on the format, language, and translation requirements for documents;\"}],\"base64Encoded\":\"AQH+p\/zVDAAEAQl0ZXh0QmxvY2tXUHJvdmlkaW5nIGd1aWRhbmNlIG9uIHRoZSBmb3JtYXQsIGxhbmd1YWdlLCBhbmQgdHJhbnNsYXRpb24gcmVxdWlyZW1lbnRzIGZvciBkb2N1bWVudHM7AA==\"}\" data-monday-block-id=\"c3513931-4d08-4ab6-8c7d-bd2662d44a67\" data-monday-block-collapsed=\"undefined\" data-monday-block-is-collapsed-header=\"undefined\"><p>Fornecendo orienta\u00e7\u00e3o sobre formato, idioma e requisitos de tradu\u00e7\u00e3o para documentos;<\/p><\/li><li class=\"monday-block-5\" contenteditable=\"true\" data-monday-block-type=\"5\" data-monday-block-content=\"{\"alignment\":\"left\",\"direction\":\"ltr\",\"deltaFormat\":[{\"insert\":\"Cross-referencing existing certifications and post-market data to strengthen your submission;\"}],\"base64Encoded\":\"AQHW1PLeDAAEAQl0ZXh0QmxvY2tdQ3Jvc3MtcmVmZXJlbmNpbmcgZXhpc3RpbmcgY2VydGlmaWNhdGlvbnMgYW5kIHBvc3QtbWFya2V0IGRhdGEgdG8gc3RyZW5ndGhlbiB5b3VyIHN1Ym1pc3Npb247AA==\"}\" data-monday-block-id=\"38e46d46-2559-4afe-8397-9dd4657fb804\" data-monday-block-collapsed=\"undefined\" data-monday-block-is-collapsed-header=\"undefined\"><p>Fazendo refer\u00eancia cruzada de certifica\u00e7\u00f5es existentes e dados de p\u00f3s-comercializa\u00e7\u00e3o para fortalecer sua submiss\u00e3o;<\/p><\/li><li class=\"monday-block-5\" contenteditable=\"true\" data-monday-block-type=\"5\" data-monday-block-content=\"{\"alignment\":\"left\",\"direction\":\"ltr\",\"deltaFormat\":[{\"insert\":\"Assist with questions related to additional certifications, such as BGMP (mandatory for Classes III and IV), INMETRO (for electrical equipment), and ANATEL (for wireless communication devices).\"}],\"base64Encoded\":\"AgGpuNmLDwDExo3EwAEIxo3EwAEJAUECxo3EwAEAAQEJdGV4dEJsb2NrCYTGjcTAAQjAAXNzaXN0IHdpdGggcXVlc3Rpb25zIHJlbGF0ZWQgdG8gYWRkaXRpb25hbCBjZXJ0aWZpY2F0aW9ucywgc3VjaCBhcyBCR01QIChtYW5kYXRvcnkgZm9yIENsYXNzZXMgSUlJIGFuZCBJViksIElOTUVUUk8gKGZvciBlbGVjdHJpY2FsIGVxdWlwbWVudCksIGFuZCBBTkFURUwgKGZvciB3aXJlbGVzcyBjb21tdW5pY2F0aW9uIGRldmljZXMpLgHGjcTAAQEACQ==\"}\" data-monday-block-id=\"c713e34a-a068-474a-9949-9d4f19691f88\" data-monday-block-collapsed=\"undefined\" data-monday-block-is-collapsed-header=\"undefined\"><p>Auxiliando com quest\u00f5es relacionadas a certifica\u00e7\u00f5es adicionais, como BGMP (obrigat\u00f3rio para Classes III e IV), INMETRO (para equipamentos el\u00e9tricos) e ANATEL (para dispositivos de comunica\u00e7\u00e3o sem fio).<\/p><\/li><\/ul>\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-5c01f58 e-flex e-con-boxed e-con e-parent\" data-id=\"5c01f58\" 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-ee215fc elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"ee215fc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1259\" height=\"275\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/02\/Rectangle-BlueSea.svg\" class=\"attachment-full size-full wp-image-4696\" alt=\"Shape blue sea\" \/>\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-486b1c1 elementor-widget elementor-widget-heading\" data-id=\"486b1c1\" 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\">Por que voc\u00ea precisa desse servi\u00e7o?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4bf23e3 e-flex e-con-boxed e-con e-child\" data-id=\"4bf23e3\" 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-e0b599c e-con-full e-flex e-con e-child\" data-id=\"e0b599c\" 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-52c94df elementor-widget elementor-widget-text-editor\" data-id=\"52c94df\" 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><strong>Estrat\u00e9gia eficiente de documenta\u00e7\u00e3o: <\/strong>Um plano claro e um arquivo de submiss\u00e3o no Solicita bem preparado ajudam a prevenir corre\u00e7\u00f5es desnecess\u00e1rias e reenvios.<\/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-60062f6 e-con-full e-flex e-con e-child\" data-id=\"60062f6\" 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-01b66a1 elementor-widget elementor-widget-text-editor\" data-id=\"01b66a1\" 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><strong>Arquivo t\u00e9cnico preciso e completo: <\/strong>Um dossi\u00ea t\u00e9cnico Anvisa adequadamente estruturado aumenta as chances de aceita\u00e7\u00e3o regulat\u00f3ria.<\/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-640b304 e-con-full e-flex e-con e-child\" data-id=\"640b304\" 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-21e66a0 elementor-widget elementor-widget-text-editor\" data-id=\"21e66a0\" 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><strong>Possibilidade de um processo de registro mais r\u00e1pido:<\/strong> Com suporte especializado e valida\u00e7\u00e3o de documentos, sua submiss\u00e3o flui pelo sistema com mais facilidade.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f8ca6bc elementor-widget elementor-widget-text-editor\" data-id=\"f8ca6bc\" 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>Ajudamos a preencher a lacuna entre os formatos de documenta\u00e7\u00e3o global e os requisitos regulat\u00f3rios brasileiros, simplificando o processo para que sua equipe possa se manter focada nas prioridades do neg\u00f3cio.<\/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-e7f2524 e-flex e-con-boxed e-con e-parent\" data-id=\"e7f2524\" 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-147b12f e-con-full e-flex e-con e-child\" data-id=\"147b12f\" 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-ad64db1 e-con-full e-flex e-con e-child\" data-id=\"ad64db1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ce9d794 elementor-widget elementor-widget-heading\" data-id=\"ce9d794\" 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\">Precisa de assist\u00eancia com a prepara\u00e7\u00e3o de documenta\u00e7\u00e3o regulat\u00f3ria Anvisa?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4bda438 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"4bda438\" 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>Se voc\u00ea estiver compilando um dossi\u00ea t\u00e9cnico da Anvisa para um novo produto ou atualizando documentos para um dispositivo m\u00e9dico existente, nossa equipe est\u00e1 pronta para ajudar.<\/p><p>Nossa experi\u00eancia com regulamenta\u00e7\u00e3o de dispositivos m\u00e9dicos no Brasil nos permite <strong>auxiliar fabricantes internacionais em todas as etapas do processo.<\/strong><\/p><p>Do planejamento inicial \u00e0 submiss\u00e3o no Solicita, atuamos como um parceiro estrat\u00e9gico focado na precis\u00e3o regulat\u00f3ria e efici\u00eancia operacional.<\/p><p>D\u00ea o pr\u00f3ximo passo para entrar no mercado brasileiro sem complica\u00e7\u00f5es!<\/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-b84236d elementor-widget elementor-widget-button\" data-id=\"b84236d\" 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%3DeyJpZCI6NzM0NSwidG9nZ2xlIjpmYWxzZX0%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\">Entre em contato conosco!<\/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>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Elabora\u00e7\u00e3o de 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