{"id":2846,"date":"2025-12-14T22:09:42","date_gmt":"2025-12-14T22:09:42","guid":{"rendered":"https:\/\/altrion-group.com\/?page_id=2846"},"modified":"2026-06-30T15:54:14","modified_gmt":"2026-06-30T15:54:14","slug":"mdl-mdel-canada","status":"publish","type":"page","link":"https:\/\/altrion-group.com\/it\/mdl-mdel-canada\/","title":{"rendered":"MDA &#038; MDEL CANADA"},"content":{"rendered":"<div id='av-layout-grid-1'  class='av-layout-grid-container av-7nloit-088d9e4d481f209b19bd665b92c5c355 entry-content-wrapper main_color av-flex-cells  avia-builder-el-0  el_before_av_section  avia-builder-el-first  av-cell-min-height av-cell-min-height-50  container_wrap fullsize'   data-av_minimum_height_pc='50'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-7iksy5-a447d38f3b1608c6cdc513626830cc32\">\n.flex_cell.av-7iksy5-a447d38f3b1608c6cdc513626830cc32{\nvertical-align:middle;\nbackground:url(https:\/\/altrion-group.com\/wp-content\/uploads\/2025\/12\/MDL-MDELcanada-1030x430.webp) 50% 50% no-repeat scroll #7faccd;\n}\n.responsive #top #wrap_all .flex_cell.av-7iksy5-a447d38f3b1608c6cdc513626830cc32{\npadding:0px 0px 0px 0px !important;\n}\n<\/style>\n<div class='flex_cell av-7iksy5-a447d38f3b1608c6cdc513626830cc32 av-gridrow-cell av_one_half no_margin  avia-builder-el-1  el_before_av_cell_one_half  avia-builder-el-first  content-align-middle av-zero-padding avia-full-stretch'  ><div class='flex_cell_inner'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lamlndza-867e3767e038d8ce182bfd3131e03a8b\">\n#top .hr.hr-invisible.av-lamlndza-867e3767e038d8ce182bfd3131e03a8b{\nheight:200px;\n}\n<\/style>\n<div  class='hr av-lamlndza-867e3767e038d8ce182bfd3131e03a8b hr-invisible  avia-builder-el-2  avia-builder-el-no-sibling '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-7eaf2t-13587f053fed9a03a610ec487eca6f29\">\n.flex_cell.av-7eaf2t-13587f053fed9a03a610ec487eca6f29{\nvertical-align:middle;\nbackground-color:#7faccd;\n}\n.responsive #top #wrap_all .flex_cell.av-7eaf2t-13587f053fed9a03a610ec487eca6f29{\npadding:50px 50px 50px 50px !important;\n}\n<\/style>\n<div class='flex_cell av-7eaf2t-13587f053fed9a03a610ec487eca6f29 av-gridrow-cell av_one_half no_margin  avia-builder-el-3  el_after_av_cell_one_half  avia-builder-el-last  content-align-middle'  ><div class='flex_cell_inner'><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lamls2p5-d458e826c42e93ed4003eb38da472290\">\n#top .av-special-heading.av-lamls2p5-d458e826c42e93ed4003eb38da472290{\npadding-bottom:10px;\ncolor:#ffffff;\nfont-size:39px;\n}\nbody .av-special-heading.av-lamls2p5-d458e826c42e93ed4003eb38da472290 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lamls2p5-d458e826c42e93ed4003eb38da472290 .av-special-heading-tag{\nfont-size:39px;\n}\n.av-special-heading.av-lamls2p5-d458e826c42e93ed4003eb38da472290 .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-lamls2p5-d458e826c42e93ed4003eb38da472290 .av-subheading{\nfont-size:15px;\ncolor:#ffffff;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-lamls2p5-d458e826c42e93ed4003eb38da472290 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-lamls2p5-d458e826c42e93ed4003eb38da472290 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div  class='av-special-heading av-lamls2p5-d458e826c42e93ed4003eb38da472290 av-special-heading-h1 custom-color-heading blockquote modern-quote  avia-builder-el-4  el_before_av_hr  avia-builder-el-first  av-inherit-size'><h1 class='av-special-heading-tag '  itemprop=\"headline\"  ><strong style=\"color: #fff; font-size: 36px;\">Licenze Canadesi MDL e MDEL<\/strong><\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lammyevo-b6b012543a8cd77fa59d26f507e6989a\">\n#top .hr.av-lammyevo-b6b012543a8cd77fa59d26f507e6989a{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-lammyevo-b6b012543a8cd77fa59d26f507e6989a .hr-inner{\nwidth:50px;\nborder-color:#ffffff;\n}\n<\/style>\n<div  class='hr av-lammyevo-b6b012543a8cd77fa59d26f507e6989a hr-custom  avia-builder-el-5  el_after_av_heading  el_before_av_textblock  hr-left hr-icon-no'><span class='hr-inner inner-border-av-border-fat'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-72sk5p-7799907f0db07ff7d037b986950eade5\">\n#top .av_textblock_section.av-72sk5p-7799907f0db07ff7d037b986950eade5 .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-72sk5p-7799907f0db07ff7d037b986950eade5 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><h2 class=\"av-special-heading-tag\"><strong>CONFORMIT\u00c0 HEALTH CANADA<br \/>\nPER DISPOSITIVI MEDICI<\/strong><\/h2>\n<p class=\"m-size-24 text-align-center size-30\">Accedi al mercato canadese con sicurezza.<\/p>\n<\/div><\/section><\/p>\n<\/div><\/div><\/div><div id='av_section_1'  class='avia-section av-uw1x1-7657275774aaf665c456ddf7d4e909d0 main_color avia-section-default avia-no-border-styling  avia-builder-el-7  el_after_av_layout_row  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-2846'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-syo8d-1f42d04d2346838f771ac9c9ace80e59\">\n.flex_column.av-syo8d-1f42d04d2346838f771ac9c9ace80e59{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-syo8d-1f42d04d2346838f771ac9c9ace80e59 av_four_fifth  avia-builder-el-8  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-a7e1p-6bdefd87f611a2ad6687b37efec4172a '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p><span style=\"font-weight: 400;\">Per vendere dispositivi medici in Canada, i fabbricanti devono conformarsi al <\/span><b>Medical Devices Regulations (SOR\/98-282) ai sensi del Food and Drugs Act<\/b><span style=\"font-weight: 400;\">. Il percorso regolatorio dipende dalla classe del dispositivo e dal ruolo dell&#8217;azienda coinvolta nella fabbricazione, importazione o distribuzione del dispositivo.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Per i <\/span><b>dispositivi di Classe I<\/b><span style=\"font-weight: 400;\">, \u00e8 richiesta una <\/span><b>Medical Device Establishment Licence (MDEL)<\/b><span style=\"font-weight: 400;\">, che pu\u00f2 essere detenuta dal fabbricante, dall&#8217;importatore o dal distributore. Per i <\/span><b>dispositivi di Classe II, III e IV<\/b><span style=\"font-weight: 400;\">, \u00e8 richiesta una <\/span><b>Medical Device Licence (MDL) rilasciata da Health Canada<\/b><span style=\"font-weight: 400;\">, oltre a una MDEL per lo stabilimento coinvolto nella distribuzione o importazione.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">ALTRION fornisce un supporto completo per i percorsi MDEL Canada e Medical Device Licence Canada, aiutando fabbricanti, importatori e distributori a gestire la classificazione, le licenze, i rinnovi e la conformit\u00e0 post-market. Tutti gli stabilimenti e i fabbricanti devono operare con un <\/span><b>Sistema di Gestione della Qualit\u00e0<\/b><span style=\"font-weight: 400;\"> conforme alla ISO 13485, preferibilmente certificato nell&#8217;ambito del Medical Device Single Audit Program (MDSAP).<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Percorso regolatorio canadese per i dispositivi medici<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Il primo passo per l&#8217;accesso al mercato canadese \u00e8 comprendere il <\/span><b>corretto percorso regolatorio<\/b><span style=\"font-weight: 400;\">. ALTRION supporta le aziende nel determinare se un dispositivo richiede una MDEL, una MDL o entrambe, in base alla classe del dispositivo e al ruolo dell&#8217;azienda nella catena di fornitura. Questa valutazione aiuta fabbricanti, importatori e distributori a evitare l&#8217;incertezza regolatoria e a preparare la <\/span><b>documentazione corretta<\/b><span style=\"font-weight: 400;\"> prima di immettere i dispositivi medici nel mercato canadese.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Classificazione del dispositivo<\/span><\/h2>\n<p><b>La classificazione del dispositivo<\/b><span style=\"font-weight: 400;\"> \u00e8 essenziale perch\u00e9 determina i <\/span><b>requisiti di licenza applicabili<\/b><span style=\"font-weight: 400;\">. ALTRION assiste nella classificazione del dispositivo e nella definizione del percorso regolatorio per i dispositivi medici di Classe I, II, III e IV. I dispositivi di Classe I generalmente richiedono una MDEL, mentre i dispositivi di Classe II, III e IV richiedono una MDL rilasciata da Health Canada. Una corretta classificazione aiuta a definire il <\/span><b>livello di documentazione<\/b><span style=\"font-weight: 400;\">, i <\/span><b>requisiti del sistema qualit\u00e0<\/b><span style=\"font-weight: 400;\"> e la <\/span><b>strategia di submission<\/b><span style=\"font-weight: 400;\"> necessari per la conformit\u00e0.<\/span><\/p>\n<\/div><\/section><\/div>\n<\/p>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lavkffm6-89a19ddf9e9265d6c9bb53d8c559b991\">\n.avia-section.av-lavkffm6-89a19ddf9e9265d6c9bb53d8c559b991{\nbackground-color:#22689e;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_2'  class='avia-section av-lavkffm6-89a19ddf9e9265d6c9bb53d8c559b991 main_color avia-section-default avia-no-border-styling  avia-builder-el-10  el_after_av_section  el_before_av_section  avia-bg-style-scroll av-minimum-height av-minimum-height-20 av-height-percent  container_wrap fullsize'   data-av_minimum_height_pc='20' data-av_min_height_opt='percent'><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-2846'><div class='entry-content-wrapper clearfix'>\n<div  class='flex_column av-5ocupa-adf4f9344bafb192a2e6bd8a6777a31c av_one_third  avia-builder-el-11  el_before_av_one_third  avia-builder-el-first  first flex_column_div  '     ><\/div><div  class='flex_column av-4h150e-095bae0466831e0353062471677caf9b av_one_third  avia-builder-el-12  el_after_av_one_third  el_before_av_one_third  flex_column_div  '     ><div  class='avia-button-wrap avia-button-center  avia-builder-el-13  avia-builder-el-no-sibling '>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lavki7rj-5aeea883d0b6578b0e80eb11b9f57148\">\n#top #wrap_all .avia-button.av-lavki7rj-5aeea883d0b6578b0e80eb11b9f57148:hover{\ncolor:white;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-lavki7rj-5aeea883d0b6578b0e80eb11b9f57148:hover .avia-svg-icon svg:first-child{\nfill:white;\nstroke:white;\n}\n<\/style>\n<a href='#modulo-contatto-mdl' class='av-icon-on-hover avia-color-theme-color avia-font-color-theme-color avia-button avia-button-fullwidth av-lavki7rj-5aeea883d0b6578b0e80eb11b9f57148 avia-icon_select-yes-right-icon avia-color-theme-color'   aria-label=\"Contattaci\"><span class='avia_iconbox_title' >Contattaci<\/span><span class='avia_button_icon avia_button_icon_right avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue805' data-av_iconfont='entypo-fontello' ><\/span><div class='av-button-description av-button-description-below'><p>Prenota il servizio<\/p>\n<\/div><span class='avia_button_background avia-button avia-button-fullwidth avia-color-theme-color-highlight'><\/span><\/a><\/div><\/div><div  class='flex_column av-2sjhy6-df14176a0df0a382aae77749df66c5ae av_one_third  avia-builder-el-14  el_after_av_one_third  avia-builder-el-last  flex_column_div  '     ><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lavk1b0k-623cdecfb0634f12877fe8c022c5d8fa\">\n.avia-section.av-lavk1b0k-623cdecfb0634f12877fe8c022c5d8fa{\nbackground-color:rgb(225, 225, 225);;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-lavk1b0k-623cdecfb0634f12877fe8c022c5d8fa main_color avia-section-default avia-no-border-styling  avia-builder-el-15  el_after_av_section  el_before_av_layout_row  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-2846'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2apcny-9895594a99a09ad5d97850d42df326c9\">\n.flex_column.av-2apcny-9895594a99a09ad5d97850d42df326c9{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\nbackground-color:#e1e1e1;\n}\n<\/style>\n<div  class='flex_column av-2apcny-9895594a99a09ad5d97850d42df326c9 av_four_fifth  avia-builder-el-16  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-lavk2t0l-856a369e2f0f62a8578d59a9bc3052af '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><div id=\"1246208796\" class=\"u_1246208796 dmNewParagraph\">\n<div>\n<h2><span style=\"font-weight: 400;\">Domande MDL per dispositivi di Classe II, III e IV<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Per i dispositivi di Classe II, III e IV, i fabbricanti devono ottenere una <\/span><b>Medical Device Licence da Health Canada<\/b><span style=\"font-weight: 400;\"> prima di vendere il dispositivo in Canada. ALTRION supporta la <\/span><b>preparazione e la presentazione delle domande MDL<\/b><span style=\"font-weight: 400;\">, aiutando i fabbricanti a organizzare le informazioni richieste e a gestire il processo di licenza. Questo supporto \u00e8 progettato per rendere il percorso Medical Device Licence Canada pi\u00f9 chiaro, strutturato e allineato alle aspettative di Health Canada.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Registrazione MDEL per fabbricanti, distributori e importatori<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">La <\/span><b>Medical Device Establishment Licence<\/b><span style=\"font-weight: 400;\"> \u00e8 richiesta per determinati fabbricanti, importatori e distributori coinvolti nella vendita, importazione o distribuzione di dispositivi medici in Canada. ALTRION supporta la registrazione MDEL per i dispositivi di Classe I e per gli stabilimenti coinvolti con dispositivi di classe superiore ove richiesto. Ci\u00f2 include aiutare le aziende a comprendere se necessitano di una MDEL, nella preparazione delle informazioni pertinenti e nel supporto al processo di registrazione.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Conformit\u00e0 ISO 13485 e MDSAP<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Tutti gli stabilimenti e i fabbricanti devono operare con un <\/span><b>Sistema di Gestione della Qualit\u00e0<\/b><span style=\"font-weight: 400;\"> conforme alla <\/span><b>ISO 13485<\/b><span style=\"font-weight: 400;\">, preferibilmente certificato nell&#8217;ambito del MDSAP. ALTRION supporta le aziende nell&#8217;<\/span><b>allineamento del proprio sistema qualit\u00e0 alle aspettative ISO 13485 e MDSAP<\/b><span style=\"font-weight: 400;\">, aiutandole a rafforzare la prontezza regolatoria per la conformit\u00e0 dei dispositivi medici in Canada. Questo \u00e8 particolarmente importante per i fabbricanti di dispositivi di Classe II, III e IV, dove i requisiti del sistema qualit\u00e0 sono strettamente connessi al processo di licenza.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Rinnovo delle licenze, sorveglianza post-market e segnalazione degli incidenti<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">La conformit\u00e0 dei dispositivi medici in Canada non termina con l&#8217;ottenimento della licenza. Le aziende devono <\/span><b>mantenere le proprie licenze<\/b><span style=\"font-weight: 400;\">, <\/span><b>gestire i rinnovi<\/b><span style=\"font-weight: 400;\"> e <\/span><b>continuare a monitorare le prestazioni del dispositivo<\/b><span style=\"font-weight: 400;\"> dopo l&#8217;immissione in commercio. ALTRION supporta il rinnovo delle licenze, la sorveglianza post-market e le attivit\u00e0 di segnalazione degli incidenti, aiutando fabbricanti e stabilimenti a mantenere la conformit\u00e0 continua ai requisiti di Health Canada. Questo supporto aiuta le aziende a mantenere attivo il proprio status regolatorio e a rispondere adeguatamente agli obblighi post-market.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Rappresentanza per fabbricanti non canadesi<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">I fabbricanti non canadesi possono necessitare di supporto locale per gestire la <\/span><b>comunicazione<\/b><span style=\"font-weight: 400;\">, la <\/span><b>rappresentanza<\/b><span style=\"font-weight: 400;\"> e i <\/span><b>processi regolatori<\/b><span style=\"font-weight: 400;\"> in Canada. ALTRION supporta la rappresentanza per i fabbricanti non canadesi attraverso la collaborazione con partner canadesi qualificati e rappresentanti locali. Questo aiuta le aziende internazionali a gestire il <\/span><b>percorso regolatorio canadese<\/b><span style=\"font-weight: 400;\"> con una <\/span><b>comunicazione pi\u00f9 chiara<\/b><span style=\"font-weight: 400;\"> e un <\/span><b>migliore coordinamento<\/b><span style=\"font-weight: 400;\"> durante le attivit\u00e0 di licenza e post-market.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Interfaccia diretta con Health Canada<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">La comunicazione con Health Canada \u00e8 una parte importante del processo di licenza. ALTRION fornisce supporto come interfaccia diretta con Health Canada, aiutando a gestire le <\/span><b>comunicazioni ufficiali<\/b><span style=\"font-weight: 400;\">, il <\/span><b>follow-up delle submission<\/b><span style=\"font-weight: 400;\"> e le <\/span><b>domande regolatorie<\/b><span style=\"font-weight: 400;\">. Questo servizio \u00e8 utile per le aziende che necessitano di un supporto strutturato durante la registrazione MDEL, le domande MDL, i rinnovi o le attivit\u00e0 di conformit\u00e0 post-market.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div><\/section><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mq6q8dei-cbb13474411ccaddd81671c4ada1734b\">\n.avia-section.av-mq6q8dei-cbb13474411ccaddd81671c4ada1734b{\nbackground-color:#ffffff;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_4'  class='avia-section av-mq6q8dei-cbb13474411ccaddd81671c4ada1734b main_color avia-section-default avia-no-border-styling avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-2846'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_four_fifth-6ed62927e07929c2f4f5c8529e712d7c\">\n.flex_column.av-av_four_fifth-6ed62927e07929c2f4f5c8529e712d7c{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_four_fifth-6ed62927e07929c2f4f5c8529e712d7c av_four_fifth first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-av_textblock-7a1af7d8f9790576b1769c0a9f0449ed '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h2><span style=\"font-weight: 400;\">FAQ su MDEL Canada e Medical Device Licence Canada<\/span><\/h2>\n<\/div><\/section><br \/>\n<div  class='togglecontainer av-av_toggle_container-0d23d522d20859f94d59c7485c451e65 toggle_close_all' >\n<section class='av_toggle_section av-av_toggle-86a8bcdb0eddd2883c1d3eca48a887a4'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{Tutto} \"  ><p id='toggle-toggle-id-1' data-fake-id='#toggle-id-1' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-1' data-slide-speed=\"200\" data-title=\"Cos&amp;apos;\u00e8 una MDEL in Canada?\" data-title-open=\"\" data-aria_collapsed=\"Clicca per espandere: Cos&amp;apos;\u00e8 una MDEL in Canada?\" data-aria_expanded=\"Fare clic per chiudere: Cos&amp;apos;\u00e8 una MDEL in Canada?\">Cos&apos;\u00e8 una MDEL in Canada?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-1' aria-labelledby='toggle-toggle-id-1' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p><span style=\"font-weight: 400;\">Una MDEL, o Medical Device Establishment Licence, \u00e8 una licenza richiesta per determinati fabbricanti, importatori e distributori coinvolti nella vendita, importazione o distribuzione di dispositivi medici in Canada. Per i dispositivi di Classe I, \u00e8 generalmente richiesta una MDEL.<\/span><\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-av_toggle-3a2600529bf665b8e8b7ab5f234c5bc8'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{Tutto} \"  ><p id='toggle-toggle-id-2' data-fake-id='#toggle-id-2' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-2' data-slide-speed=\"200\" data-title=\"Cos&amp;apos;\u00e8 una Medical Device Licence in Canada?\" data-title-open=\"\" data-aria_collapsed=\"Clicca per espandere: Cos&amp;apos;\u00e8 una Medical Device Licence in Canada?\" data-aria_expanded=\"Fare clic per chiudere: Cos&amp;apos;\u00e8 una Medical Device Licence in Canada?\">Cos&apos;\u00e8 una Medical Device Licence in Canada?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-2' aria-labelledby='toggle-toggle-id-2' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p><span style=\"font-weight: 400;\">Una Medical Device Licence, o MDL, \u00e8 rilasciata da Health Canada per i dispositivi medici di Classe II, III e IV. Autorizza la vendita di uno specifico dispositivo medico in Canada, a condizione che siano soddisfatti i requisiti regolatori applicabili.<\/span><\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-av_toggle-7aa9643e49f5b1872077bc169591d741'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{Tutto} \"  ><p id='toggle-toggle-id-3' data-fake-id='#toggle-id-3' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-3' data-slide-speed=\"200\" data-title=\"Qual \u00e8 la differenza tra MDEL e MDL?\" data-title-open=\"\" data-aria_collapsed=\"Clicca per espandere: Qual \u00e8 la differenza tra MDEL e MDL?\" data-aria_expanded=\"Fare clic per chiudere: Qual \u00e8 la differenza tra MDEL e MDL?\">Qual \u00e8 la differenza tra MDEL e MDL?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-3' aria-labelledby='toggle-toggle-id-3' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p><span style=\"font-weight: 400;\">Una MDEL si applica allo stabilimento coinvolto nella fabbricazione, importazione o distribuzione di dispositivi medici. Una MDL si applica al dispositivo medico stesso ed \u00e8 richiesta per i dispositivi di Classe II, III e IV.<\/span><\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-av_toggle-6709d92027f2b57cf54d92e65df6f69b'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{Tutto} \"  ><p id='toggle-toggle-id-4' data-fake-id='#toggle-id-4' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-4' data-slide-speed=\"200\" data-title=\"I dispositivi medici di Classe I necessitano di una MDEL?\" data-title-open=\"\" data-aria_collapsed=\"Clicca per espandere: I dispositivi medici di Classe I necessitano di una MDEL?\" data-aria_expanded=\"Fare clic per chiudere: I dispositivi medici di Classe I necessitano di una MDEL?\">I dispositivi medici di Classe I necessitano di una MDEL?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-4' aria-labelledby='toggle-toggle-id-4' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p><span style=\"font-weight: 400;\">S\u00ec. I dispositivi di Classe I generalmente richiedono una Medical Device Establishment Licence detenuta dal fabbricante, importatore o distributore coinvolto nella vendita del dispositivo in Canada.<\/span><\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-av_toggle-ec64923b01c49e64c12581b624f6b40e'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{Tutto} \"  ><p id='toggle-toggle-id-5' data-fake-id='#toggle-id-5' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-5' data-slide-speed=\"200\" data-title=\"La ISO 13485 \u00e8 richiesta per i dispositivi medici in Canada?\" data-title-open=\"\" data-aria_collapsed=\"Clicca per espandere: La ISO 13485 \u00e8 richiesta per i dispositivi medici in Canada?\" data-aria_expanded=\"Fare clic per chiudere: La ISO 13485 \u00e8 richiesta per i dispositivi medici in Canada?\">La ISO 13485 \u00e8 richiesta per i dispositivi medici in Canada?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-5' aria-labelledby='toggle-toggle-id-5' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p><span style=\"font-weight: 400;\">I fabbricanti e gli stabilimenti devono operare con un Sistema di Gestione della Qualit\u00e0 conforme alla ISO 13485, preferibilmente certificato nell&#8217;ambito del Medical Device Single Audit Program (MDSAP), a seconda del percorso regolatorio e della classe del dispositivo.<\/span><\/p>\n<\/div><\/div><\/div><\/section>\n<\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mq6qa2oy-0b14b801ff97652f60d96b3babb96f09\">\n#top .hr.hr-invisible.av-mq6qa2oy-0b14b801ff97652f60d96b3babb96f09{\nheight:100px;\n}\n<\/style>\n<div  class='hr av-mq6qa2oy-0b14b801ff97652f60d96b3babb96f09 hr-invisible'><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-av_textblock-7a1af7d8f9790576b1769c0a9f0449ed '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h2><span style=\"font-weight: 400;\">Perch\u00e9 scegliere ALTRION<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">ALTRION supporta le aziende con una <\/span><b>conoscenza approfondita del processo di licenza<\/b><span style=\"font-weight: 400;\"> e della <\/span><b>revisione delle MDL da parte di Health Canada<\/b><span style=\"font-weight: 400;\">. Attraverso la collaborazione con partner canadesi qualificati e rappresentanti locali, ALTRION aiuta fabbricanti, importatori e distributori a gestire il percorso regolatorio canadese con procedure pi\u00f9 chiare e tempi di approvazione pi\u00f9 prevedibili. Il supporto copre sia le licenze per i dispositivi che quelle per gli stabilimenti, offrendo alle aziende un approccio completo alla conformit\u00e0 MDEL Canada e Medical Device Licence Canada.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Documentazione fornita<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">ALTRION fornisce output regolatori pratici per supportare l&#8217;accesso al mercato canadese e la conformit\u00e0 continua.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Numeri di licenza MDL e\/o MDEL convalidati.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Log delle submission e comunicazioni ufficiali di Health Canada.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Assistenza per il rinnovo annuale e segnalazione di vigilanza.<\/span><\/li>\n<\/ul>\n<\/div><\/section><\/p><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av-layout-grid-2'  class='av-layout-grid-container av-2m8rml-cf1550da75c0a23f15e912f47bff0540 entry-content-wrapper main_color av-flex-cells  avia-builder-el-18  el_after_av_section  avia-builder-el-last  av-cell-min-height av-cell-min-height-25 grid-row-not-first  container_wrap fullsize'   data-av_minimum_height_pc='25'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2c9gfx-e7c714a2c4eecf09731b0ce122b582ff\">\n.flex_cell.av-2c9gfx-e7c714a2c4eecf09731b0ce122b582ff{\nvertical-align:middle;\nbackground-color:#22689e;\n}\n.responsive #top #wrap_all .flex_cell.av-2c9gfx-e7c714a2c4eecf09731b0ce122b582ff{\npadding:50px 50px 50px 50px !important;\n}\n<\/style>\n<div class='flex_cell av-2c9gfx-e7c714a2c4eecf09731b0ce122b582ff av-gridrow-cell av_one_half no_margin  avia-builder-el-19  el_before_av_cell_one_half  avia-builder-el-first  content-align-middle avia-full-stretch'  ><div class='flex_cell_inner'><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kguz1-b1480b9d494d47c00c70194fdc216f13\">\n#top .av-special-heading.av-kguz1-b1480b9d494d47c00c70194fdc216f13{\npadding-bottom:10px;\ncolor:#ffffff;\nfont-size:34px;\n}\nbody .av-special-heading.av-kguz1-b1480b9d494d47c00c70194fdc216f13 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-kguz1-b1480b9d494d47c00c70194fdc216f13 .av-special-heading-tag{\nfont-size:34px;\n}\n.av-special-heading.av-kguz1-b1480b9d494d47c00c70194fdc216f13 .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-kguz1-b1480b9d494d47c00c70194fdc216f13 .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-kguz1-b1480b9d494d47c00c70194fdc216f13 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-kguz1-b1480b9d494d47c00c70194fdc216f13 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div  class='av-special-heading av-kguz1-b1480b9d494d47c00c70194fdc216f13 av-special-heading-h2 custom-color-heading blockquote modern-quote modern-centered  avia-builder-el-20  el_before_av_hr  avia-builder-el-first  av-thin-font av-inherit-size'><h2 class='av-special-heading-tag '  itemprop=\"headline\"  ><strong>Ti interessa il mercato canadese?<\/strong><\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1k8np-a31b6b6b6f0cf69477c7c37e741a2466\">\n#top .hr.av-1k8np-a31b6b6b6f0cf69477c7c37e741a2466{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-1k8np-a31b6b6b6f0cf69477c7c37e741a2466 .hr-inner{\nwidth:50px;\nborder-color:#ffffff;\n}\n<\/style>\n<div  class='hr av-1k8np-a31b6b6b6f0cf69477c7c37e741a2466 hr-custom  avia-builder-el-21  el_after_av_heading  el_before_av_textblock  hr-center hr-icon-no'><span class='hr-inner inner-border-av-border-fat'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-aasqd-2f8a1807401651b6db6544716e41dc17\">\n#top .av_textblock_section.av-aasqd-2f8a1807401651b6db6544716e41dc17 .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-aasqd-2f8a1807401651b6db6544716e41dc17 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p style=\"text-align: center;\">Compila il modulo con la tua richiesta.<\/p>\n<p style=\"text-align: center;\">Ti contatteremo il prima possibile.<\/p>\n<\/div><\/section><\/p>\n<\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2aze9h-e7d67b752f4c05a190c3bec726a2b11c\">\n.flex_cell.av-2aze9h-e7d67b752f4c05a190c3bec726a2b11c{\nvertical-align:middle;\nbackground:url(https:\/\/altrion-group.com\/wp-content\/uploads\/2023\/01\/corporate-buildings-m-1030x687-_1_.webp) 0% 0% no-repeat scroll #22689e;\n}\n.responsive #top #wrap_all .flex_cell.av-2aze9h-e7d67b752f4c05a190c3bec726a2b11c{\npadding:30px 30px 30px 30px !important;\n}\n<\/style>\n<div class='flex_cell av-2aze9h-e7d67b752f4c05a190c3bec726a2b11c av-gridrow-cell av_one_half no_margin  avia-builder-el-23  el_after_av_cell_one_half  avia-builder-el-last  content-align-middle avia-full-stretch'  ><div class='flex_cell_inner'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lampn59y-d69ea6cd03beafbb8430e033f488e556\">\n.flex_column.av-lampn59y-d69ea6cd03beafbb8430e033f488e556{\npadding:20px 20px 20px 20px;\nbackground-color:#bfd6e6;\n}\n<\/style>\n<div  id=\"modulo-contatto-mdl\"  class='flex_column av-lampn59y-d69ea6cd03beafbb8430e033f488e556 av_four_fifth  avia-builder-el-24  avia-builder-el-no-sibling  first flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lamq769l-6198ca162e9bf78457dec726ab2c95de\">\n#top .av_textblock_section.av-lamq769l-6198ca162e9bf78457dec726ab2c95de .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-lamq769l-6198ca162e9bf78457dec726ab2c95de '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><h3 style=\"text-align: center;\"><strong>Form di contatto<\/strong><\/h3>\n<\/div><\/section><br \/>\n<form action=\"https:\/\/altrion-group.com\/it\/mdl-mdel-canada\/\" method=\"post\" data-fields-with-error=\"Sono stati riscontrati errori nei seguenti campi:\" class=\"avia_ajax_form av-form-labels-hidden   avia-builder-el-26  el_after_av_textblock  avia-builder-el-last   \" data-avia-form-id=\"1\" data-avia-redirect='https:\/\/altrion-group.com\/it\/messaggio-inviato\/' ><fieldset><p class='  first_form  form_element form_fullwidth' id='element_avia_1_1'><label for=\"avia_1_1\">Nome e Cognome <abbr class=\"required\" title=\"richiesto\">*<\/abbr><\/label> <input name=\"avia_1_1\" class=\"text_input is_empty\" type=\"text\" id=\"avia_1_1\" value=\"\"  placeholder='Nome e Cognome*'\/><\/p><p class='  first_form  form_element form_element_half' id='element_avia_2_1'><label for=\"avia_2_1\">Azienda <abbr class=\"required\" title=\"richiesto\">*<\/abbr><\/label> <input name=\"avia_2_1\" class=\"text_input is_empty\" type=\"text\" id=\"avia_2_1\" value=\"\"  placeholder='Azienda*'\/><\/p><p class='  form_element form_element_half' id='element_avia_3_1'><label for=\"avia_3_1\">Citt\u00e0 <abbr class=\"required\" title=\"richiesto\">*<\/abbr><\/label> <input name=\"avia_3_1\" class=\"text_input is_empty\" type=\"text\" id=\"avia_3_1\" value=\"\"  placeholder='Citt\u00e0*'\/><\/p><p class='  first_form  form_element form_element_half' id='element_avia_4_1'><label for=\"avia_4_1\">E-Mail <abbr class=\"required\" title=\"richiesto\">*<\/abbr><\/label> <input name=\"avia_4_1\" class=\"text_input is_email\" type=\"text\" id=\"avia_4_1\" value=\"\"  placeholder='E-Mail*'\/><\/p><p class='  form_element form_element_half' id='element_avia_5_1'><label for=\"avia_5_1\">Telefono<\/label> <input name=\"avia_5_1\" class=\"text_input \" type=\"text\" id=\"avia_5_1\" value=\"\"  placeholder='Telefono'\/><\/p><p class='  first_form  form_element form_fullwidth' id='element_avia_6_1'><label for=\"avia_6_1\" class=\"textare_label hidden textare_label_avia_6_1\">Scrivi qui la tua richiesta <abbr class=\"required\" title=\"richiesto\">*<\/abbr><\/label><textarea  placeholder='Scrivi qui la tua richiesta*' name=\"avia_6_1\" class=\"text_area is_empty\" cols=\"40\" rows=\"7\" id=\"avia_6_1\" ><\/textarea><\/p><p class=\"hidden\"><input 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