{"id":13024,"date":"2025-11-26T13:43:36","date_gmt":"2025-11-26T16:43:36","guid":{"rendered":"https:\/\/passarini.com.br\/anvisa-new-scheduling-system-compliance-rules\/"},"modified":"2025-11-26T16:10:51","modified_gmt":"2025-11-26T19:10:51","slug":"simplified-process-trap-anvisa-denials-class-i-ii","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/simplified-process-trap-anvisa-denials-class-i-ii\/","title":{"rendered":"The Simplified Process Trap: Why Do Classes I and II Generate More Rejections at ANVISA?"},"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\/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><b>The Myth of the &#8220;Easy&#8221; Process<\/b><\/h2>\n<p>In the medical device sector, there is a common and mistaken perception that the regulatory process for <strong>Class I and II<\/strong> products is simple and quick. Many companies have the false impression that &#8220;it seems easy, but it&#8217;s not!&#8221;. This simplistic view hides an alarming statistic that exposes a systemic failure in companies&#8217; preparation: most denials executed by ANVISA occur precisely for products in these lower-risk classes.<\/p>\n<p>Ignoring the hidden complexity of the <a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/anvisa-registration\/\">Notification<\/a> regime is a high-cost gamble. This article will demystify the process, reveal the technical requirements that often go unnoticed, and show why trying to navigate this scenario without specialized help can lead to a great loss of time and money.<\/p>\n<h3><b>Understanding ANVISA&#8217;s Risk Classification<\/b><\/h3>\n<p>Created by Law n\u00ba 9.782\/1999, the National Health Surveillance Agency (ANVISA) has the institutional purpose of promoting the protection of the population&#8217;s health. To fulfill this mission within the scope of medical devices, it establishes a control system based on the potential risk a product may offer to the patient or operator.<\/p>\n<p>As defined in Art. 5\u00ba of RDC n\u00ba <a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/resolucao-rdc-n-751-de-15-de-setembro-de-2022-430797145\">751\/2022<\/a>, devices are classified into four risk classes:<\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/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>Class I: Low risk<\/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>Class II: Medium risk<\/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>Class III: High risk<\/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>Class IV: Maximum risk<\/p>\n<\/div><\/li><\/ul><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-2\"><p>Based on this classification, <a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/resolucao-rdc-n-751-de-15-de-setembro-de-2022-430797145\">RDC 751\/2022<\/a> establishes two main control regimes in its Articles 6\u00ba and 7\u00ba:<\/p>\n<p><span class=\"x19la9d6 x1fc57z9 x6ikm8r x10wlt62 x19co3pv x11tp94h xfibh0p xiy17q3 x1xsqp64 x1lkfr7t xexx8yu xyri2b x18d9i69 x1c1uobl\"><span class=\"xrtxmta x1bhl96m\">&#x25aa;&#xfe0f;<\/span><\/span> Notification: Applicable to Class I and II devices.<\/p>\n<p><span class=\"x19la9d6 x1fc57z9 x6ikm8r x10wlt62 x19co3pv x11tp94h xfibh0p xiy17q3 x1xsqp64 x1lkfr7t xexx8yu xyri2b x18d9i69 x1c1uobl\"><span class=\"xrtxmta x1bhl96m\">&#x25aa;&#xfe0f;<\/span><\/span> Registration: Required for Class III and IV devices.<\/p>\n<p>It is precisely the term &#8220;<a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/anvisa-registration\/\">Notification<\/a>&#8221; that generates the false sense of simplicity and leads many companies to underestimate the complexity of the process. This underestimation stems from a fundamental lack of knowledge about the documentation required behind the scenes of the Notification process.<\/p>\n<\/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\"><img decoding=\"async\" width=\"400\" height=\"400\" alt=\"The Simplified Process Trap: Why Do Class I and II Products Lead ANVISA Denials?\" title=\"The Simplified Process Trap: Why Do Class I and II Products Lead ANVISA Denials?\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-400x400.webp\" class=\"img-responsive wp-image-13032\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-66x66.webp 66w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-150x150.webp 150w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-200x200.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-300x300.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-400x400.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-600x600.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-768x768.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-800x800.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-1024x1024.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN.webp 1080w\" sizes=\"(max-width: 800px) 100vw, 400px\" \/><\/span><\/div><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-3\" style=\"--awb-margin-top:10px;\"><div class=\"x_elementToProof\" data-olk-copy-source=\"MessageBody\">\n<h3><b>Company Registration and Prior Compliance: The Shortest Path to ANVISA<\/b><\/h3>\n<p>The first and most fundamental step to enable the sale of your product in the Brazilian market and gain access to ANVISA&#8217;s services is to ensure Company Registration and Prior Compliance.<\/p>\n<p>The notification of <strong>Class I and II<\/strong> products, although faster (routinely processed within up to 30 days after protocol), requires the company to be legally apt to operate, demonstrating its compliance even before product submission.<\/p>\n<h3><b>Conclusion: Stop Losing Time and Money<\/b><\/h3>\n<p>The regulatory path for <strong>Class I and II<\/strong> products, although seemingly simple on the surface, is full of technical requirements that, if ignored, lead to significant losses and frustration. Attempting to save money on proper regulatory advice almost always results in higher costs, launch delays, and unnecessary business risks.<\/p>\n<p>Stop losing time and money with fees and more fees, and truly seek a specialized company like Passarini Group.<\/p>\n<p>Contact us so we can present our services and enable your sales in the Brazilian market, now:\u00a0<strong><a href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/strong><\/p>\n<\/div>\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-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=\"ANVISA: Understand Why Low-Risk Products (Classes I and II) Are the Most Rejected\" data-description=\"The Myth of the &quot;Easy&quot; Process\r\nIn the medical device sector, there is a common and mistaken perception that the regulatory process for Class I and II products is simple and quick. Many companies have the false impression that &quot;it seems easy, but it&#039;s not!&quot;. This simplistic view hides an alarming statistic\" data-link=\"https:\/\/passarini.com.br\/en\/simplified-process-trap-anvisa-denials-class-i-ii\"><h4 class=\"tagline\" style=\"color:#333333;\">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%2Fsimplified-process-trap-anvisa-denials-class-i-ii&amp;t=ANVISA%3A%20Understand%20Why%20Low-Risk%20Products%20%28Classes%20I%20and%20II%29%20Are%20the%20Most%20Rejected\" 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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