{"id":4486,"date":"2019-04-08T11:43:28","date_gmt":"2019-04-08T14:43:28","guid":{"rendered":"http:\/\/passarini.com.br\/rdc-no-270_2019-notification-of-risk-class-i-medical-devices-2\/"},"modified":"2021-09-01T14:04:43","modified_gmt":"2021-09-01T17:04:43","slug":"notification-process-for-class-i-products","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/notification-process-for-class-i-products\/","title":{"rendered":"Notification process for class I products"},"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-3-1536x400.webp\" \/><\/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\"><p><span style=\"color: #000000;\"><strong>Guidance of the Notification process for class I products<\/strong><\/span><\/p>\n<p class=\"Default\"><span style=\"font-size: 10.0pt; font-family: 'Arial',sans-serif;\"><a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/anvisa-registrationrecord\">Anvisa<\/a> published on Tuesday (2\/4) a document with guidelines, in portuguese, for the regulated sector about the new standard of notification process of the medical devices and IVD class of risk I, regulated by the RDC 270\/2019.<\/span><\/p>\n<p class=\"Default\"><span style=\"font-size: 10.0pt; font-family: 'Arial',sans-serif;\">The <span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2019\/04\/orienta%C3%A7%C3%B5es-sobre-produtos-de-menor-risco.pdf\">document<\/a><\/strong><\/span> contains:<\/span><\/p>\n<ul>\n<li class=\"Default\"><span style=\"font-size: 10.0pt; font-family: 'Arial',sans-serif;\">Clarification of the standard;<\/span><\/li>\n<li class=\"Default\"><span style=\"font-size: 10.0pt; font-family: 'Arial',sans-serif;\">Information about the electronic petition process for products class I;<\/span><\/li>\n<li class=\"Default\"><span style=\"font-size: 10.0pt; font-family: 'Arial',sans-serif;\">In addition to a scheme of frequently asked questions on the subject.<\/span><\/li>\n<\/ul>\n<p class=\"Default\"><b><span style=\"font-size: 10.0pt;\">\u00a0<\/span><\/b><span style=\"font-size: 10.0pt; font-family: 'Arial',sans-serif;\">With the new resolution, as of <span style=\"color: #000000;\">\u00a0<\/span><\/span><span style=\"color: #000000;\"><b><span style=\"font-size: 10pt; font-family: Arial, sans-serif;\">May 2<\/span><\/b><\/span> <span style=\"font-size: 10.0pt; font-family: 'Arial',sans-serif;\">, medical devices and IVD of class I,\u00a0 should be submitted to a notification process, instead of a process of registration.<\/span><\/p>\n<p class=\"Default\"><span style=\"color: #000000;\"><b><i><span style=\"font-size: 10pt; font-family: Arial, sans-serif;\">Note*: Products class of risk II remain subject to registration, as is currently the case.<\/span><\/i><\/b><\/span><\/p>\n<p class=\"Default\"><span style=\"color: #000000;\"><em><b><u><span style=\"font-size: 10.0pt; font-family: 'Arial',sans-serif;\">Product Notification<\/span><\/u><\/b><\/em><\/span><\/p>\n<p class=\"Default\"><span style=\"font-size: 10.0pt; font-family: 'Arial',sans-serif;\">The publication of the notification number will be in <\/span><span style=\"color: #000000;\"><b><span style=\"font-size: 10pt; font-family: Arial, sans-serif;\">30 days<\/span><\/b><\/span> <span style=\"font-size: 10.0pt; font-family: 'Arial',sans-serif;\">after payment of the ANVISA fee, only by the Anvisa website.<\/span><\/p>\n<p class=\"Default\"><span style=\"font-size: 10.0pt; font-family: 'Arial',sans-serif;\">As of the validity of the new standard, the processes for regularization of medical devices of risk class I that are awaiting the first manifestation of Anvisa will be treated as a notification system.<\/span><\/p>\n<p class=\"Default\"><span style=\"font-size: 10.0pt; font-family: 'Arial',sans-serif;\">Tecnhical demand process in analisys, will only be included in this scheme if they are accepted through the granting of the notification number.<\/span><\/p>\n<p class=\"Default\"><span style=\"font-size: 10.0pt; font-family: 'Arial',sans-serif;\">Anvisa further clarifies that the notification process does not require prior technical analysis for the regularization of the product, but does not dispense with granting the notification number.<\/span><\/p>\n<p class=\"Default\"><span style=\"color: #000000;\"><b><i><span style=\"font-size: 10pt; font-family: Arial, sans-serif;\">Note**: Only with the grant of this number can the product be industrialized, exposed for sale or delivered to consumption.<\/span><\/i><\/b><\/span><\/p>\n<p>For more information and explanations about it, send us an e-mail:\u00a0<span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/strong><\/span><\/p>\n<p><strong><span style=\"color: #000000;\">Source:<\/span>\u00a0<\/strong>ANVISA<\/p>\n<p>Published: 04\/08\/2019<\/p>\n<\/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=\"Guidance of the Notification process for class I products\r\nAnvisa published on Tuesday (2\/4) a document with guidelines, in portuguese, for the regulated sector about the new standard of notification process of the medical devices and IVD class of risk I, regulated by the\" data-link=\"https:\/\/passarini.com.br\/en\/notification-process-for-class-i-products\/\"><h4 class=\"tagline\" style=\"color:#333333;\">To share<\/h4><div class=\"fusion-social-networks 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