{"id":1831,"date":"2019-02-27T10:43:32","date_gmt":"2019-02-27T13:43:32","guid":{"rendered":"https:\/\/blog.arkmeds.com\/?p=1831"},"modified":"2026-10-08T13:45:07","modified_gmt":"2026-10-08T16:45:07","slug":"venda-de-equipamentos-medicos","status":"publish","type":"post","link":"https:\/\/arkmeds.com\/pt-br\/blog\/venda-de-equipamentos-medicos\/","title":{"rendered":"Quais requisitos da Anvisa se aplicam \u00e0 venda de dispositivos m\u00e9dicos?"},"content":{"rendered":"\n<article class=\"ark-research\" lang=\"pt-BR\">\n<style>.ark-research{color:#244C5A;line-height:1.75;font-family:Montserrat,sans-serif}.ark-research p{margin:0 0 1.2em}.ark-research h2{margin:1.8em 0 .7em;line-height:1.3}.ark-research table{width:100%;border-collapse:collapse;margin:1.4em 0;display:block;overflow-x:auto}.ark-research th,.ark-research td{padding:12px;border:1px solid #ccd9dd;text-align:left;vertical-align:top}.ark-research th{background:#244C5A;color:#fff}.ark-research a{color:#007f90;text-decoration:underline}.ark-research small{font-size:.85em}<\/style>\n<p><small>Revis\u00e3o editorial: Thiago Bajur \u00b7 Arkmeds \u00b7 8 de outubro de 2026<\/small><\/p>\n\n<p><strong>Autoriza\u00e7\u00e3o da empresa, regulariza\u00e7\u00e3o do produto e boas pr\u00e1ticas s\u00e3o verifica\u00e7\u00f5es diferentes.<\/strong> Para definir o que se aplica, \u00e9 necess\u00e1rio identificar o dispositivo e as atividades reais da empresa: fabricar, importar, distribuir, armazenar, transportar ou atuar no varejo n\u00e3o s\u00e3o enquadramentos intercambi\u00e1veis.<\/p>\n<h2>Por onde come\u00e7ar?<\/h2>\n<p>Descreva produto, finalidade, classe de risco, fabricante e cadeia comercial. Em seguida, identifique quem ser\u00e1 respons\u00e1vel pela regulariza\u00e7\u00e3o no Brasil e quais atividades cada estabelecimento executar\u00e1. S\u00f3 depois selecione o assunto e os documentos de peticionamento.<\/p>\n<table><thead><tr><th scope=\"col\">Verifica\u00e7\u00e3o<\/th><th scope=\"col\">O que esclarece<\/th><th scope=\"col\">Onde conferir<\/th><\/tr><\/thead><tbody><tr><td>Empresa e estabelecimento<\/td><td>Atividades autorizadas e requisitos locais<\/td><td>Servi\u00e7o oficial de AFE e vigil\u00e2ncia sanit\u00e1ria local.<\/td><\/tr><tr><td>Dispositivo<\/td><td>Enquadramento e situa\u00e7\u00e3o da regulariza\u00e7\u00e3o<\/td><td>RDC 751\/2022 e consulta oficial do produto.<\/td><\/tr><tr><td>Boas pr\u00e1ticas<\/td><td>Requisitos aplic\u00e1veis \u00e0 opera\u00e7\u00e3o<\/td><td>RDC 665\/2022 e orienta\u00e7\u00f5es da Anvisa.<\/td><\/tr><tr><td>Documenta\u00e7\u00e3o comercial<\/td><td>Correspond\u00eancia entre produto, rotulagem e finalidade<\/td><td>Documentos aprovados e instru\u00e7\u00f5es do detentor.<\/td><\/tr><\/tbody><\/table>\n<h2>Quando a AFE entra na an\u00e1lise?<\/h2>\n<p>O <a href=\"https:\/\/www.gov.br\/pt-br\/servicos\/solicitar-autorizacao-de-funcionamento-afe-dispositivos-medicos\">servi\u00e7o oficial de AFE para dispositivos m\u00e9dicos<\/a> lista as atividades sujeitas \u00e0 autoriza\u00e7\u00e3o e orienta o contato inicial com a vigil\u00e2ncia sanit\u00e1ria local. O peticionamento utiliza o sistema Solicita. N\u00e3o trate o certificado de boas pr\u00e1ticas como substituto autom\u00e1tico da AFE.<\/p>\n<h2>Todo dispositivo precisa de registro?<\/h2>\n<p>A <a href=\"https:\/\/anvisalegis.datalegis.net\/action\/ActionDatalegis.php?acao=abrirTextoAto&#038;cod_menu=9431&#038;cod_modulo=310&#038;link=S&#038;numeroAto=00000751&#038;orgao=RDC%2FDC%2FANVISA%2FMS&#038;seqAto=000&#038;tipo=RDC&#038;valorAno=2022\">RDC 751\/2022<\/a> distingue regulariza\u00e7\u00e3o por notifica\u00e7\u00e3o ou registro. A p\u00e1gina da Anvisa sobre <a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/setorregulado\/regularizacao\/produtos-para-saude\/notificacao\/notificacao-de-produtos-para-saude\">notifica\u00e7\u00e3o de dispositivos<\/a> descreve essa via para classes I e II dentro de seu enquadramento. A classifica\u00e7\u00e3o depende da finalidade e das regras aplic\u00e1veis; n\u00e3o basta o nome comercial.<\/p>\n<h2>Qual refer\u00eancia usar para boas pr\u00e1ticas?<\/h2>\n<p>A Anvisa explica que a <a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2022\/rdc-665-de-2022\">RDC 665\/2022 consolidou os requisitos de boas pr\u00e1ticas<\/a> antes presentes na RDC 16\/2013 e na IN 8\/2013. \u201cCumprir boas pr\u00e1ticas\u201d e \u201cobter determinado certificado\u201d devem ser analisados conforme a atividade e o processo, em vez de formar uma sequ\u00eancia universal de oito passos.<\/p>\n<h2>O que conferir antes de enviar uma peti\u00e7\u00e3o?<\/h2>\n<p>Use o assunto correto, a lista oficial de documentos e as instru\u00e7\u00f5es atuais do sistema. Confira dados de estabelecimento, respons\u00e1veis, produto e anexos. Valores de taxa, c\u00f3digos e formas de protocolo podem mudar; uma lista copiada de 2019 n\u00e3o deve orientar um pedido atual sem essa verifica\u00e7\u00e3o.<\/p>\n<p>Exemplo ilustrativo: uma empresa que passa de revenda a importa\u00e7\u00e3o precisa revisar seu enquadramento e suas responsabilidades. N\u00e3o se deve assumir que a documenta\u00e7\u00e3o existente cobre a nova atividade.<\/p>\n<p><small>Refer\u00eancias oficiais verificadas em 8\/10\/2026. O artigo apresenta um mapa de verifica\u00e7\u00f5es, n\u00e3o uma conclus\u00e3o regulat\u00f3ria sobre uma empresa ou produto espec\u00edfico.<\/small><\/p>\n<\/article>\n\n","protected":false},"excerpt":{"rendered":"<p>Diferencie autoriza\u00e7\u00e3o da empresa, regulariza\u00e7\u00e3o do dispositivo e boas pr\u00e1ticas antes de comercializar produtos para sa\u00fade no Brasil.<\/p>\n","protected":false},"author":29,"featured_media":18477,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[1],"tags":[],"class_list":["post-1831","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-geral"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Quais requisitos da Anvisa se aplicam \u00e0 venda de dispositivos m\u00e9dicos? 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