{"id":2831,"date":"2018-01-29T13:32:16","date_gmt":"2018-01-29T15:32:16","guid":{"rendered":"http:\/\/passarini.com.br\/trade-fair-medica-2017-2\/"},"modified":"2021-11-17T15:58:53","modified_gmt":"2021-11-17T18:58:53","slug":"brazils-anvisa-streamlines-medical-device-importation-processes","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/brazils-anvisa-streamlines-medical-device-importation-processes\/","title":{"rendered":"Brazil\u2019s ANVISA Streamlines Medical Device Importation Processes"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 hundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-background-position:left center;--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-bg-size:cover;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-slider-sc fusion-flexslider-loading flexslider flexslider-hover-type-none\" data-slideshow_autoplay=\"1\" data-slideshow_smooth_height=\"0\" data-slideshow_speed=\"7000\" style=\"max-width:100%;height:100%;\"><ul class=\"slides\"><li class=\"image\"><span class=\"fusion-image-hover-element hover-type-none\"><img decoding=\"async\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3.webp\" alt=\"newsletter passarini\" width=\"1920\" height=\"500\" class=\"wp-image-7421\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-200x52.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-300x78.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-400x104.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-600x156.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-768x200.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-800x208.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1024x267.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1200x313.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1536x400.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3.webp 1920w\" sizes=\"(max-width: 800px) 100vw, 1200px\" \/><\/span><\/li><\/ul><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:10px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-three-fourth fusion-column-first\" style=\"--awb-bg-size:cover;width:75%;width:calc(75% - ( ( 4% ) * 0.75 ) );margin-right: 4%;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><h2><strong>Brazil\u2019s ANVISA Streamlines Medical Device Importation Processes<\/strong><\/h2>\n<p>A new <a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/anvisa-registrationrecord\">ANVISA<\/a> resolution has simplified medical device importation requirements for Brazil.<br \/>\nImported devices no longer have to undergo inspections at Brazilian points of entry.<br \/>\nAdditional changes to simplify ANVISA importation requirements are anticipated in the near future.<\/p>\n<p>Among other changes, <a href=\"https:\/\/passarini.com.br\/en\/brazil\/anvisa-license\/\">ANVISA<\/a> Resolution RDC 208\/2018 (<a href=\"http:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/RDC_208_2018_.pdf\">link in Portuguese<\/a>) removes requirements that devices imported into Brazil must undergo inspection at sites where they receive product clearance, which should result in faster time to market for affected importers.<\/p>\n<p>RDC 208\/2018: Impact on medical device importers<br \/>\nOther important changes in the new resolution include:<\/p>\n<p>Changing deadlines for responses to importation queries to 30 days<br \/>\nLabeling requirements that now differentiate information according to product class<br \/>\nDevice imports no longer require authentication and signature recognition following implementation of electronic signing and petitioning processes<br \/>\nImporters must no longer link MERCOSUR Common Nomenclature (NCM) to particular procedures.<\/p>\n<h3><strong>Passarini Regulatory Affairs<\/strong><\/h3>\n<\/div><div class=\"fusion-social-links fusion-social-links-1\" style=\"--awb-margin-top:0px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;--awb-box-border-top:0px;--awb-box-border-right:0px;--awb-box-border-bottom:0px;--awb-box-border-left:0px;--awb-icon-colors-hover:rgba(51,51,51,0.8);--awb-box-colors-hover:rgba(255,255,255,0.8);--awb-box-border-color:var(--awb-color3);--awb-box-border-color-hover:var(--awb-color4);\"><div class=\"fusion-social-networks boxed-icons color-type-brand\"><div class=\"fusion-social-networks-wrapper\"><a class=\"fusion-social-network-icon fusion-tooltip fusion-facebook fa-facebook-square fab\" style=\"color:#ffffff;font-size:16px;width:16px;background-color:#3b5998;border-color:#3b5998;border-radius:4px;\" data-placement=\"top\" data-title=\"Facebook\" data-toggle=\"tooltip\" title=\"Facebook\" aria-label=\"facebook\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/www.facebook.com\/passarinigroupoficial\/\"><\/a><a class=\"fusion-social-network-icon fusion-tooltip fusion-linkedin fa-linkedin fab\" style=\"color:#ffffff;font-size:16px;width:16px;background-color:#0077b5;border-color:#0077b5;border-radius:4px;\" data-placement=\"top\" data-title=\"LinkedIn\" data-toggle=\"tooltip\" title=\"LinkedIn\" aria-label=\"linkedin\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/www.linkedin.com\/company-beta\/15249908\"><\/a><\/div><\/div><\/div><div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons has-taglines layout-floated layout-medium-floated layout-small-floated\" style=\"background-color:#f6f6f6;--awb-layout:row;--awb-alignment-small:space-between;\" data-title=\"Passarini Regulatory Affairs\" data-description=\"Brazil\u2019s ANVISA Streamlines Medical Device Importation Processes\r\nA new ANVISA resolution has simplified medical device importation requirements for Brazil.\r\nImported devices no longer have to undergo inspections at Brazilian points of entry.\r\nAdditional changes to simplify ANVISA importation requirements are anticipated in the near future.\r\n\r\nAmong other changes, ANVISA Resolution RDC 208\/2018 (\" data-link=\"http:\/\/passarini.com.br\/en\/brazils-anvisa-streamlines-medical-device-importation-processes\/\"><h4 class=\"tagline\" style=\"color:#000000;\">To share<\/h4><div class=\"fusion-social-networks sharingbox-shortcode-icon-wrapper sharingbox-shortcode-icon-wrapper-1 boxed-icons\"><span><a 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class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":2826,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67,68],"tags":[70,193],"class_list":["post-2831","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa-en","category-brazil","tag-brazil","tag-rdc-en"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/2831","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/comments?post=2831"}],"version-history":[{"count":11,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/2831\/revisions"}],"predecessor-version":[{"id":7514,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/2831\/revisions\/7514"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/2826"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=2831"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=2831"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=2831"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}