{"id":41362,"date":"2026-07-16T18:19:34","date_gmt":"2026-07-16T21:19:34","guid":{"rendered":"https:\/\/sobelconsult.com\/nossas-solucoes-2\/dispositivos-medicos\/"},"modified":"2026-10-31T20:19:09","modified_gmt":"2026-10-31T23:19:09","slug":"dispositivos-medicos","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/dispositivos-medicos\/","title":{"rendered":"Dispositivos m\u00e9dicos"},"content":{"rendered":"\n<style>\n.sbc{font-family:'Host Grotesk',system-ui,sans-serif;color:#2B2E34;background:#FAF7F2;width:100vw;margin-left:calc(50% - 50vw);overflow:hidden}\nhtml,body{overflow-x:clip}\n.sbc section{width:100%;box-sizing:border-box}\n.sbc h1,.sbc h2,.sbc h3{letter-spacing:normal;text-transform:none}\n.sbc p{margin-bottom:0}\n.sbc a{text-decoration:none}\n.sbc img{max-width:100%;border:0}\n.sbc section[id]{scroll-margin-top:94px}\n.sbc{margin:0}\n.sbc a{color:#051B5A}\n.sbc *{box-sizing:border-box}\n.sbc 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Grotesk',system-ui,sans-serif;color:#051B5A}.sbc .why .wl em{font-style:normal;font-size:11px;letter-spacing:.06em;text-transform:uppercase;background:#E3EEFB;color:#174A8C;border-radius:999px;padding:3px 9px}.sbc .why ul{margin:0;padding-left:18px;font-size:14px;line-height:1.5;color:#2B2E34}.sbc .chg{margin-top:20px;display:grid;grid-template-columns:auto minmax(0,1fr) auto;gap:16px 20px;align-items:center;background:#051B5A;color:#DCE4FF;border-radius:16px;padding:20px 24px}.sbc .chg b{color:#FFFFFF}.sbc .chg p{margin:0;font-size:16px;line-height:1.55}.sbc .chg a{color:#F2B705;font-weight:600;text-decoration:none;white-space:nowrap}@media(max-width:640px){.sbc .chg{grid-template-columns:1fr}}\n<\/style>\n<div class=\"sbc\"><!-- 1 \u00b7 HERO -->\n<section id=\"top\" style=\"padding-top: 24px; padding-bottom: 56px\">\n<div class=\"wrap\">\n<nav class=\"crumb\" aria-label=\"Navega\u00e7\u00e3o estrutural\"><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 <b aria-current=\"page\">Dispositivos m\u00e9dicos<\/b><\/nav>\n<div class=\"g-hero\" style=\"margin-top: 24px\">\n<div class=\"hero-txt\" style=\"display: flex; flex-direction: column\">\n<p class=\"eye\">Consultoria regulat\u00f3ria \u00b7 Dispositivos m\u00e9dicos<\/p>\n<h1 class=\"h1\" style=\"margin-top: 20px\">Consultoria regulat\u00f3ria para <span class=\"gold\">dispositivos m\u00e9dicos<\/span>, da Anvisa \u00e0 exporta\u00e7\u00e3o<\/h1>\n<p class=\"lead\" style=\"margin-top: 24px\">Notifica\u00e7\u00e3o ou registro na Anvisa, Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o, altera\u00e7\u00f5es e renova\u00e7\u00f5es. E, quando for a hora, Europa, Reino Unido, Estados Unidos e Canad\u00e1. Planejamos a ordem, a via e os documentos para que o trabalho feito para um mercado <b>conte no pr\u00f3ximo<\/b>.<\/p>\n<p style=\"margin: 32px 0 12px; font: 600 15px 'Host Grotesk', system-ui, sans-serif; color: #051B5A\">Onde voc\u00ea quer vender?<\/p>\n<div class=\"mkbtns\" style=\"display: flex; flex-wrap: wrap; gap: 10px\">\n<a href=\"#markets\" class=\"mkbtn\" data-mk=\"BR\"><span class=\"flag\"><svg role=\"img\" aria-label=\"Flag of Brazil\" width=\"22\" height=\"15\" viewBox=\"0 0 30 21\"><rect width=\"30\" height=\"21\" fill=\"#009C3B\"><\/rect><path d=\"M15 2.5 27 10.5 15 18.5 3 10.5Z\" fill=\"#FFDF00\"><\/path><circle cx=\"15\" cy=\"10.5\" r=\"4.6\" fill=\"#002776\"><\/circle><\/svg><\/span> Brasil<\/a>\n<a href=\"#markets\" class=\"mkbtn\" data-mk=\"EU\"><span class=\"flag\"><svg role=\"img\" aria-label=\"Flag of the European Union\" width=\"22\" height=\"15\" viewBox=\"0 0 36 24\"><rect width=\"36\" height=\"24\" fill=\"#003399\"><\/rect><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(18.00,5.00)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(21.50,5.94)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(24.06,8.50)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(25.00,12.00)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(24.06,15.50)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(21.50,18.06)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(18.00,19.00)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(14.50,18.06)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(11.94,15.50)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(11.00,12.00)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(11.94,8.50)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(14.50,5.94)\"><\/path><\/svg><\/span> Europa<\/a>\n<a href=\"#markets\" class=\"mkbtn\" data-mk=\"UK\"><span class=\"flag\"><svg role=\"img\" aria-label=\"Flag of the United Kingdom\" width=\"22\" height=\"11\" viewBox=\"0 0 60 30\"><clipPath id=\"ukpd1\"><path d=\"M30,15 h30 v15 z v15 h-30 z h-30 v-15 z v-15 h30 z\"><\/path><\/clipPath><rect width=\"60\" height=\"30\" fill=\"#012169\"><\/rect><path d=\"M0,0 L60,30 M60,0 L0,30\" stroke=\"#FFFFFF\" stroke-width=\"6\"><\/path><path d=\"M0,0 L60,30 M60,0 L0,30\" clip-path=\"url(#ukpd1)\" stroke=\"#C8102E\" stroke-width=\"4\"><\/path><path d=\"M30,0 v30 M0,15 h60\" stroke=\"#FFFFFF\" stroke-width=\"10\"><\/path><path d=\"M30,0 v30 M0,15 h60\" stroke=\"#C8102E\" stroke-width=\"6\"><\/path><\/svg><\/span> Reino Unido<\/a>\n<a href=\"#markets\" class=\"mkbtn\" data-mk=\"US\"><span class=\"flag\"><svg role=\"img\" aria-label=\"Flag of the United States\" width=\"22\" height=\"15\" viewBox=\"0 0 38 26\"><rect width=\"38\" height=\"26\" fill=\"#FFFFFF\"><\/rect><path d=\"M0 0h38v2H0zM0 4h38v2H0zM0 8h38v2H0zM0 12h38v2H0zM0 16h38v2H0zM0 20h38v2H0zM0 24h38v2H0z\" fill=\"#B22234\"><\/path><rect width=\"16\" height=\"14\" fill=\"#3C3B6E\"><\/rect><\/svg><\/span> EUA<\/a>\n<a href=\"#markets\" class=\"mkbtn\" data-mk=\"CA\"><span class=\"flag\"><svg role=\"img\" aria-label=\"Flag of Canada\" width=\"22\" height=\"15\" viewBox=\"0 0 30 15\"><rect width=\"30\" height=\"15\" fill=\"#FFFFFF\"><\/rect><rect width=\"7.5\" height=\"15\" fill=\"#D52B1E\"><\/rect><rect x=\"22.5\" width=\"7.5\" height=\"15\" fill=\"#D52B1E\"><\/rect><path d=\"M15 3 16 5.6 17.6 5 17 8 18.6 7.6 18 9.4 15.6 9.6 15.6 12 14.4 12 14.4 9.6 12 9.4 11.4 7.6 13 8 12.4 5 14 5.6Z\" fill=\"#D52B1E\"><\/path><\/svg><\/span> Canad\u00e1<\/a>\n<\/div>\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/\" class=\"arrow\" style=\"align-self: flex-start; margin-top: 18px\">N\u00e3o sabe por onde come\u00e7ar? Monte sua rota no Sobel Route \u2192<\/a>\n<div class=\"seals\" style=\"display: grid; grid-template-columns: repeat(3, auto); gap: 12px 24px; margin-top: 32px; justify-content: start\">\n<span class=\"seal\" style=\"font-size: 14px\">Certificada ISO 9001 no Brasil<\/span><span class=\"seal\" style=\"font-size: 14px\">Liderada por ex-auditor de Organismo Notificado<\/span><span class=\"seal\" style=\"font-size: 14px\">Atendimento em PT \u00b7 EN \u00b7 DE<\/span>\n<\/div>\n<\/div>\n<div style=\"position: relative; border-radius: 22px; overflow: hidden; min-height: 470px\"><img decoding=\"async\" class=\"ph-img\" fetchpriority=\"high\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-md_in-use_pulse-oximeter_patient.webp\" alt=\"M\u00e3o com luva colocando um ox\u00edmetro no dedo do paciente\" style=\"position: absolute; inset: 0\"><\/div>\n<\/div>\n<\/div>\n<\/section>\n<!-- 1b \u00b7 IN SHORT (Google and AI) -->\n<section style=\"background: #FFFFFF; border-top: 1px solid #E7E1D7; border-bottom: 1px solid #E7E1D7; padding: 36px 0\">\n<div class=\"wrap\" style=\"display: grid; grid-template-columns: 220px minmax(0,1fr); gap: 32px; align-items: start\" >\n<div style=\"display: flex; flex-direction: column; gap: 8px\"><p class=\"eye\" style=\"font-size: 12px\">Em resumo<\/p><p style=\"margin: 0; font: 700 20px\/1.25 Lora, Georgia, serif; color: #051B5A\">Como funciona a regulariza\u00e7\u00e3o de dispositivos m\u00e9dicos<\/p><\/div>\n<div style=\"display: flex; flex-direction: column; gap: 10px\"><p class=\"body\" style=\"margin: 0\">No Brasil, o dispositivo m\u00e9dico \u00e9 classificado de I a IV pela RDC 751\/2022: classes I e II s\u00e3o notificadas, classes III e IV s\u00e3o registradas, e para III e IV a Anvisa exige o Certificado de Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o (RDC 665\/2022). O que serve em todos os mercados \u00e9 o n\u00facleo: sistema da qualidade ISO 13485, gerenciamento de risco ISO 14971, avalia\u00e7\u00e3o biol\u00f3gica e evid\u00eancia cl\u00ednica. A Sobel monta esse n\u00facleo uma vez e adapta para a Anvisa, o MDR europeu, o MHRA, o FDA e a Health Canada.<\/p><p style=\"margin: 0; font-size: 13px; color: #4F535B\">Atualizado em 31\/10\/2026 \u00b7 Revisado pela equipe regulat\u00f3ria da Sobel<\/p><\/div>\n<\/div>\n<\/section>\n<!-- 1c \u00b7 CLIENT LOGOS (as on the Home) -->\n<section aria-label=\"Clientes\" style=\"padding: 36px 0 8px\">\n<div class=\"wrap\" style=\"display: flex; flex-direction: column; align-items: center; gap: 22px\">\n<p style=\"margin: 0; font: 600 11px 'Host Grotesk', system-ui, sans-serif; letter-spacing: .16em; text-transform: uppercase; color: #8A8E96\">Fabricantes de dispositivos m\u00e9dicos no Brasil e no exterior confiam na Sobel<\/p>\n<div class=\"lgs\"><img decoding=\"async\" loading=\"lazy\" class=\"lg\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/1-1-rrwl48qx0mvye46ouibntcqo9zyw32bkjszjj8fu5k.png\" alt=\"S.I.N. logo\" style=\"animation-delay: 0.00s\"><img decoding=\"async\" loading=\"lazy\" class=\"lg\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/3-2-rrwl44zk9aqt3oc5ggp5jdotwghf89wn7adlm4leug.png\" alt=\"Dentsply Sirona logo\" style=\"animation-delay: 0.15s\"><img decoding=\"async\" loading=\"lazy\" class=\"lg\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/2-2-rrwl46v8mytdqw9f5hieod7r3885no43vjokkoimi0.png\" alt=\"Ortosintese logo\" style=\"animation-delay: 0.30s\"><img decoding=\"async\" loading=\"lazy\" class=\"lg\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/4-2-rrwl441q2gpis2dilyaiyvxdb2m20kswv5q44umt0o.png\" alt=\"CMOS Drake logo\" style=\"animation-delay: 0.45s\"><img decoding=\"async\" loading=\"lazy\" class=\"lg\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/6-rrwl40adb4kdhmiz7wo0owvixj4l5sdzin467qsdpk.png\" alt=\"MVision logo\" style=\"animation-delay: 0.60s\"><img decoding=\"async\" loading=\"lazy\" class=\"lg\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/oficial-2-scaled-rpdtcox4ez7lra7375z3ea92zuca7zgja37vu9rvqg.webp\" alt=\"Hydrumedical logo\" style=\"animation-delay: 0.75s\"><\/div>\n<\/div>\n<\/section>\n<!-- 1d \u00b7 QUAL \u00c9 O SEU CASO (3 perfis) -->\n<section class=\"sec\" style=\"padding-bottom: 24px\">\n<div class=\"wrap\">\n<div class=\"hd\"><p class=\"eye\">Qual \u00e9 o seu caso?<\/p><h2 class=\"h2\" style=\"margin-top: 0\">Comece pelo que voc\u00ea <span class=\"gold\">precisa agora<\/span><\/h2><\/div>\n<div class=\"g3\" style=\"margin-top: 36px\">\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/our-solutions-brazil\/\" class=\"card\" style=\"display: flex; flex-direction: column; gap: 14px; padding: 26px 26px 28px; text-decoration: none; border-top: 4px solid #2A72C8\"><span class=\"chip\" style=\"align-self: flex-start; background: #E3EEFB; color: #174A8C\">Fabricante no Brasil<\/span><h3 style=\"margin: 0; font: 700 22px\/1.3 Lora, Georgia, serif; color: #051B5A\">Vou regularizar meu produto na Anvisa<\/h3><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #2B2E34\">Do enquadramento ao protocolo, com o dossi\u00ea revisado antes de entrar na fila.<\/p><ul style=\"margin: 0; padding: 0; list-style: none; display: flex; flex-direction: column; gap: 8px; font-size: 15px; line-height: 1.5; color: #2B2E34\"><li style=\"display: flex; gap: 10px; align-items: flex-start\"><span style=\"flex: 0 0 8px; width: 8px; height: 8px; border-radius: 50%; background: #2A72C8; margin-top: 9px\"><\/span><span>Classifica\u00e7\u00e3o pela RDC 751\/2022 e escolha entre notifica\u00e7\u00e3o e registro<\/span><\/li><li style=\"display: flex; gap: 10px; align-items: flex-start\"><span style=\"flex: 0 0 8px; width: 8px; height: 8px; border-radius: 50%; background: #2A72C8; margin-top: 9px\"><\/span><span>Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o e Certificado de BPF para classes III e IV<\/span><\/li><li style=\"display: flex; gap: 10px; align-items: flex-start\"><span style=\"flex: 0 0 8px; width: 8px; height: 8px; border-radius: 50%; background: #2A72C8; margin-top: 9px\"><\/span><span>AFE, altera\u00e7\u00f5es, revalida\u00e7\u00f5es e tecnovigil\u00e2ncia<\/span><\/li><\/ul><span class=\"arrow\" style=\"align-self: flex-start; margin-top: auto\">Ver regulariza\u00e7\u00e3o na Anvisa \u2192<\/span><\/a>\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/our-solutions-brazil\/\" class=\"card\" style=\"display: flex; flex-direction: column; gap: 14px; padding: 26px 26px 28px; text-decoration: none; border-top: 4px solid #2A72C8\"><span class=\"chip\" style=\"align-self: flex-start; background: #E4F2E8; color: #1E6B3A\">Importador ou distribuidor<\/span><h3 style=\"margin: 0; font: 700 22px\/1.3 Lora, Georgia, serif; color: #051B5A\">Vou trazer um dispositivo de fora<\/h3><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #2B2E34\">A empresa que importa \u00e9 a detentora do registro e responde por ele na Anvisa.<\/p><ul style=\"margin: 0; padding: 0; list-style: none; display: flex; flex-direction: column; gap: 8px; font-size: 15px; line-height: 1.5; color: #2B2E34\"><li style=\"display: flex; gap: 10px; align-items: flex-start\"><span style=\"flex: 0 0 8px; width: 8px; height: 8px; border-radius: 50%; background: #2A72C8; margin-top: 9px\"><\/span><span>Dossi\u00ea montado a partir da documenta\u00e7\u00e3o do fabricante estrangeiro<\/span><\/li><li style=\"display: flex; gap: 10px; align-items: flex-start\"><span style=\"flex: 0 0 8px; width: 8px; height: 8px; border-radius: 50%; background: #2A72C8; margin-top: 9px\"><\/span><span>Certificado de BPF do fabricante e AFE da importadora<\/span><\/li><li style=\"display: flex; gap: 10px; align-items: flex-start\"><span style=\"flex: 0 0 8px; width: 8px; height: 8px; border-radius: 50%; background: #2A72C8; margin-top: 9px\"><\/span><span>Transfer\u00eancia de titularidade, com o dossi\u00ea conferido antes<\/span><\/li><\/ul><span class=\"arrow\" style=\"align-self: flex-start; margin-top: auto\">Ver registro de importados \u2192<\/span><\/a>\n<a href=\"#markets\" class=\"card\" style=\"display: flex; flex-direction: column; gap: 14px; padding: 26px 26px 28px; text-decoration: none; border-top: 4px solid #2A72C8\"><span class=\"chip\" style=\"align-self: flex-start; background: #FDF0CE; color: #7A5B00\">Quero exportar<\/span><h3 style=\"margin: 0; font: 700 22px\/1.3 Lora, Georgia, serif; color: #051B5A\">Vou vender na Europa, nos EUA ou no Canad\u00e1<\/h3><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #2B2E34\">Seu dossi\u00ea da Anvisa e seu sistema da qualidade s\u00e3o a base do pr\u00f3ximo mercado.<\/p><ul style=\"margin: 0; padding: 0; list-style: none; display: flex; flex-direction: column; gap: 8px; font-size: 15px; line-height: 1.5; color: #2B2E34\"><li style=\"display: flex; gap: 10px; align-items: flex-start\"><span style=\"flex: 0 0 8px; width: 8px; height: 8px; border-radius: 50%; background: #2A72C8; margin-top: 9px\"><\/span><span>Marca\u00e7\u00e3o CE pelo MDR, com a Sobel como sua Representante Autorizada na Europa<\/span><\/li><li style=\"display: flex; gap: 10px; align-items: flex-start\"><span style=\"flex: 0 0 8px; width: 8px; height: 8px; border-radius: 50%; background: #2A72C8; margin-top: 9px\"><\/span><span>FDA, com a Sobel como seu US Agent nos Estados Unidos<\/span><\/li><li style=\"display: flex; gap: 10px; align-items: flex-start\"><span style=\"flex: 0 0 8px; width: 8px; height: 8px; border-radius: 50%; background: #2A72C8; margin-top: 9px\"><\/span><span>MDSAP: uma auditoria que serve Anvisa, FDA e Health Canada<\/span><\/li><\/ul><span class=\"arrow\" style=\"align-self: flex-start; margin-top: auto\">Ver os mercados \u2192<\/span><\/a>\n<\/div>\n<\/div>\n<\/section>\n<!-- 2 \u00b7 THE FOUR MARKETS (interactive) -->\n<section id=\"markets\" class=\"sec\">\n<div class=\"wrap\">\n<div class=\"hd\"><p class=\"eye\">Seus mercados<\/p><h2 class=\"h2\" style=\"margin-top: 0\">O que cada mercado <span class=\"gold\">exige<\/span><\/h2><p class=\"body\">Escolha um mercado para ver as classes de risco, a via de aprova\u00e7\u00e3o, quem precisa estar no pa\u00eds e o sistema da qualidade exigido.<\/p><\/div>\n<div role=\"tablist\" aria-label=\"Mercados\" class=\"mkbtns\" style=\"display: flex; flex-wrap: wrap; gap: 10px; margin-top: 32px\">\n<button type=\"button\" class=\"mkbtn on\" data-mk=\"BR\" role=\"tab\" aria-selected=\"true\" aria-controls=\"mk-BR\"><span class=\"flag\"><svg role=\"img\" aria-label=\"Flag of Brazil\" width=\"22\" height=\"15\" viewBox=\"0 0 30 21\"><rect width=\"30\" height=\"21\" fill=\"#009C3B\"><\/rect><path d=\"M15 2.5 27 10.5 15 18.5 3 10.5Z\" fill=\"#FFDF00\"><\/path><circle cx=\"15\" cy=\"10.5\" r=\"4.6\" fill=\"#002776\"><\/circle><\/svg><\/span> Brasil \u00b7 Anvisa<\/button>\n<button type=\"button\" class=\"mkbtn\" data-mk=\"EU\" role=\"tab\" aria-selected=\"false\" aria-controls=\"mk-EU\"><span class=\"flag\"><svg role=\"img\" aria-label=\"Flag of the European Union\" width=\"22\" height=\"15\" viewBox=\"0 0 36 24\"><rect width=\"36\" height=\"24\" fill=\"#003399\"><\/rect><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(18.00,5.00)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(21.50,5.94)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(24.06,8.50)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(25.00,12.00)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(24.06,15.50)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(21.50,18.06)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(18.00,19.00)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(14.50,18.06)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(11.94,15.50)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(11.00,12.00)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(11.94,8.50)\"><\/path><path d=\"M0,-1.4 L0.33,-0.45 1.33,-0.43 0.53,0.17 0.82,1.13 0,0.56 -0.82,1.13 -0.53,0.17 -1.33,-0.43 -0.33,-0.45Z\" fill=\"#FFCC00\" transform=\"translate(14.50,5.94)\"><\/path><\/svg><\/span> Europa \u00b7 MDR<\/button>\n<button type=\"button\" class=\"mkbtn\" data-mk=\"UK\" role=\"tab\" aria-selected=\"false\" aria-controls=\"mk-UK\"><span class=\"flag\"><svg role=\"img\" aria-label=\"Flag of the United Kingdom\" width=\"22\" height=\"11\" viewBox=\"0 0 60 30\"><clipPath id=\"ukpd2\"><path d=\"M30,15 h30 v15 z v15 h-30 z h-30 v-15 z v-15 h30 z\"><\/path><\/clipPath><rect width=\"60\" height=\"30\" fill=\"#012169\"><\/rect><path d=\"M0,0 L60,30 M60,0 L0,30\" stroke=\"#FFFFFF\" stroke-width=\"6\"><\/path><path d=\"M0,0 L60,30 M60,0 L0,30\" clip-path=\"url(#ukpd2)\" stroke=\"#C8102E\" stroke-width=\"4\"><\/path><path d=\"M30,0 v30 M0,15 h60\" stroke=\"#FFFFFF\" stroke-width=\"10\"><\/path><path d=\"M30,0 v30 M0,15 h60\" stroke=\"#C8102E\" stroke-width=\"6\"><\/path><\/svg><\/span> Reino Unido \u00b7 MHRA<\/button>\n<button type=\"button\" class=\"mkbtn\" data-mk=\"US\" role=\"tab\" aria-selected=\"false\" aria-controls=\"mk-US\"><span class=\"flag\"><svg role=\"img\" aria-label=\"Flag of the United States\" width=\"22\" height=\"15\" viewBox=\"0 0 38 26\"><rect width=\"38\" height=\"26\" fill=\"#FFFFFF\"><\/rect><path d=\"M0 0h38v2H0zM0 4h38v2H0zM0 8h38v2H0zM0 12h38v2H0zM0 16h38v2H0zM0 20h38v2H0zM0 24h38v2H0z\" fill=\"#B22234\"><\/path><rect width=\"16\" height=\"14\" fill=\"#3C3B6E\"><\/rect><\/svg><\/span> Estados Unidos \u00b7 FDA<\/button>\n<button type=\"button\" class=\"mkbtn\" data-mk=\"CA\" role=\"tab\" aria-selected=\"false\" aria-controls=\"mk-CA\"><span class=\"flag\"><svg role=\"img\" aria-label=\"Flag of Canada\" width=\"22\" height=\"15\" viewBox=\"0 0 30 15\"><rect width=\"30\" height=\"15\" fill=\"#FFFFFF\"><\/rect><rect width=\"7.5\" height=\"15\" fill=\"#D52B1E\"><\/rect><rect x=\"22.5\" width=\"7.5\" height=\"15\" fill=\"#D52B1E\"><\/rect><path d=\"M15 3 16 5.6 17.6 5 17 8 18.6 7.6 18 9.4 15.6 9.6 15.6 12 14.4 12 14.4 9.6 12 9.4 11.4 7.6 13 8 12.4 5 14 5.6Z\" fill=\"#D52B1E\"><\/path><\/svg><\/span> Canad\u00e1 \u00b7 Health Canada<\/button>\n<\/div>\n<div class=\"mkpanel\" id=\"mk-BR\" role=\"tabpanel\" data-panel=\"BR\" style=\"margin-top: 20px\">\n<div style=\"padding: 32px 36px; display: flex; flex-direction: column\">\n<p class=\"eye\" style=\"font-size: 12px\">Brasil \u00b7 Anvisa<\/p>\n<h3 class=\"h3\" style=\"margin-top: 14px; font-size: 28px\">Dispositivos m\u00e9dicos no Brasil<\/h3>\n<div style=\"margin-top: 18px\">\n<div class=\"mkrow\"><b>Classes de risco<\/b><span>I, II, III e IV (RDC 751\/2022)<\/span><\/div>\n<div class=\"mkrow\"><b>Via<\/b><span>Notifica\u00e7\u00e3o para classes I e II; registro para classes III e IV<\/span><\/div>\n<div class=\"mkrow\"><b>Presen\u00e7a local<\/b><span>O detentor do registro \u00e9 uma empresa brasileira: o pr\u00f3prio fabricante ou o importador, com AFE. Para fabricantes no exterior, a Sobel oferece o detentor por meio de parceiro homologado.<\/span><\/div>\n<div class=\"mkrow\"><b>Sistema da qualidade<\/b><span>Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o (RDC 665\/2022); Certificado de BPF da Anvisa para classes III e IV<\/span><\/div>\n<\/div>\n<\/div>\n<div style=\"background: #051B5A; color: #FFFFFF; padding: 32px 32px; display: flex; flex-direction: column; gap: 16px\">\n<p class=\"eye lt\" style=\"font-size: 12px\">Como a Sobel ajuda<\/p>\n<p style=\"margin: 0; font: 600 22px\/1.35 Lora, Georgia, serif\">Classifica\u00e7\u00e3o, dossi\u00ea, certifica\u00e7\u00e3o de BPF, altera\u00e7\u00f5es e respostas a exig\u00eancias, com a mesma equipe do come\u00e7o ao fim.<\/p>\n<div style=\"background: rgba(255,255,255,.08); border: 1px solid rgba(255,255,255,.18); border-radius: 12px; padding: 14px 16px; font-size: 15px; line-height: 1.5; color: #DCE4FF\"><b style=\"color: #F2B705\">J\u00e1 est\u00e1 em outro mercado?<\/b> Se o produto j\u00e1 tem marca\u00e7\u00e3o CE ou FDA, o dossi\u00ea t\u00e9cnico, o gerenciamento de risco e a avalia\u00e7\u00e3o biol\u00f3gica viram a base do processo na Anvisa.<\/div>\n<div style=\"display: flex; gap: 12px; align-items: flex-start; border-top: 1px solid rgba(255,255,255,.18); padding-top: 16px\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"2\" aria-hidden=\"true\" style=\"flex: 0 0 22px; margin-top: 2px\"><path d=\"M21 12a9 9 0 1 1-3-6.7\"><\/path><path d=\"M21 4v5h-5\"><\/path><\/svg><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #DCE4FF\"><b style=\"color: #FFFFFF\">Suporte cont\u00ednuo:<\/b> mantenha a Sobel como sua equipe regulat\u00f3ria no Brasil, com um escopo mensal para altera\u00e7\u00f5es, revalida\u00e7\u00f5es, exig\u00eancias e tecnovigil\u00e2ncia. <a href=\"https:\/\/sobelconsult.com\/pt-br\/como-trabalhamos\/#shw-ongoing\" style=\"color: #F2B705; font-weight: 600; text-decoration: none\">Como funciona \u2192<\/a><\/p><\/div>\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/our-solutions-brazil\/\" class=\"btn-gold\" style=\"align-self: flex-start; margin-top: auto\">Regulariza\u00e7\u00e3o na Anvisa<\/a>\n<\/div>\n<\/div>\n<div class=\"mkpanel\" id=\"mk-EU\" role=\"tabpanel\" data-panel=\"EU\" style=\"margin-top: 20px\" hidden>\n<div style=\"padding: 32px 36px; display: flex; flex-direction: column\">\n<p class=\"eye\" style=\"font-size: 12px\">Europa \u00b7 MDR<\/p>\n<h3 class=\"h3\" style=\"margin-top: 14px; font-size: 28px\">Dispositivos m\u00e9dicos na Uni\u00e3o Europeia<\/h3>\n<div style=\"margin-top: 18px\">\n<div class=\"mkrow\"><b>Classes de risco<\/b><span>I, IIa, IIb e III (MDR, Anexo VIII)<\/span><\/div>\n<div class=\"mkrow\"><b>Via<\/b><span>Marca\u00e7\u00e3o CE: autodeclara\u00e7\u00e3o para a maior parte da classe I; avalia\u00e7\u00e3o por Organismo Notificado para as demais<\/span><\/div>\n<div class=\"mkrow\"><b>Presen\u00e7a local<\/b><span>Representante Autorizado na UE para fabricantes de fora, al\u00e9m do cadastro no EUDAMED. A Sobel atua como sua Representante Autorizada com a empresa pr\u00f3pria na Europa.<\/span><\/div>\n<div class=\"mkrow\"><b>Sistema da qualidade<\/b><span>Sistema da qualidade com base na ISO 13485, auditado pelo Organismo Notificado<\/span><\/div>\n<\/div>\n<\/div>\n<div style=\"background: #051B5A; color: #FFFFFF; padding: 32px 32px; display: flex; flex-direction: column; gap: 16px\">\n<p class=\"eye lt\" style=\"font-size: 12px\">Como a Sobel ajuda<\/p>\n<p style=\"margin: 0; font: 600 22px\/1.35 Lora, Georgia, serif\">Documenta\u00e7\u00e3o t\u00e9cnica, avalia\u00e7\u00e3o cl\u00ednica, o processo com o Organismo Notificado e a sua Representante Autorizada, com uma equipe s\u00f3.<\/p>\n<div style=\"background: rgba(255,255,255,.08); border: 1px solid rgba(255,255,255,.18); border-radius: 12px; padding: 14px 16px; font-size: 15px; line-height: 1.5; color: #DCE4FF\"><b style=\"color: #F2B705\">J\u00e1 est\u00e1 em outro mercado?<\/b> O dossi\u00ea da Anvisa traz os ensaios e o gerenciamento de risco; o MDR pede mais evid\u00eancia cl\u00ednica.<\/div>\n<div style=\"display: flex; gap: 12px; align-items: flex-start; border-top: 1px solid rgba(255,255,255,.18); padding-top: 16px\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"2\" aria-hidden=\"true\" style=\"flex: 0 0 22px; margin-top: 2px\"><path d=\"M21 12a9 9 0 1 1-3-6.7\"><\/path><path d=\"M21 4v5h-5\"><\/path><\/svg><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #DCE4FF\"><b style=\"color: #FFFFFF\">Suporte cont\u00ednuo:<\/b> mantenha a Sobel como sua equipe regulat\u00f3ria na Europa, com um escopo mensal para atualizar a documenta\u00e7\u00e3o t\u00e9cnica, responder ao Organismo Notificado e fazer a vigil\u00e2ncia p\u00f3s-mercado. <a href=\"https:\/\/sobelconsult.com\/pt-br\/como-trabalhamos\/#shw-ongoing\" style=\"color: #F2B705; font-weight: 600; text-decoration: none\">Como funciona \u2192<\/a><\/p><\/div>\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/suporte-registro-mdr\/\" class=\"btn-gold\" style=\"align-self: flex-start; margin-top: auto\">Dispositivos m\u00e9dicos na Europa<\/a>\n<\/div>\n<\/div>\n<div class=\"mkpanel\" id=\"mk-UK\" role=\"tabpanel\" data-panel=\"UK\" style=\"margin-top: 20px\" hidden>\n<div style=\"padding: 32px 36px; display: flex; flex-direction: column\">\n<p class=\"eye\" style=\"font-size: 12px\">Reino Unido \u00b7 MHRA<\/p>\n<h3 class=\"h3\" style=\"margin-top: 14px; font-size: 28px\">Dispositivos m\u00e9dicos na Gr\u00e3-Bretanha<\/h3>\n<div style=\"margin-top: 18px\">\n<div class=\"mkrow\"><b>Classes de risco<\/b><span>I, IIa, IIb e III (UK MDR 2002)<\/span><\/div>\n<div class=\"mkrow\"><b>Via<\/b><span>Marca\u00e7\u00e3o UKCA, com um UK Approved Body para tudo, exceto a classe I autocertificada; produtos com CE pelo MDR s\u00e3o aceitos at\u00e9 30\/06\/2030<\/span><\/div>\n<div class=\"mkrow\"><b>Presen\u00e7a local<\/b><span>UK Responsible Person para fabricantes de fora, que registra os dispositivos no MHRA. A Sobel oferece por meio de parceiro homologado.<\/span><\/div>\n<div class=\"mkrow\"><b>Sistema da qualidade<\/b><span>Sistema da qualidade com base na ISO 13485, avaliado pelo UK Approved Body para a UKCA<\/span><\/div>\n<\/div>\n<\/div>\n<div style=\"background: #051B5A; color: #FFFFFF; padding: 32px 32px; display: flex; flex-direction: column; gap: 16px\">\n<p class=\"eye lt\" style=\"font-size: 12px\">Como a Sobel ajuda<\/p>\n<p style=\"margin: 0; font: 600 22px\/1.35 Lora, Georgia, serif\">A via de entrada na Gr\u00e3-Bretanha (CE ou UKCA), o registro no MHRA e a UK Responsible Person por meio do nosso parceiro.<\/p>\n<div style=\"background: rgba(255,255,255,.08); border: 1px solid rgba(255,255,255,.18); border-radius: 12px; padding: 14px 16px; font-size: 15px; line-height: 1.5; color: #DCE4FF\"><b style=\"color: #F2B705\">J\u00e1 est\u00e1 em outro mercado?<\/b> O dossi\u00ea do MDR e o certificado CE valem na Gr\u00e3-Bretanha at\u00e9 30\/06\/2030; a UKCA usa a mesma documenta\u00e7\u00e3o t\u00e9cnica.<\/div>\n<div style=\"display: flex; gap: 12px; align-items: flex-start; border-top: 1px solid rgba(255,255,255,.18); padding-top: 16px\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"2\" aria-hidden=\"true\" style=\"flex: 0 0 22px; margin-top: 2px\"><path d=\"M21 12a9 9 0 1 1-3-6.7\"><\/path><path d=\"M21 4v5h-5\"><\/path><\/svg><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #DCE4FF\"><b style=\"color: #FFFFFF\">Suporte cont\u00ednuo:<\/b> mantenha a Sobel como sua equipe regulat\u00f3ria para o Reino Unido, com um escopo mensal para registros no MHRA, altera\u00e7\u00f5es e vigil\u00e2ncia p\u00f3s-mercado. <a href=\"https:\/\/sobelconsult.com\/pt-br\/como-trabalhamos\/#shw-ongoing\" style=\"color: #F2B705; font-weight: 600; text-decoration: none\">Como funciona \u2192<\/a><\/p><\/div>\n<a href=\"#footer-cta\" class=\"btn-gold\" style=\"align-self: flex-start; margin-top: auto\">Falar sobre o Reino Unido<\/a>\n<\/div>\n<\/div>\n<div class=\"mkpanel\" id=\"mk-US\" role=\"tabpanel\" data-panel=\"US\" style=\"margin-top: 20px\" hidden>\n<div style=\"padding: 32px 36px; display: flex; flex-direction: column\">\n<p class=\"eye\" style=\"font-size: 12px\">Estados Unidos \u00b7 FDA<\/p>\n<h3 class=\"h3\" style=\"margin-top: 14px; font-size: 28px\">Dispositivos m\u00e9dicos nos Estados Unidos<\/h3>\n<div style=\"margin-top: 18px\">\n<div class=\"mkrow\"><b>Classes de risco<\/b><span>I, II e III (21 CFR 860)<\/span><\/div>\n<div class=\"mkrow\"><b>Via<\/b><span>510(k), De Novo ou PMA, conforme a classe e o produto de refer\u00eancia; muitos da classe I s\u00e3o isentos<\/span><\/div>\n<div class=\"mkrow\"><b>Presen\u00e7a local<\/b><span>US Agent para empresas de fora, al\u00e9m do registro do estabelecimento e da listagem dos produtos todo ano. A Sobel atua como seu US Agent com a empresa pr\u00f3pria nos EUA.<\/span><\/div>\n<div class=\"mkrow\"><b>Sistema da qualidade<\/b><span>QMSR (21 CFR Parte 820), alinhado \u00e0 ISO 13485 desde 02\/02\/2026<\/span><\/div>\n<\/div>\n<\/div>\n<div style=\"background: #051B5A; color: #FFFFFF; padding: 32px 32px; display: flex; flex-direction: column; gap: 16px\">\n<p class=\"eye lt\" style=\"font-size: 12px\">Como a Sobel ajuda<\/p>\n<p style=\"margin: 0; font: 600 22px\/1.35 Lora, Georgia, serif\">Estrat\u00e9gia de via, o dossi\u00ea do 510(k) ou De Novo, registro e listagem, e o seu US Agent, com uma equipe s\u00f3.<\/p>\n<div style=\"background: rgba(255,255,255,.08); border: 1px solid rgba(255,255,255,.18); border-radius: 12px; padding: 14px 16px; font-size: 15px; line-height: 1.5; color: #DCE4FF\"><b style=\"color: #F2B705\">J\u00e1 est\u00e1 em outro mercado?<\/b> O sistema ISO 13485 e os relat\u00f3rios de ensaio aproveitam; o FDA acrescenta a l\u00f3gica de via e a compara\u00e7\u00e3o com o produto de refer\u00eancia.<\/div>\n<div style=\"display: flex; gap: 12px; align-items: flex-start; border-top: 1px solid rgba(255,255,255,.18); padding-top: 16px\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"2\" aria-hidden=\"true\" style=\"flex: 0 0 22px; margin-top: 2px\"><path d=\"M21 12a9 9 0 1 1-3-6.7\"><\/path><path d=\"M21 4v5h-5\"><\/path><\/svg><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #DCE4FF\"><b style=\"color: #FFFFFF\">Suporte cont\u00ednuo:<\/b> mantenha a Sobel como sua equipe regulat\u00f3ria nos EUA, com um escopo mensal para o registro anual, altera\u00e7\u00f5es e perguntas do FDA. <a href=\"https:\/\/sobelconsult.com\/pt-br\/como-trabalhamos\/#shw-ongoing\" style=\"color: #F2B705; font-weight: 600; text-decoration: none\">Como funciona \u2192<\/a><\/p><\/div>\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/\" class=\"btn-gold\" style=\"align-self: flex-start; margin-top: auto\">Dispositivos m\u00e9dicos nos EUA<\/a>\n<\/div>\n<\/div>\n<div class=\"mkpanel\" id=\"mk-CA\" role=\"tabpanel\" data-panel=\"CA\" style=\"margin-top: 20px\" hidden>\n<div style=\"padding: 32px 36px; display: flex; flex-direction: column\">\n<p class=\"eye\" style=\"font-size: 12px\">Canad\u00e1 \u00b7 Health Canada<\/p>\n<h3 class=\"h3\" style=\"margin-top: 14px; font-size: 28px\">Dispositivos m\u00e9dicos no Canad\u00e1<\/h3>\n<div style=\"margin-top: 18px\">\n<div class=\"mkrow\"><b>Classes de risco<\/b><span>I, II, III e IV (SOR\/98-282)<\/span><\/div>\n<div class=\"mkrow\"><b>Via<\/b><span>Medical Device Licence (MDL) para classes II a IV; classe I vendida com licen\u00e7a de estabelecimento (MDEL)<\/span><\/div>\n<div class=\"mkrow\"><b>Presen\u00e7a local<\/b><span>N\u00e3o exige representante local; importadores e distribuidores t\u00eam MDEL<\/span><\/div>\n<div class=\"mkrow\"><b>Sistema da qualidade<\/b><span>Certificado MDSAP para classes II a IV<\/span><\/div>\n<\/div>\n<\/div>\n<div style=\"background: #051B5A; color: #FFFFFF; padding: 32px 32px; display: flex; flex-direction: column; gap: 16px\">\n<p class=\"eye lt\" style=\"font-size: 12px\">Como a Sobel ajuda<\/p>\n<p style=\"margin: 0; font: 600 22px\/1.35 Lora, Georgia, serif\">Classifica\u00e7\u00e3o, o pedido de licen\u00e7a e a prepara\u00e7\u00e3o para o MDSAP, alinhados aos seus outros mercados.<\/p>\n<div style=\"background: rgba(255,255,255,.08); border: 1px solid rgba(255,255,255,.18); border-radius: 12px; padding: 14px 16px; font-size: 15px; line-height: 1.5; color: #DCE4FF\"><b style=\"color: #F2B705\">J\u00e1 est\u00e1 em outro mercado?<\/b> A auditoria MDSAP tamb\u00e9m serve para a Anvisa e o FDA: uma auditoria, v\u00e1rios mercados.<\/div>\n<div style=\"display: flex; gap: 12px; align-items: flex-start; border-top: 1px solid rgba(255,255,255,.18); padding-top: 16px\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"2\" aria-hidden=\"true\" style=\"flex: 0 0 22px; margin-top: 2px\"><path d=\"M21 12a9 9 0 1 1-3-6.7\"><\/path><path d=\"M21 4v5h-5\"><\/path><\/svg><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #DCE4FF\"><b style=\"color: #FFFFFF\">Suporte cont\u00ednuo:<\/b> mantenha a Sobel como sua equipe regulat\u00f3ria no Canad\u00e1, com um escopo mensal para altera\u00e7\u00f5es de licen\u00e7a, acompanhamento do MDSAP e perguntas da Health Canada. <a href=\"https:\/\/sobelconsult.com\/pt-br\/como-trabalhamos\/#shw-ongoing\" style=\"color: #F2B705; font-weight: 600; text-decoration: none\">Como funciona \u2192<\/a><\/p><\/div>\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/suporte-regulatorio-health-canada\/\" class=\"btn-gold\" style=\"align-self: flex-start; margin-top: auto\">Dispositivos m\u00e9dicos no Canad\u00e1<\/a>\n<\/div>\n<\/div>\n<p style=\"margin: 14px 0 0; font-size: 13px; line-height: 1.55; color: #4F535B\">Fontes: Anvisa RDC 751\/2022 e RDC 665\/2022; Regulamento (UE) 2017\/745; FDA 21 CFR Partes 807, 814, 820 e 860; UK Medical Devices Regulations 2002 e guia do MHRA (atualizado em 20\/02\/2026); Medical Devices Regulations da Health Canada (SOR\/98-282). Vis\u00e3o geral, n\u00e3o \u00e9 parecer jur\u00eddico: a classe e a via do seu produto s\u00e3o confirmadas no seu plano.<\/p>\n<\/div>\n<\/section>\n<!-- 7 \u00b7 NUMBERS WITH A STORY (3 small charts) -->\n<section class=\"sec\" style=\"background: #FFFFFF\">\n<div class=\"wrap\">\n<div class=\"hd\"><p class=\"eye\">Os n\u00fameros por tr\u00e1s do seu prazo<\/p><h2 class=\"h2\" style=\"margin-top: 0\">O tempo de an\u00e1lise \u00e9 da ag\u00eancia. <span class=\"gold\">O seu dossi\u00ea<\/span> depende de voc\u00ea.<\/h2><\/div>\n<div class=\"story\" style=\"margin-top: 40px\">\n<div class=\"st\"><span class=\"k\">Brasil \u00b7 Anvisa<\/span><h3>Na Anvisa, a maior parte dos indeferimentos come\u00e7a no papel<\/h3><div class=\"why\"><div class=\"grp\"><p class=\"wl\">Classes I e II <em>Notifica\u00e7\u00e3o<\/em><\/p><ul><li>Falta de formul\u00e1rio, certificado ou carta de autoriza\u00e7\u00e3o<\/li><li>Documento estrangeiro sem apostilamento<\/li><li>Fabricante diferente entre os documentos<\/li><li>Erro de classifica\u00e7\u00e3o ou de agrupamento<\/li><\/ul><\/div><div class=\"grp\"><p class=\"wl\">Classes III e IV <em>Registro<\/em><\/p><ul><li>Evid\u00eancia cl\u00ednica insuficiente<\/li><li>Gerenciamento de risco incompleto<\/li><li>Lacunas na avalia\u00e7\u00e3o biol\u00f3gica e na estabilidade<\/li><li>Rotulagem, instru\u00e7\u00f5es de uso e Certificado de BPF<\/li><\/ul><\/div><\/div><p style=\"margin: 0; font-size: 15px; line-height: 1.5\"><b>77 processos de 55 empresas<\/b> indeferidos numa \u00fanica resolu\u00e7\u00e3o. Cada um volta para uma fila de an\u00e1lise que j\u00e1 pode levar de 9 a 12 meses.<\/p><p class=\"src\">Motivos apresentados pelas \u00e1reas t\u00e9cnicas da Anvisa (GEMAT, GGTPS) no painel da ABIMO, Hospitalar 2026; Resolu\u00e7\u00e3o-RE n\u00ba 2.804, de 16\/07\/2026; fila: dados da GGTPS de 2024, ABIMED.<\/p><\/div>\n<div class=\"st\"><span class=\"k\">Europa \u00b7 MDR<\/span><h3>Metade dos novos certificados MDR leva de 13 a 18 meses<\/h3>\n<div class=\"bars\"><div class=\"b\"><em>14%<\/em><i style=\"height: 29%\"><\/i><span>at\u00e9 6 meses<\/span><\/div><div class=\"b\"><em>17%<\/em><i style=\"height: 35%\"><\/i><span>6 a 12<\/span><\/div><div class=\"b hi\"><em>48%<\/em><i style=\"height: 100%\"><\/i><span>13 a 18<\/span><\/div><div class=\"b\"><em>7%<\/em><i style=\"height: 15%\"><\/i><span>mais de 24<\/span><\/div><\/div>\n<p style=\"margin: 0; font-size: 15px; line-height: 1.5\">A demanda segue alta: <b>13.953 certificados<\/b> em 2025, para 25.978 pedidos, em 52 Organismos Notificados.<\/p>\n<p class=\"src\">Team-NB, Medical Device Survey 2025 (41 de 52 Organismos Notificados), novos certificados MDR.<\/p><\/div>\n<div class=\"st\"><span class=\"k\">Estados Unidos \u00b7 FDA<\/span><h3>Dos 21.780 pedidos ao FDA em 2025, 124 eram dispositivos in\u00e9ditos<\/h3>\n<div class=\"fun\"><div class=\"fr\"><div class=\"lb\"><b>21.780<\/b> pedidos recebidos<\/div><div class=\"br\"><i style=\"width: 100%\"><\/i><\/div><\/div><div class=\"fr\"><div class=\"lb\"><b>5.640<\/b> autorizados<\/div><div class=\"br\"><i style=\"width: 26%\"><\/i><\/div><\/div><div class=\"fr hi\"><div class=\"lb\"><b>124<\/b> in\u00e9ditos<\/div><div class=\"br\"><i style=\"width: 3%\"><\/i><\/div><\/div><\/div>\n<p style=\"margin: 0; font-size: 15px; line-height: 1.5\">A maioria entra nos EUA por uma via j\u00e1 existente. <b>Escolher a via certa<\/b> \u00e9 a primeira decis\u00e3o.<\/p>\n<p class=\"src\">FDA, relat\u00f3rio anual do CDRH 2025.<\/p><\/div>\n<\/div>\n<div style=\"margin-top: 28px; display: flex; flex-wrap: wrap; gap: 16px 24px; align-items: center; justify-content: space-between; background: #FDF0CE; border-radius: 16px; padding: 20px 24px\">\n<p style=\"margin: 0; font-size: 17px; line-height: 1.5; color: #2B2E34; flex: 1 1 520px\">Ningu\u00e9m encurta a fila da Anvisa. O que d\u00e1 para fazer \u00e9 <b>entrar nela com o dossi\u00ea completo<\/b>, para reduzir o risco de exig\u00eancia e de indeferimento.<\/p>\n<a href=\"#footer-cta\" class=\"btn-gold\">Agendar avalia\u00e7\u00e3o<\/a>\n<\/div>\n<div class=\"chg\"><svg width=\"26\" height=\"26\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"2\" aria-hidden=\"true\"><path d=\"M21 12a9 9 0 1 1-3-6.7\"><\/path><path d=\"M21 4v5h-5\"><\/path><\/svg><p><b>As regras mudam, e ningu\u00e9m avisa voc\u00ea.<\/b> A RDC 751\/2022 substituiu a RDC 185\/2001, a RDC 665\/2022 refez as Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o e a ISO 10993-1:2025 virou ABNT NBR. No suporte cont\u00ednuo, a Sobel acompanha as mudan\u00e7as da Anvisa que afetam o seu portf\u00f3lio e avisa o que fazer, antes que uma inspe\u00e7\u00e3o ou uma revalida\u00e7\u00e3o mostre.<\/p><a href=\"https:\/\/sobelconsult.com\/pt-br\/como-trabalhamos\/#shw-ongoing\">Como funciona o suporte cont\u00ednuo \u2192<\/a><\/div>\n<\/div>\n<\/section>\n<!-- 4 \u00b7 START FROM WHAT YOU HAVE -->\n<section class=\"sec\" style=\"background: #051B5A; color: #FFFFFF\">\n<div class=\"wrap\">\n<div class=\"g-split\" style=\"align-items: start\">\n<div style=\"display: flex; flex-direction: column\">\n<p class=\"eye lt\">J\u00e1 tem registro na Anvisa?<\/p>\n<h2 class=\"h2\" style=\"color: #FFFFFF; margin-top: 20px\">Voc\u00ea n\u00e3o come\u00e7a <span class=\"gold\">do zero<\/span><\/h2>\n<p class=\"body\" style=\"color: #DCE4FF; margin-top: 24px\">Boa parte do seu dossi\u00ea viaja. Conferimos o que voc\u00ea j\u00e1 tem e mostramos o que se aproveita, o que precisa ser adaptado e o que \u00e9 novo, antes de voc\u00ea investir no pr\u00f3ximo mercado.<\/p>\n<div style=\"border-radius: 18px; overflow: hidden; height: 250px; margin-top: 32px\"><img decoding=\"async\" loading=\"lazy\" class=\"ph-img\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-md_prototype-on-technical-drawing_oximeter.webp\" alt=\"Prot\u00f3tipo de ox\u00edmetro sobre um desenho t\u00e9cnico\"><\/div>\n<\/div>\n<div style=\"display: flex; flex-direction: column; gap: 16px\">\n<div class=\"reuse\">\n<div class=\"c\" style=\"background: #FFFFFF; color: #2B2E34\"><span class=\"chip\" style=\"align-self: flex-start; background: #E3EEFB; color: #174A8C\">Aproveita<\/span><ul><li>Sistema da qualidade ISO 13485<\/li><li>Gerenciamento de risco ISO 14971<\/li><li>Avalia\u00e7\u00e3o biol\u00f3gica (ISO 10993)<\/li><li>Relat\u00f3rios de ensaio e dados cl\u00ednicos<\/li><\/ul><\/div>\n<div class=\"c\" style=\"background: #FFFFFF; color: #2B2E34\"><span class=\"chip\" style=\"align-self: flex-start; background: #FDF0CE; color: #7A5B00\">Adapta<\/span><ul><li>Classifica\u00e7\u00e3o em cada mercado<\/li><li>Formato da avalia\u00e7\u00e3o cl\u00ednica<\/li><li>R\u00f3tulos, instru\u00e7\u00f5es de uso e idioma<\/li><\/ul><\/div>\n<div class=\"c\" style=\"background: #FFFFFF; color: #2B2E34\"><span class=\"chip\" style=\"align-self: flex-start; background: #FBE7E4; color: #9A2B1E\">Novo<\/span><ul><li>Representante ou agente local<\/li><li>Formul\u00e1rios e taxas de cada pa\u00eds<\/li><li>Cadastros nas bases de dados<\/li><\/ul><\/div>\n<\/div>\n<div style=\"background: rgba(255,255,255,.08); border: 1px solid rgba(255,255,255,.2); border-radius: 16px; padding: 22px; display: flex; flex-direction: column; gap: 12px\">\n<p style=\"margin: 0; font: 600 20px\/1.35 Lora, Georgia, serif\">Exemplo: registrado na Anvisa, agora Europa<\/p>\n<p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #DCE4FF\">Seu dossi\u00ea t\u00e9cnico, o gerenciamento de risco e a avalia\u00e7\u00e3o biol\u00f3gica s\u00e3o a base. O MDR pede mais evid\u00eancia cl\u00ednica, a avalia\u00e7\u00e3o de um Organismo Notificado, o cadastro no EUDAMED e um Representante Autorizado na UE, papel que a Sobel assume com a empresa pr\u00f3pria na Europa.<\/p>\n<\/div>\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/\" class=\"btn-gold\" style=\"align-self: flex-start\">Montar minha rota no Sobel Route<\/a>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<!-- 5 \u00b7 WHAT SOBEL DOES FOR MEDICAL DEVICES (two pillars) -->\n<section class=\"sec\">\n<div class=\"wrap\">\n<div class=\"hd\"><p class=\"eye\">O que fazemos em dispositivos m\u00e9dicos<\/p><h2 class=\"h2\" style=\"margin-top: 0\">Duas equipes, um <span class=\"gold\">dossi\u00ea<\/span><\/h2><p class=\"body\">A estrat\u00e9gia regulat\u00f3ria e a evid\u00eancia de seguran\u00e7a que a sustenta, planejadas juntas para que o avaliador veja uma hist\u00f3ria s\u00f3. Escolha uma equipe para ver como funciona.<\/p><\/div>\n<div class=\"g2\" style=\"margin-top: 40px\">\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/regulatorio-qualidade\/\" class=\"pill\"><div class=\"pic\"><img decoding=\"async\" loading=\"lazy\" class=\"ph-img\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-quality-audit.jpg\" alt=\"Especialista revisando um documento do sistema da qualidade\"><\/div><div class=\"in\"><p class=\"eye\" style=\"font-size: 12px\">Regulat\u00f3rio e Qualidade<\/p><h3 class=\"h3\">Regulariza\u00e7\u00e3o e um sistema da qualidade que se sustenta na auditoria<\/h3><ul><li><svg width=\"20\" height=\"20\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#2A72C8\" stroke-width=\"2.4\" aria-hidden=\"true\" style=\"flex:0 0 20px;margin-top:2px\"><path d=\"M20 6 9 17l-5-5\"><\/path><\/svg><span>Notifica\u00e7\u00e3o, registro, altera\u00e7\u00f5es e revalida\u00e7\u00f5es na Anvisa, e acesso aos outros quatro mercados<\/span><\/li><li><svg width=\"20\" height=\"20\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#2A72C8\" stroke-width=\"2.4\" aria-hidden=\"true\" style=\"flex:0 0 20px;margin-top:2px\"><path d=\"M20 6 9 17l-5-5\"><\/path><\/svg><span>Sistema da qualidade e risco: BPF (RDC 665\/2022), ISO 13485, MDSAP, ISO 14971<\/span><\/li><li><svg width=\"20\" height=\"20\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#2A72C8\" stroke-width=\"2.4\" aria-hidden=\"true\" style=\"flex:0 0 20px;margin-top:2px\"><path d=\"M20 6 9 17l-5-5\"><\/path><\/svg><span>Auditorias internas, de fornecedores e simuladas para a inspe\u00e7\u00e3o de BPF<\/span><\/li><li><svg width=\"20\" height=\"20\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#2A72C8\" stroke-width=\"2.4\" aria-hidden=\"true\" style=\"flex:0 0 20px;margin-top:2px\"><path d=\"M20 6 9 17l-5-5\"><\/path><\/svg><span>Transfer\u00eancia de titularidade na Anvisa, com o dossi\u00ea conferido antes<\/span><\/li><\/ul><div class=\"foot\"><span class=\"go\">Ver Regulat\u00f3rio e Qualidade <span>\u2192<\/span><\/span><\/div><\/div><\/a>\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/evidencia-clinica-seguranca-produto\/\" class=\"pill\"><div class=\"pic\"><img decoding=\"async\" loading=\"lazy\" class=\"ph-img\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-biological-evaluation-device-report.jpg\" alt=\"Duas especialistas revisando um relat\u00f3rio de avalia\u00e7\u00e3o biol\u00f3gica\"><\/div><div class=\"in\"><p class=\"eye\" style=\"font-size: 12px\">Evid\u00eancia Cl\u00ednica e Seguran\u00e7a do Produto<\/p><h3 class=\"h3\">Evid\u00eancia de seguran\u00e7a planejada uma vez e adaptada a cada mercado<\/h3><ul><li><svg width=\"20\" height=\"20\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#2A72C8\" stroke-width=\"2.4\" aria-hidden=\"true\" style=\"flex:0 0 20px;margin-top:2px\"><path d=\"M20 6 9 17l-5-5\"><\/path><\/svg><span>Biocompatibilidade: an\u00e1lise de lacunas, plano de avalia\u00e7\u00e3o biol\u00f3gica, ISO 10993<\/span><\/li><li><svg width=\"20\" height=\"20\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#2A72C8\" stroke-width=\"2.4\" aria-hidden=\"true\" style=\"flex:0 0 20px;margin-top:2px\"><path d=\"M20 6 9 17l-5-5\"><\/path><\/svg><span>Caracteriza\u00e7\u00e3o qu\u00edmica e avalia\u00e7\u00e3o de risco toxicol\u00f3gico<\/span><\/li><li><svg width=\"20\" height=\"20\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#2A72C8\" stroke-width=\"2.4\" aria-hidden=\"true\" style=\"flex:0 0 20px;margin-top:2px\"><path d=\"M20 6 9 17l-5-5\"><\/path><\/svg><span>Avalia\u00e7\u00e3o cl\u00ednica para cada mercado<\/span><\/li><li><svg width=\"20\" height=\"20\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#2A72C8\" stroke-width=\"2.4\" aria-hidden=\"true\" style=\"flex:0 0 20px;margin-top:2px\"><path d=\"M20 6 9 17l-5-5\"><\/path><\/svg><span>Revis\u00e3o documental: o que seus documentos comprovam e o que falta<\/span><\/li><\/ul><div class=\"foot\"><span class=\"go\">Ver Evid\u00eancia Cl\u00ednica e Seguran\u00e7a <span>\u2192<\/span><\/span><\/div><\/div><\/a>\n<\/div>\n<div style=\"margin-top: 20px; display: flex; gap: 14px; align-items: center; background: #FDF6E3; border-radius: 16px; padding: 18px 22px; font-size: 16px; line-height: 1.5; color: #3A2B00\"><svg width=\"20\" height=\"20\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#B8860B\" stroke-width=\"2.2\" aria-hidden=\"true\" style=\"flex:0 0 20px;margin-top:2px\"><path d=\"M21 12a9 9 0 1 1-3-6.7\"><\/path><path d=\"M21 4v5h-5\"><\/path><\/svg><span><b>Suporte cont\u00ednuo das duas equipes:<\/b> um escopo mensal para altera\u00e7\u00f5es, revalida\u00e7\u00f5es, tecnovigil\u00e2ncia e atualiza\u00e7\u00f5es de seguran\u00e7a, montado para o seu portf\u00f3lio.<\/span><a href=\"https:\/\/sobelconsult.com\/pt-br\/como-trabalhamos\/#shw-ongoing\" class=\"arrow\" style=\"margin-left: auto; white-space: nowrap\">Como funciona \u2192<\/a><\/div>\n<\/div>\n<\/section>\n<!-- 6 \u00b7 WHERE ARE YOU TODAY (situations) -->\n<section class=\"sec\" style=\"background: #FFFFFF\">\n<div class=\"wrap\">\n<div class=\"hd\"><p class=\"eye\">Onde voc\u00ea est\u00e1 hoje?<\/p><h2 class=\"h2\" style=\"margin-top: 0\">Comece pela sua <span class=\"gold\">situa\u00e7\u00e3o<\/span><\/h2><\/div>\n<div class=\"g3\" style=\"margin-top: 40px\">\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/produto-travado-na-anvisa\/\" class=\"sit\"><div class=\"pic\"><img decoding=\"async\" loading=\"lazy\" class=\"ph-img\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-anvisa-indeferimento-oficio-carimbo.webp\" alt=\"Of\u00edcio da Anvisa com carimbo sobre a mesa\"><\/div><div class=\"in\"><span class=\"chip\" style=\"align-self: flex-start; background: #FBE7E4; color: #9A2B1E\">Exig\u00eancia ou indeferimento<\/span><h3 style=\"margin: 0; font: 700 20px\/1.3 Lora, Georgia, serif; color: #051B5A\">Produto parado na Anvisa<\/h3><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #2B2E34\">Uma exig\u00eancia t\u00e9cnica, um indeferimento ou um processo que n\u00e3o anda. Lemos o of\u00edcio e planejamos a resposta dentro do prazo.<\/p><span class=\"arrow\" style=\"align-self: flex-start; margin-top: auto\">O que fazer agora \u2192<\/span><\/div><\/a>\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/regulatorio-qualidade\/\" class=\"sit\"><div class=\"pic\"><img decoding=\"async\" loading=\"lazy\" class=\"ph-img\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/Brazilian-Registration-Holder-ANVISA.webp\" alt=\"Reuni\u00e3o sobre a transfer\u00eancia de um registro\"><\/div><div class=\"in\"><span class=\"chip\" style=\"align-self: flex-start; background: #E4F2E8; color: #1E6B3A\">Mudan\u00e7a de detentor<\/span><h3 style=\"margin: 0; font: 700 20px\/1.3 Lora, Georgia, serif; color: #051B5A\">Transfer\u00eancia de titularidade<\/h3><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #2B2E34\">Vai assumir ou repassar um registro? Conferimos o dossi\u00ea antes do pedido, para a transfer\u00eancia n\u00e3o travar na Anvisa.<\/p><span class=\"arrow\" style=\"align-self: flex-start; margin-top: auto\">Ver como funciona \u2192<\/span><\/div><\/a>\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/materiais\/guia-iso-10993-1-2025-anvisa\/\" class=\"sit\"><div class=\"pic\"><img decoding=\"async\" loading=\"lazy\" class=\"ph-img\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-md_card_dental-implant_gloved-hand.webp\" alt=\"M\u00e3o com luva segurando um implante dent\u00e1rio\"><\/div><div class=\"in\"><span class=\"chip\" style=\"align-self: flex-start; background: #FDF0CE; color: #7A5B00\">E-book gratuito<\/span><h3 style=\"margin: 0; font: 700 20px\/1.3 Lora, Georgia, serif; color: #051B5A\">ISO 10993-1:2025: o que muda<\/h3><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #2B2E34\">As principais mudan\u00e7as da nova norma de avalia\u00e7\u00e3o biol\u00f3gica, agora ABNT NBR, e um plano passo a passo.<\/p><span class=\"arrow\" style=\"align-self: flex-start; margin-top: auto\">Baixar o guia \u2192<\/span><\/div><\/a>\n<\/div>\n<\/div>\n<\/section>\n<!-- 9 \u00b7 WHY SOBEL \u00b7 page version with testimonials -->\n<section class=\"sec\" style=\"background: #051B5A; color: #FFFFFF\">\n<div class=\"wrap\">\n<div class=\"whyg\">\n<div style=\"display: flex; flex-direction: column; gap: 22px\">\n<p class=\"eye lt\">Por que a Sobel<\/p>\n<h2 class=\"h2\" style=\"color: #FFFFFF; margin-top: 0\">\u201cSabemos como um auditor pensa, porque j\u00e1 fomos <span class=\"gold\">um deles<\/span>.\u201d<\/h2>\n<div style=\"display: flex; gap: 14px; align-items: center\"><img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait.webp\" alt=\"Maik Endler\" style=\"width: 56px; height: 56px; border-radius: 50%; object-fit: cover; border: 2px solid #F2B705\"><div style=\"font-size: 15px; line-height: 1.45; color: #DCE4FF\"><b style=\"color: #FFFFFF\">Maik Endler<\/b> \u00b7 Fundador e CEO<br>Engenheiro mec\u00e2nico formado na Alemanha, ex-auditor do BSI (Organismo Notificado)<\/div><\/div>\n<\/div>\n<div class=\"tcard\" aria-roledescription=\"carousel\" aria-label=\"Depoimentos de clientes\"><div class=\"tslide\" data-ti=\"0\"><div style=\"display: flex; gap: 16px; align-items: center\"><img loading=\"lazy\" decoding=\"async\" loading=\"lazy\" loading=\"lazy\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/06\/andreas-andratec-sobel-1-300x300.webp\" alt=\"Andreas Kohl\" width=\"64\" height=\"64\" style=\"width: 64px; height: 64px; border-radius: 50%; object-fit: cover\"><div><p style=\"margin: 0; font-weight: 700; color: #051B5A\">Andreas Kohl<\/p><p style=\"margin: 2px 0 0; font-size: 14px; color: #4F535B\">CEO \u00b7 Andratec (Alemanha)<\/p><\/div><\/div>\n<p style=\"margin: 0; font: 700 20px\/1.3 Lora, Georgia, serif; color: #051B5A\">Solu\u00e7\u00f5es r\u00e1pidas, focadas nos seus objetivos<\/p>\n<p style=\"margin: 0; font-size: 17px; line-height: 1.6; color: #2B2E34\">\u201cA Sobel prestou um atendimento cordial e focado em objetivos, com solu\u00e7\u00f5es r\u00e1pidas. Esperamos trabalhar juntos em novos projetos. (tradu\u00e7\u00e3o livre)\u201d<\/p><\/div>\n<div class=\"tslide\" data-ti=\"1\" hidden><div style=\"display: flex; gap: 16px; align-items: center\"><img loading=\"lazy\" decoding=\"async\" loading=\"lazy\" loading=\"lazy\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/08\/Mandy-Blocher.jpeg\" alt=\"Mandy Blocher\" width=\"64\" height=\"64\" style=\"width: 64px; height: 64px; border-radius: 50%; object-fit: cover\"><div><p style=\"margin: 0; font-weight: 700; color: #051B5A\">Mandy Blocher<\/p><p style=\"margin: 2px 0 0; font-size: 14px; color: #4F535B\">Expert Regulatory Framework &amp; Digital Transformation \u00b7 Aesculap AG (B. Braun)<\/p><\/div><\/div>\n<p style=\"margin: 0; font: 700 20px\/1.3 Lora, Georgia, serif; color: #051B5A\">Conhecimento amplo, colabora\u00e7\u00e3o de verdade<\/p>\n<p style=\"margin: 0; font-size: 17px; line-height: 1.6; color: #2B2E34\">\u201cSempre tive da Sobel Consult uma colabora\u00e7\u00e3o prestativa e proativa, com alto grau de compet\u00eancia em um amplo leque regulat\u00f3rio. (tradu\u00e7\u00e3o livre)\u201d<\/p><\/div>\n<div style=\"display: flex; align-items: center; justify-content: space-between; margin-top: auto\"><div style=\"display: flex; gap: 8px\"><button type=\"button\" class=\"dot on\" data-go=\"0\" aria-label=\"Depoimento 1\" style=\"border:0;padding:0\"><\/button><button type=\"button\" class=\"dot\" data-go=\"1\" aria-label=\"Depoimento 2\" style=\"border:0;padding:0\"><\/button><\/div><div style=\"display: flex; gap: 8px\"><button type=\"button\" class=\"tbtn\" data-step=\"-1\" aria-label=\"Anterior\">\u2190<\/button><button type=\"button\" class=\"tbtn\" data-step=\"1\" aria-label=\"Pr\u00f3ximo\">\u2192<\/button><\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n\n<!-- 8 \u00b7 FAQ -->\n<section class=\"sec\" style=\"background: #FFFFFF\">\n<div class=\"wrap\">\n<div class=\"g-faq\">\n<div style=\"display: flex; flex-direction: column\"><p class=\"eye\">Perguntas frequentes<\/p><h2 class=\"h2\" style=\"margin-top: 20px\">D\u00favidas sobre a <span class=\"gold\">regulariza\u00e7\u00e3o<\/span> de dispositivos m\u00e9dicos<\/h2><a href=\"#footer-cta\" class=\"btn-line\" style=\"align-self: flex-start; margin-top: 32px\">Enviar minha pergunta \u2192<\/a><\/div>\n<div style=\"display: flex; flex-direction: column; gap: 12px\">\n<details class=\"q\" open><summary><span>Qual a diferen\u00e7a entre notifica\u00e7\u00e3o e registro na Anvisa?<\/span><span class=\"plus\" aria-hidden=\"true\">+<\/span><\/summary><p>Depende da classe de risco (RDC 751\/2022). Classes I e II seguem a notifica\u00e7\u00e3o, um processo mais simples. Classes III e IV precisam de registro, com an\u00e1lise t\u00e9cnica do dossi\u00ea e Certificado de Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o.<\/p><\/details>\n<details class=\"q\"><summary><span>Preciso do Certificado de Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o?<\/span><span class=\"plus\" aria-hidden=\"true\">+<\/span><\/summary><p>Para classes III e IV, sim: a Anvisa exige o certificado (RDC 665\/2022), inclusive para fabricantes no exterior. Para classes I e II, as Boas Pr\u00e1ticas valem do mesmo jeito, mas sem certifica\u00e7\u00e3o pr\u00e9via.<\/p><\/details>\n<details class=\"q\"><summary><span>Quanto tempo leva o registro na Anvisa?<\/span><span class=\"plus\" aria-hidden=\"true\">+<\/span><\/summary><p>Depende da classe e da fila de cada \u00e1rea. Dados da pr\u00f3pria Anvisa de 2024 mostram de 9 a 12 meses de espera para an\u00e1lise de materiais. O seu plano mostra o prazo de cada etapa antes de come\u00e7ar.<\/p><\/details>\n<details class=\"q\"><summary><span>Recebi uma exig\u00eancia da Anvisa. O que eu fa\u00e7o?<\/span><span class=\"plus\" aria-hidden=\"true\">+<\/span><\/summary><p>N\u00e3o deixe o prazo correr: exig\u00eancia sem resposta vira indeferimento. Lemos o of\u00edcio, separamos o que \u00e9 t\u00e9cnico do que \u00e9 documental e montamos a resposta com voc\u00ea.<\/p><\/details>\n<details class=\"q\"><summary><span>O registro na Anvisa serve para exportar?<\/span><span class=\"plus\" aria-hidden=\"true\">+<\/span><\/summary><p>N\u00e3o diretamente, mas o seu dossi\u00ea \u00e9 a base. Sistema da qualidade, gerenciamento de risco, avalia\u00e7\u00e3o biol\u00f3gica e ensaios s\u00e3o reaproveitados; cada mercado acrescenta a sua classifica\u00e7\u00e3o, os seus formul\u00e1rios e um representante local. A Sobel atua como Representante Autorizada na Europa e US Agent nos Estados Unidos com empresas pr\u00f3prias.<\/p><\/details>\n<details class=\"q\"><summary><span>Voc\u00eas tamb\u00e9m atendem IVD?<\/span><span class=\"plus\" aria-hidden=\"true\">+<\/span><\/summary><p>Sim, no Brasil. Veja a nossa <a href=\"https:\/\/sobelconsult.com\/pt-br\/registro-ivd-anvisa\/\" style=\"color: #051B5A; font-weight: 600; text-decoration: underline\">p\u00e1gina de IVD<\/a> para regulariza\u00e7\u00e3o de reagentes, analisadores e testes na Anvisa.<\/p><\/details>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<!-- 9 \u00b7 RELATED ARTICLES -->\n<section class=\"sec\">\n<div class=\"wrap\">\n<div class=\"hd c\"><p class=\"eye\">Continue lendo<\/p><h2 class=\"h2\" style=\"margin-top: 0\">Novidades em <span class=\"gold\">dispositivos m\u00e9dicos<\/span><\/h2><\/div>\n<div class=\"g3\" style=\"margin-top: 40px\">\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/prazo-para-registro-no-eudamed-novembro-de-2026-informacao-novembro-de-2026\/\" class=\"card\" style=\"display: flex; flex-direction: column; overflow: hidden; text-decoration: none; border-top: 4px solid #2A72C8\"><div style=\"height: 200px; overflow: hidden\"><img decoding=\"async\" loading=\"lazy\" class=\"ph-img\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/09\/eudamed-deadline-2026-registration-768x432.webp\" alt=\"Prazo de registro no EUDAMED em 2026\"><\/div><div style=\"padding: 20px 22px 24px; display: flex; flex-direction: column; gap: 10px\"><span class=\"chip\" style=\"align-self: flex-start; background: #E3EEFB; color: #174A8C\">Dispositivos m\u00e9dicos<\/span><h3 style=\"margin: 0; font: 700 19px\/1.3 Lora, Georgia, serif; color: #051B5A\">Prazo do EUDAMED 2026: o que fazer antes de 27 de novembro<\/h3><span style=\"font-size: 14px; color: #4F535B\">28\/09\/2026<\/span><\/div><\/a>\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/abnt-nbr-iso-10993-1-anvisa-informacao\/\" class=\"card\" style=\"display: flex; flex-direction: column; overflow: hidden; text-decoration: none; border-top: 4px solid #2A72C8\"><div style=\"height: 200px; overflow: hidden\"><img decoding=\"async\" loading=\"lazy\" class=\"ph-img\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/Biological-Evaluation-ISO-10993-1-1-768x432.jpg\" alt=\"Avalia\u00e7\u00e3o biol\u00f3gica pela ISO 10993-1\"><\/div><div style=\"padding: 20px 22px 24px; display: flex; flex-direction: column; gap: 10px\"><span class=\"chip\" style=\"align-self: flex-start; background: #E3EEFB; color: #174A8C\">Dispositivos m\u00e9dicos<\/span><h3 style=\"margin: 0; font: 700 19px\/1.3 Lora, Georgia, serif; color: #051B5A\">ISO 10993-1:2025 agora \u00e9 ABNT NBR: o que muda na Anvisa<\/h3><span style=\"font-size: 14px; color: #4F535B\">14\/10\/2026<\/span><\/div><\/a>\n<a href=\"https:\/\/sobelconsult.com\/pt-br\/falhas-dossie-anvisa\/\" class=\"card\" style=\"display: flex; flex-direction: column; overflow: hidden; text-decoration: none; border-top: 4px solid #2A72C8\"><div style=\"height: 200px; overflow: hidden\"><img decoding=\"async\" loading=\"lazy\" class=\"ph-img\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/MDR-IVDR-documents-768x512.jpg\" alt=\"Documentos regulat\u00f3rios sobre a mesa\"><\/div><div style=\"padding: 20px 22px 24px; display: flex; flex-direction: column; gap: 10px\"><span class=\"chip\" style=\"align-self: flex-start; background: #E3EEFB; color: #174A8C\">Dispositivos m\u00e9dicos<\/span><h3 style=\"margin: 0; font: 700 19px\/1.3 Lora, Georgia, serif; color: #051B5A\">Os erros de dossi\u00ea que mais travam pedidos na Anvisa<\/h3><span style=\"font-size: 14px; color: #4F535B\">24\/10\/2026<\/span><\/div><\/a>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\n<script>\n(function(){var r=document.querySelector('.sbc');if(!r)return;\nvar tabs=[].slice.call(r.querySelectorAll('button.mkbtn[data-mk]')),pan=[].slice.call(r.querySelectorAll('.mkpanel[data-panel]'));\nfunction pick(k){tabs.forEach(function(t){var on=t.getAttribute('data-mk')===k;t.classList.toggle('on',on);t.setAttribute('aria-selected',on?'true':'false')});pan.forEach(function(p){p.hidden=p.getAttribute('data-panel')!==k})}\ntabs.forEach(function(t){t.addEventListener('click',function(){pick(t.getAttribute('data-mk'))})});\n[].forEach.call(r.querySelectorAll('a.mkbtn[data-mk]'),function(a){a.addEventListener('click',function(){pick(a.getAttribute('data-mk'))})});\nvar sl=[].slice.call(r.querySelectorAll('.tslide')),dots=[].slice.call(r.querySelectorAll('.dot[data-go]')),ti=0;\nfunction show(i){ti=(i+sl.length)%sl.length;sl.forEach(function(s,j){s.hidden=j!==ti});dots.forEach(function(d,j){d.classList.toggle('on',j===ti)})}\ndots.forEach(function(d){d.addEventListener('click',function(){show(+d.getAttribute('data-go'))})});\n[].forEach.call(r.querySelectorAll('.tbtn[data-step]'),function(b){b.addEventListener('click',function(){show(ti+(+b.getAttribute('data-step')))})});\n})();\n<\/script>\n<script type=\"application\/ld+json\">{\"@context\": \"https:\/\/schema.org\", \"@graph\": [{\"@type\": \"Service\", \"name\": \"Consultoria regulat\u00f3ria para dispositivos m\u00e9dicos\", \"serviceType\": \"Consultoria regulat\u00f3ria para dispositivos m\u00e9dicos\", \"inLanguage\": \"pt-BR\", \"provider\": {\"@type\": \"Organization\", \"name\": \"Sobel\", \"url\": \"https:\/\/sobelconsult.com\/pt-br\/\"}, \"areaServed\": [{\"@type\": \"Country\", \"name\": \"Brasil\"}, {\"@type\": \"Place\", \"name\": \"Uni\u00e3o Europeia\"}, {\"@type\": \"Country\", \"name\": \"Reino Unido\"}, {\"@type\": \"Country\", \"name\": \"Estados Unidos\"}, {\"@type\": \"Country\", \"name\": \"Canad\u00e1\"}], \"url\": \"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/dispositivos-medicos\/\", \"description\": \"Notifica\u00e7\u00e3o e registro de dispositivos m\u00e9dicos na Anvisa, Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o e exporta\u00e7\u00e3o para Europa (MDR), Reino Unido (MHRA), Estados Unidos (FDA) e Canad\u00e1 (Health Canada).\"}, {\"@type\": \"FAQPage\", \"inLanguage\": \"pt-BR\", \"mainEntity\": [{\"@type\": \"Question\", \"name\": \"Qual a diferen\u00e7a entre notifica\u00e7\u00e3o e registro na Anvisa?\", \"acceptedAnswer\": {\"@type\": \"Answer\", \"text\": \"Depende da classe de risco (RDC 751\/2022). 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