{"id":1981,"date":"2021-02-06T21:48:44","date_gmt":"2021-02-07T00:48:44","guid":{"rendered":"https:\/\/mastersul.com.br\/fique-por-dentro-da-nova-resolucao-da-anvisa\/"},"modified":"2022-11-10T11:04:57","modified_gmt":"2022-11-10T14:04:57","slug":"fique-por-dentro-da-nova-resolucao-da-anvisa","status":"publish","type":"post","link":"https:\/\/mastersul.com.br\/en\/fique-por-dentro-da-nova-resolucao-da-anvisa\/","title":{"rendered":"Fique por dentro da nova resolu\u00e7\u00e3o da Anvisa"},"content":{"rendered":"\r\n<p>Aten\u00e7\u00e3o para as <strong>novas regras<\/strong> na importa\u00e7\u00e3o de itens da \u00e1rea da sa\u00fade. No dia 30\/04, a Anvisa publicou a resolu\u00e7\u00e3o RDC N\u00ba 379\/2020 (de car\u00e1ter extraordin\u00e1rio e tempor\u00e1rio) para definir alguns pontos a respeito da aquisi\u00e7\u00e3o e importa\u00e7\u00e3o de dispositivos m\u00e9dicos.<\/p>\r\n\r\n\r\n\r\n<p>Separamos os tr\u00eas principais destaques desta altera\u00e7\u00e3o. Confira:<\/p>\r\n\r\n\r\n\r\n<h3 class=\"wp-block-heading\">Principais altera\u00e7\u00f5es da RDN n\u00b0 379\/2020<\/h3>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>Autoriza\u00e7\u00e3o de funcionamento (AFE) dispensada temporariamente. Isso significa que os produtos ter\u00e3o o deferimento autom\u00e1tico do licenciamento de importa\u00e7\u00e3o. A partir de agora, \u00e9 dever do importador garantir a proced\u00eancia, qualidade e seguran\u00e7a dos produtos;<\/li>\r\n<li>Autoriza\u00e7\u00e3o da importa\u00e7\u00e3o de alguns produtos novos e que ainda n\u00e3o s\u00e3o homologados pela Anvisa, desde que regularizados e comercializados em jurisdi\u00e7\u00e3o do IMDRF. Para esses casos, \u00e9 necess\u00e1rio que o importador tenha AFE;<\/li>\r\n<li>Na importa\u00e7\u00e3o de kits para diagn\u00f3stico de covid-19, os itens devem ser enviados para a an\u00e1lise do Instituto Nacional de Controle de Qualidade (INCQS) no prazo m\u00e1ximo de 5 dias, contados da data do desembara\u00e7o da carga;<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>Para conferir a resolu\u00e7\u00e3o na \u00edntegra, <a href=\"http:\/\/www.in.gov.br\/en\/web\/dou\/-\/resolucao-rdc-n-379-de-30-de-abril-de-2020-254764712\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (abre numa nova aba)\"><strong>clique aqui.<\/strong><\/a><\/p>\r\n\r\n\r\n\r\n<h3 class=\"wp-block-heading\">Fique atento!<\/h3>\r\n\r\n\r\n\r\n<p>Observar os detalhes e cumprir todos as disposi\u00e7\u00f5es legais \u00e9 fundamental para evitar erros nos processos de importa\u00e7\u00e3o. Al\u00e9m disso, manter-se informado \u00e9 essencial neste momento. Fique por aqui e confira todas as atualiza\u00e7\u00f5es:<\/p>\r\n\r\n\r\n\r\n<p>Aduanas do Brasil: confira como est\u00e1 a situa\u00e7\u00e3o em tempos de Coronav\u00edrus \u2013\u00a0<a href=\"https:\/\/mastersul.com.br\/blog\/aduanas-do-brasil-confira-como-esta-a-situacao-em-tempos-de-coronavirus\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (abre numa nova aba)\"><strong>clique aqui<\/strong><\/a><\/p>\r\n\r\n\r\n\r\n<p>Saiba quais s\u00e3o as medidas econ\u00f4micas para enfrentar a crise do Coronav\u00edrus no Brasil \u2013\u00a0<strong><a href=\"https:\/\/mastersul.com.br\/blog\/saiba-quais-sao-as-medidas-economicas-para-enfrentar-a-crise-do-coronavirus-no-brasil\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (abre numa nova aba)\">clique aqui<\/a><\/strong><\/p>\r\n\r\n\r\n\r\n<p>Saiba os impactos do coronav\u00edrus no Com\u00e9rcio Exterior \u2013\u00a0<strong><a href=\"https:\/\/mastersul.com.br\/blog\/impactos-do-coronavirus-no-comercio-exterior\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (abre numa nova aba)\">clique aqui<\/a><\/strong><\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>Aten\u00e7\u00e3o para as novas regras na importa\u00e7\u00e3o de itens da \u00e1rea da sa\u00fade. No dia 30\/04, a Anvisa publicou a resolu\u00e7\u00e3o RDC N\u00ba 379\/2020 (de car\u00e1ter extraordin\u00e1rio e tempor\u00e1rio) para definir alguns pontos a respeito da aquisi\u00e7\u00e3o e importa\u00e7\u00e3o de dispositivos m\u00e9dicos. Separamos os tr\u00eas principais destaques desta altera\u00e7\u00e3o. Confira: Principais altera\u00e7\u00f5es da RDN n\u00b0 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1982,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[1],"tags":[],"class_list":["post-1981","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sem-categoria"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Fique por dentro da nova resolu\u00e7\u00e3o da Anvisa<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mastersul.com.br\/en\/fique-por-dentro-da-nova-resolucao-da-anvisa\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:locale:alternate\" content=\"pt_BR\" \/>\n<meta property=\"og:locale:alternate\" content=\"es\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Fique por dentro da nova resolu\u00e7\u00e3o da Anvisa\" \/>\n<meta property=\"og:description\" content=\"Aten\u00e7\u00e3o para as novas regras na importa\u00e7\u00e3o de itens da \u00e1rea da sa\u00fade. No dia 30\/04, a Anvisa publicou a resolu\u00e7\u00e3o RDC N\u00ba 379\/2020 (de car\u00e1ter extraordin\u00e1rio e tempor\u00e1rio) para definir alguns pontos a respeito da aquisi\u00e7\u00e3o e importa\u00e7\u00e3o de dispositivos m\u00e9dicos. Separamos os tr\u00eas principais destaques desta altera\u00e7\u00e3o. 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