{"id":5242,"date":"2020-10-22T12:44:49","date_gmt":"2020-10-22T12:44:49","guid":{"rendered":"http:\/\/ztecmedical.com\/?p=5242"},"modified":"2020-12-16T21:31:55","modified_gmt":"2020-12-16T21:31:55","slug":"brazil","status":"publish","type":"post","link":"https:\/\/ztecmedical.com\/pt\/brazil\/","title":{"rendered":"Exportando Para o Brasil"},"content":{"rendered":"<section class=\"l-section wpb_row height_medium\"><div class=\"l-section-h i-cf\"><div class=\"g-cols offset_small\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"w-video ratio_16x9\"><div class=\"w-video-h\"><iframe width=\"1500\" height=\"844\" src=\"https:\/\/www.youtube.com\/embed\/RTDfzViARYE?wmode=transparent&amp;rel=0&amp;feature=oembed\" frameborder=\"0\" allowfullscreen><\/iframe><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row height_medium\"><div class=\"l-section-h i-cf\"><div class=\"g-cols offset_small\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column \"><div class=\"wpb_wrapper\"><p>Os dispositivos m\u00e9dicos vendidos no Brasil devem se registrar na ANVISA, respons\u00e1vel por todas as fun\u00e7\u00f5es de registro e inspe\u00e7\u00e3o dentro da ag\u00eancia.<\/p>\n<p>Com a crescente popula\u00e7\u00e3o atingindo 210 milh\u00f5es, o Brasil representa o maior mercado da Am\u00e9rica do Sul para dispositivos m\u00e9dicos, servi\u00e7os de sa\u00fade e tamb\u00e9m um dos maiores do mundo.<\/p>\n<p>Dentro das 10 principais economias do mundo, o Brasil tem um programa de regulamenta\u00e7\u00f5es maduro em vigor. O Brasil \u00e9 membro do Mercado Comum do Sul, tamb\u00e9m conhecido como MERCOSUL, que parcialmente regulariza as regulamenta\u00e7\u00f5es com a Argentina, Paraguai e Uruguai. Todos os dispositivos m\u00e9dicos vendidos no Brasil devem se registrar na Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (ANVISA), que \u00e9 essencialmente uma ag\u00eancia reguladora independente e administrada de forma independente, respons\u00e1vel pela regulamenta\u00e7\u00e3o e supervis\u00e3o de todos os dispositivos m\u00e9dicos. A ANVISA mant\u00e9m o banco de dados de produtos registrados e executa todas as fun\u00e7\u00f5es de registro e inspe\u00e7\u00e3o dentro da ag\u00eancia.<\/p>\n<p>As empresas precisam se basear no Brasil para se registrar na ANVISA, de modo que as empresas que exportam para o Brasil devem operar com uma entidade no pa\u00eds, por exemplo, distribuidora ou concession\u00e1ria.<\/p>\n<p>A classifica\u00e7\u00e3o de dispositivos no Brasil baseia-se em risco semelhante ao aplicado na Uni\u00e3o Europeia. Os dispositivos de Classe I e II possuem um processo de aplica\u00e7\u00e3o relativamente f\u00e1cil, que \u00e0s vezes varia dependendo do uso do dispositivo.<\/p>\n<p>Podem ser necess\u00e1rios dispositivos de alto risco para fornecer toda ou parte da seguinte documenta\u00e7\u00e3o com sua aplica\u00e7\u00e3o:<\/p>\n<p>Certificado de venda gratuita (pode ser substitu\u00eddo pelo certificado INMETRO quando aplic\u00e1vel) ou certificado de boas pr\u00e1ticas de fabrica\u00e7\u00e3o (GMP) ou manual de instru\u00e7\u00f5es em portugu\u00eas ou rotulagem e embalagem ou carta do fabricante do dispositivo, autorizando uma empresa brasileira a manter o registro do produto e distribuir um dispositivo ou ensaios cl\u00ednicos (ocasionalmente pode ser substitu\u00eddo pela certifica\u00e7\u00e3o INMETRO que comprove a efic\u00e1cia geral do dispositivo.<\/p>\n<p>Al\u00e9m disso, para alguns dispositivos, por exemplo, dispositivos m\u00e9dicos implant\u00e1veis, produtos cardiovasculares, DIVs de alto risco, dispositivos de di\u00e1lise e sistemas de aparelhos auditivos individuais, utilizando relat\u00f3rio de informa\u00e7\u00f5es econ\u00f4micas e certifica\u00e7\u00e3o INMETRO, quando aplic\u00e1vel.<\/p><\/div> <\/div> <\/div><\/div><\/div><\/div><\/section>","protected":false},"excerpt":{"rendered":"Os dispositivos m\u00e9dicos vendidos no Brasil devem se registrar na ANVISA, respons\u00e1vel por todas as fun\u00e7\u00f5es de registro e inspe\u00e7\u00e3o dentro da ag\u00eancia. Com a crescente popula\u00e7\u00e3o atingindo 210 milh\u00f5es,...","protected":false},"author":1,"featured_media":5244,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"video","meta":[],"categories":[36],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v15.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ztecmedical.com\/brazil\/\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"[:en]Exporting to Brazil[:es]Exportando a Brasil[:pt]Exportando Para o Brasil[:] | ZTEC MEDICAL\" \/>\n<meta property=\"og:url\" content=\"https:\/\/ztecmedical.com\/brazil\/\" \/>\n<meta property=\"og:site_name\" content=\"ZTEC MEDICAL\" \/>\n<meta property=\"article:published_time\" content=\"2020-10-22T12:44:49+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-12-16T21:31:55+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/ztecmedical.com\/wp-content\/uploads\/2016\/09\/ztec-at-Brazil-f.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"667\" \/>\n<meta name=\"twitter:card\" content=\"summary\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\">\n\t<meta name=\"twitter:data1\" content=\"5 minutos\">\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebSite\",\"@id\":\"https:\/\/ztecmedical.com\/#website\",\"url\":\"https:\/\/ztecmedical.com\/\",\"name\":\"ZTEC MEDICAL\",\"description\":\"Medical Equipment Export, Medical Devices\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":\"https:\/\/ztecmedical.com\/?s={search_term_string}\",\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"pt-PT\"},{\"@type\":\"ImageObject\",\"@id\":\"https:\/\/ztecmedical.com\/brazil\/#primaryimage\",\"inLanguage\":\"pt-PT\",\"url\":\"https:\/\/ztecmedical.com\/wp-content\/uploads\/2016\/09\/ztec-at-Brazil-f.jpg\",\"width\":1000,\"height\":667,\"caption\":\"ztec-at-brazil\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/ztecmedical.com\/brazil\/#webpage\",\"url\":\"https:\/\/ztecmedical.com\/brazil\/\",\"name\":\"[:en]Exporting to Brazil[:es]Exportando a Brasil[:pt]Exportando Para o Brasil[:] | ZTEC MEDICAL\",\"isPartOf\":{\"@id\":\"https:\/\/ztecmedical.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/ztecmedical.com\/brazil\/#primaryimage\"},\"datePublished\":\"2020-10-22T12:44:49+00:00\",\"dateModified\":\"2020-12-16T21:31:55+00:00\",\"author\":{\"@id\":\"https:\/\/ztecmedical.com\/#\/schema\/person\/4a4be33f33b2c4db46c1757f569c9739\"},\"inLanguage\":\"pt-PT\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/ztecmedical.com\/brazil\/\"]}]},{\"@type\":\"Person\",\"@id\":\"https:\/\/ztecmedical.com\/#\/schema\/person\/4a4be33f33b2c4db46c1757f569c9739\",\"name\":\"admin\",\"image\":{\"@type\":\"ImageObject\",\"@id\":\"https:\/\/ztecmedical.com\/#personlogo\",\"inLanguage\":\"pt-PT\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/e9635536ce2d1bde910308bca7e5a907?s=96&d=mm&r=g\",\"caption\":\"admin\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","_links":{"self":[{"href":"https:\/\/ztecmedical.com\/pt\/wp-json\/wp\/v2\/posts\/5242"}],"collection":[{"href":"https:\/\/ztecmedical.com\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ztecmedical.com\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ztecmedical.com\/pt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ztecmedical.com\/pt\/wp-json\/wp\/v2\/comments?post=5242"}],"version-history":[{"count":3,"href":"https:\/\/ztecmedical.com\/pt\/wp-json\/wp\/v2\/posts\/5242\/revisions"}],"predecessor-version":[{"id":5817,"href":"https:\/\/ztecmedical.com\/pt\/wp-json\/wp\/v2\/posts\/5242\/revisions\/5817"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ztecmedical.com\/pt\/wp-json\/wp\/v2\/media\/5244"}],"wp:attachment":[{"href":"https:\/\/ztecmedical.com\/pt\/wp-json\/wp\/v2\/media?parent=5242"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ztecmedical.com\/pt\/wp-json\/wp\/v2\/categories?post=5242"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ztecmedical.com\/pt\/wp-json\/wp\/v2\/tags?post=5242"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}