{"id":12011,"date":"2024-06-27T09:56:23","date_gmt":"2024-06-27T12:56:23","guid":{"rendered":"https:\/\/passarini.com.br\/deadline-for-udi-to-comply-with-anvisa-is-approaching\/"},"modified":"2024-07-01T10:11:31","modified_gmt":"2024-07-01T13:11:31","slug":"anvisa-new-optimized-procedure-for-medical-device-registration","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/anvisa-new-optimized-procedure-for-medical-device-registration\/","title":{"rendered":"Anvisa&#8217;s New Optimized Procedure for Medical Device Registration"},"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-margin-top:0px;--awb-margin-bottom: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-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-bg-size:cover;--awb-margin-bottom:0px;\"><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\/2020\/10\/1920x500_informativos_noticias-1.webp\" alt=\"Banner Informativos Blog da Passarini\" width=\"1560\" height=\"406\" class=\"wp-image-8654\" \/><\/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 class=\"headingpostinterno\">Anvisa&#8217;s New Optimized Procedure for Medical Device Registration<\/h2>\n<p>The National Sanitary Vigilance Agency (<a href=\"https:\/\/en.wikipedia.org\/wiki\/Brazilian_Health_Regulatory_Agency\">Anvisa<\/a>) has just announced a new optimized procedure for analyzing and deciding on applications for registration of medical devices and in vitro diagnostic devices. The announcement came via Normative Instruction &#8211; <strong>IN 290\/2024<\/strong>, which comes into force on June 3, 2024. This is a major change that promises to speed up the process of registering health products in Brazil, this brings benefits to both manufacturers and patients.<\/p>\n<p><strong>What is the Optimized Procedure?<\/strong><\/p>\n<p>The optimized procedure applies to high and maximum risk medical devices and in vitro diagnostic devices (<strong>Classes III and IV<\/strong>). To adopt the optimized procedure, the product must have prior authorization (proof of authorization\/registration) from a recognized Equivalent Foreign Regulatory Authority (in Portuguese, &#8220;Autoridade Reguladora Estrangeira Equivalente &#8211; <strong>AREE<\/strong>&#8220;) and be essentially identical to the one approved by the <strong>AREE<\/strong>.<\/p>\n<p><strong>What are the recognized AREEs and their required evidence?<\/strong><\/p>\n<\/div><ul style=\"--awb-line-height:23.8px;--awb-icon-width:23.8px;--awb-icon-height:23.8px;--awb-icon-margin:9.8px;--awb-content-margin:33.6px;--awb-circlecolor:#3bafbf;--awb-circle-yes-font-size:12.32px;\" class=\"fusion-checklist fusion-checklist-1 fusion-checklist-default type-icons\"><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p><span class=\"TextRun SCXW106307161 BCX0\" lang=\"PT-BR\" xml:lang=\"PT-BR\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW106307161 BCX0\"><strong>Australia:<\/strong> Australia <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW106307161 BCX0\">Therapeutic<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW106307161 BCX0\">Goods<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW106307161 BCX0\">Administration<\/span><span class=\"NormalTextRun SCXW106307161 BCX0\"> (TGA) \u2013 Australian Register <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW106307161 BCX0\">of<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW106307161 BCX0\">Therapeutic<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW106307161 BCX0\">Goods<\/span><span class=\"NormalTextRun SCXW106307161 BCX0\"> (ARTG);\u00a0<\/span><\/span><span class=\"EOP SCXW106307161 BCX0\" data-ccp-props=\"\">\u00a0<\/span><\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p><span class=\"TextRun SCXW87736755 BCX0\" lang=\"PT-BR\" xml:lang=\"PT-BR\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW87736755 BCX0\"><strong>Canada:<\/strong> Health Canada (HC) \u2013 Medical Device <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW87736755 BCX0\">License<\/span><span class=\"NormalTextRun SCXW87736755 BCX0\">;\u00a0<\/span><\/span><span class=\"EOP SCXW87736755 BCX0\" data-ccp-props=\"\">\u00a0<\/span><\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p><span class=\"TextRun SCXW97685579 BCX0\" lang=\"PT-BR\" xml:lang=\"PT-BR\" data-contrast=\"auto\"><strong><span class=\"NormalTextRun SCXW97685579 BCX0\">United States <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW97685579 BCX0\">of<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW97685579 BCX0\">America<\/span><\/strong><span class=\"NormalTextRun SCXW97685579 BCX0\"><strong> (USA):<\/strong> US Food <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW97685579 BCX0\">and<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW97685579 BCX0\">Drug<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW97685579 BCX0\">Administration<\/span><span class=\"NormalTextRun SCXW97685579 BCX0\"> (US FDA) \u2013 510(k) <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW97685579 BCX0\">Clearance<\/span><span class=\"NormalTextRun SCXW97685579 BCX0\">, <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW97685579 BCX0\">Premarket<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW97685579 BCX0\">Approval<\/span><span class=\"NormalTextRun SCXW97685579 BCX0\"> (PMA) <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW97685579 BCX0\">or<\/span><span class=\"NormalTextRun SCXW97685579 BCX0\"> 513(f)(2) \"De Novo\";<\/span><\/span><span class=\"EOP SCXW97685579 BCX0\" data-ccp-props=\"\">\u00a0<\/span><\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p><span class=\"TextRun SCXW222331964 BCX0\" lang=\"PT-BR\" xml:lang=\"PT-BR\" data-contrast=\"auto\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW222331964 BCX0\">Japan<\/span><span class=\"NormalTextRun SCXW222331964 BCX0\">: <\/span><\/strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW222331964 BCX0\">Japan<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW222331964 BCX0\">Ministry<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW222331964 BCX0\">of<\/span><span class=\"NormalTextRun SCXW222331964 BCX0\"> Health, Labor <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW222331964 BCX0\">and<\/span><span class=\"NormalTextRun SCXW222331964 BCX0\"> Welfare (MHLW) \u2013 <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW222331964 BCX0\">Premarket<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW222331964 BCX0\">approval<\/span><span class=\"NormalTextRun SCXW222331964 BCX0\"> (<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW222331964 BCX0\">Shonin<\/span><span class=\"NormalTextRun SCXW222331964 BCX0\">).<\/span><\/span><span class=\"EOP SCXW222331964 BCX0\" data-ccp-props=\"\">\u00a0<\/span><\/div><\/li><\/ul><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-image-element fusion-image-align-center in-legacy-container\" style=\"text-align:center;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><div class=\"imageframe-align-center\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><a href=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/06\/blog_in_290_2024_definicao-de-dispositivos-medicos-os-dispositivos-medicos-para-diagnostico-in-vitro_passarini_group-scaled.webp\" class=\"fusion-lightbox\" data-rel=\"iLightbox[Defini\u00e7\u00e3o De Dispositivos M\u00e9dicos Os Dispositivos M\u00e9dicos Para Diagn\u00f3stico In Vitro]\" data-caption=\"defini\u00e7\u00e3o de dispositivos m\u00e9dicos os dispositivos m\u00e9dicos para diagn\u00f3stico in vitro\" data-title=\"blog_in_290_2024_defini\u00e7\u00e3o de dispositivos m\u00e9dicos os dispositivos m\u00e9dicos para diagn\u00f3stico in vitro_passarini_group\" title=\"blog_in_290_2024_defini\u00e7\u00e3o de dispositivos m\u00e9dicos os dispositivos m\u00e9dicos para diagn\u00f3stico in vitro_passarini_group\"><img decoding=\"async\" width=\"300\" height=\"137\" alt=\"Definition of Medical Devices: In Vitro Diagnostic Medical Devices\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/06\/blog_in_290_2024_definicao-de-dispositivos-medicos-os-dispositivos-medicos-para-diagnostico-in-vitro_passarini_group-300x137.webp\" class=\"img-responsive wp-image-12018\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/06\/blog_in_290_2024_definicao-de-dispositivos-medicos-os-dispositivos-medicos-para-diagnostico-in-vitro_passarini_group-200x91.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/06\/blog_in_290_2024_definicao-de-dispositivos-medicos-os-dispositivos-medicos-para-diagnostico-in-vitro_passarini_group-300x137.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/06\/blog_in_290_2024_definicao-de-dispositivos-medicos-os-dispositivos-medicos-para-diagnostico-in-vitro_passarini_group-400x183.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/06\/blog_in_290_2024_definicao-de-dispositivos-medicos-os-dispositivos-medicos-para-diagnostico-in-vitro_passarini_group-600x274.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/06\/blog_in_290_2024_definicao-de-dispositivos-medicos-os-dispositivos-medicos-para-diagnostico-in-vitro_passarini_group-768x351.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/06\/blog_in_290_2024_definicao-de-dispositivos-medicos-os-dispositivos-medicos-para-diagnostico-in-vitro_passarini_group-800x366.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/06\/blog_in_290_2024_definicao-de-dispositivos-medicos-os-dispositivos-medicos-para-diagnostico-in-vitro_passarini_group-1024x468.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/06\/blog_in_290_2024_definicao-de-dispositivos-medicos-os-dispositivos-medicos-para-diagnostico-in-vitro_passarini_group-1200x549.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/06\/blog_in_290_2024_definicao-de-dispositivos-medicos-os-dispositivos-medicos-para-diagnostico-in-vitro_passarini_group-1536x702.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/06\/blog_in_290_2024_definicao-de-dispositivos-medicos-os-dispositivos-medicos-para-diagnostico-in-vitro_passarini_group-scaled.webp 1560w\" sizes=\"(max-width: 800px) 100vw, 1200px\" \/><\/a><\/span><\/div><\/div><div class=\"fusion-text fusion-text-2\"><p><span data-contrast=\"auto\">The recognized <strong>AREEs<\/strong> are all internationally renowned regulatory authorities, known for their rigorous safety and efficacy standards. The proof of registration or authorization issued by the authority that must refer to the medical device.<\/span><span data-ccp-props=\"\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">It is worth noting that having the device registered in the country from one of the <strong>AREEs<\/strong> established by ANVISA does not exclude submission in accordance with RDC's <strong>751\/2022<\/strong> or <strong>830\/2023<\/strong> and their updates.<\/span><span data-ccp-props=\"\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"\">Access IN 290\/2024 in full (Portuguese version), <strong>click the button below<\/strong>:<\/span><\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-align-block\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"width:calc(100%);\" target=\"_self\" href=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/06\/INSTRUCAO-NORMATIVA-IN-N\u00b0-290-DE-4-DE-ABRIL-DE-2024-INSTRUCAO-NORMATIVA-IN-N\u00b0-290-DE-4-DE-ABRIL-DE-2024-DOU-Imprensa-Nacional.pdf\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\"><span class=\"TextRun SCXW16031014 BCX0\" lang=\"PT-BR\" xml:lang=\"PT-BR\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW16031014 BCX0\">ACCESS IN 290 IN THE OFFICIAL GAZETTE<\/span><\/span> <\/span><\/a><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-3\"><p><span class=\"TextRun SCXW193810637 BCX0\" lang=\"PT-BR\" xml:lang=\"PT-BR\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW193810637 BCX0\"><span class=\"TextRun SCXW188455550 BCX0\" lang=\"PT-BR\" xml:lang=\"PT-BR\" data-contrast=\"auto\"><span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">Stay<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">tuned<\/span><span class=\"NormalTextRun SCXW188455550 BCX0\"> for more updates <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">on<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">this<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">and<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">other<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">important<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">health<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">topics<\/span><span class=\"NormalTextRun SCXW188455550 BCX0\">. <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">If<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">you<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">would<\/span><span class=\"NormalTextRun SCXW188455550 BCX0\"> like <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">to<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">find<\/span><span class=\"NormalTextRun SCXW188455550 BCX0\"> out more <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">about<\/span><span class=\"NormalTextRun SCXW188455550 BCX0\"> Passarini <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">Group&#8217;s<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">solutions<\/span><span class=\"NormalTextRun SCXW188455550 BCX0\"> for <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">the<\/span><span class=\"NormalTextRun SCXW188455550 BCX0\"> healthcare sector, <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">please<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">contact<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">us<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">and<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">request<\/span><span class=\"NormalTextRun SCXW188455550 BCX0\"> a quote. <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">We&#8217;ll<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">be<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">available<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">to<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">assist<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW188455550 BCX0\">you<\/span><\/span>, <\/span><\/span>simply contact us by email at:<span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"mailto:contato@passarini.com.br?subject=Enquadramento%20de%20porte%20ANVISA\">contato@passarini.com.br<\/a><\/strong>.<\/span><\/p>\n<h2><span style=\"color: #000000;\"><strong>Passarini Group<\/strong><\/span><\/h2>\n<p>Published on: 06\/27\/2024<\/p>\n<\/div><div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons has-taglines layout-floated layout-medium-floated layout-small-stacked\" style=\"background-color:#f6f6f6;--awb-separator-border-sizes:0px;--awb-layout:row;--awb-alignment-small:space-between;--awb-stacked-align-small:center;\" data-title=\"Passarini Group\" data-description=\"Anvisa&#039;s New Optimized Procedure for Medical Device Registration\r\nThe National Sanitary Vigilance Agency (Anvisa) has just announced a new optimized procedure for analyzing and deciding on applications for registration of medical devices and in vitro diagnostic devices. The announcement came via Normative Instruction - IN 290\/2024, which comes into force\" data-link=\"https:\/\/passarini.com.br\/en\/anvisa-new-optimized-procedure-for-medical-device-registration\"><h4 class=\"tagline\" style=\"color:#333333;\">To share<\/h4><div class=\"fusion-social-networks sharingbox-shortcode-icon-wrapper sharingbox-shortcode-icon-wrapper-1 boxed-icons\"><span><a href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fpassarini.com.br%2Fen%2Fanvisa-new-optimized-procedure-for-medical-device-registration&amp;t=Passarini%20Group\" target=\"_blank\" rel=\"noreferrer\" title=\"Facebook\" aria-label=\"Facebook\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"Facebook\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-facebook awb-icon-facebook\" style=\"color:#ffffff;background-color:#3b5998;border-color:#3b5998;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><span><a 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class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":16,"featured_media":12032,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67,216],"tags":[69,267],"class_list":["post-12011","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa-en","category-regulatorios-en","tag-anvisa-en","tag-medical-devices"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/12011","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\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/comments?post=12011"}],"version-history":[{"count":6,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/12011\/revisions"}],"predecessor-version":[{"id":12036,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/12011\/revisions\/12036"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/12032"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=12011"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=12011"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=12011"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}