{"id":7828,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/soutien-aux-affaires-reglementaires-canada\/"},"modified":"2026-02-04T16:47:26","modified_gmt":"2026-02-04T19:47:26","slug":"medical-device-license-health-canada","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/medical-device-license-health-canada\/","title":{"rendered":"Soutien aux affaires r\u00e9glementaires - Canada"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7828\" class=\"elementor elementor-7828 elementor-1637\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f832257 e-flex e-con-boxed e-con e-parent\" data-id=\"f832257\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3f54d7a elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"3f54d7a\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Licence de dispositif m\u00e9dical Sant\u00e9 Canada  <\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-66a32f4 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"66a32f4\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Obtaining a medical device license Health Canada requires a clear regulatory strategy and precise interaction with the authority. From establishment licensing to product-specific applications, Sobel supports manufacturers across different stages of the Canadian medical device licensing pathway.\"}]\" data-inline-monday=\"true\">L&rsquo;obtention d&rsquo;une licence pour un dispositif m\u00e9dical au Canada n\u00e9cessite une strat\u00e9gie r\u00e9glementaire claire et une interaction pr\u00e9cise avec l&rsquo;autorit\u00e9. De la licence d&rsquo;\u00e9tablissement aux demandes sp\u00e9cifiques de produits, Sobel soutient les fabricants \u00e0 travers les diff\u00e9rentes \u00e9tapes du parcours d&rsquo;homologation des dispositifs m\u00e9dicaux au Canada. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-27aa6ef elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"27aa6ef\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Obtenez l'aide d'un expert<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-acb2f13 e-flex e-con-boxed e-con e-parent\" data-id=\"acb2f13\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6d78e9a e-con-full e-flex e-con e-child\" data-id=\"6d78e9a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-6fd07d5 e-con-full e-transform e-flex e-con e-child\" data-id=\"6fd07d5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation_mobile&quot;:&quot;fadeIn&quot;,&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:96,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-109,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b5b3d16 elementor-widget elementor-widget-heading\" data-id=\"b5b3d16\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">Pour qui ?<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-79f0b14 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"79f0b14\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5269a13 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"5269a13\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Fabricants de dispositifs m\u00e9dicaux entrant sur le march\u00e9 canadien<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Entreprises candidates \u00e0 l'obtention d'un MDEL ou d'un MDL<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Les \u00e9quipes charg\u00e9es de la r\u00e9glementation qui g\u00e8rent les questions post\u00e9rieures \u00e0 la soumission ou la conformit\u00e9 continue<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Organisations ayant besoin de conseils r\u00e9glementaires \u00e0 la demande<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-25020e1 e-con-full e-flex e-con e-child\" data-id=\"25020e1\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation_mobile&quot;:&quot;fadeIn&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2f0d1eb elementor-widget elementor-widget-image\" data-id=\"2f0d1eb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"755\" height=\"1024\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png\" class=\"attachment-large size-large wp-image-18564\" alt=\"A portable vital signs monitor sits on a table. Office supplies are also on the table. It looks like a doctor&#039;s office.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png 755w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-221x300.png 221w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-768x1041.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services.png 1011w\" sizes=\"(max-width: 755px) 100vw, 755px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2dd60f9 e-flex e-con-boxed e-con e-parent\" data-id=\"2dd60f9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8df0eed elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"8df0eed\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Medical device licensing is a core regulatory requirement that supports lawful market access and ongoing compliance in Canada.\"}]\" data-inline-monday=\"true\">L&rsquo;homologation des dispositifs m\u00e9dicaux est une exigence r\u00e9glementaire fondamentale qui favorise l&rsquo;acc\u00e8s l\u00e9gal au march\u00e9 et la conformit\u00e9 continue au Canada.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d02b80e elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"d02b80e\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Obtenez de l'aide !<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d0d3358 e-flex e-con-boxed e-con e-parent\" data-id=\"d0d3358\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a53afd6 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"a53afd6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1259\" height=\"275\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.png\" class=\"attachment-full size-full wp-image-18570\" alt=\"Vector rectangle blue\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.png 1259w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-300x66.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-1024x224.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-768x168.png 768w\" sizes=\"(max-width: 1259px) 100vw, 1259px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b14d5d8 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"b14d5d8\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Pourquoi avez-vous besoin de ce service ?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0c82643 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"0c82643\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-69491da e-con-full e-flex e-con e-child\" data-id=\"69491da\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f48e452 elementor-widget elementor-widget-text-editor\" data-id=\"f48e452\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Medical device licensing is a legal requirement in Canada. Without the appropriate MDEL or MDL, manufacturers are not authorized to place medical devices on the Canadian market.\"}]\" data-inline-monday=\"true\">L&rsquo;homologation des dispositifs m\u00e9dicaux est une obligation l\u00e9gale au Canada. Sans la MDEL ou la MDL appropri\u00e9e, les fabricants ne sont pas autoris\u00e9s \u00e0 mettre des dispositifs m\u00e9dicaux sur le march\u00e9 canadien. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-18e13f0 e-con-full e-flex e-con e-child\" data-id=\"18e13f0\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b20a0ab elementor-widget elementor-widget-text-editor\" data-id=\"b20a0ab\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Missing, incorrect, or outdated licenses can result in regulatory holds, interruptions to commercial activities, or enforcement actions by Health Canada, directly impacting business continuity.\"}]\" data-inline-monday=\"true\">Des licences manquantes, incorrectes ou obsol\u00e8tes peuvent entra\u00eener des suspensions r\u00e9glementaires, des interruptions des activit\u00e9s commerciales ou des mesures d&rsquo;application de Sant\u00e9 Canada, ce qui a un impact direct sur la continuit\u00e9 de l&rsquo;activit\u00e9.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7d00f5a e-con-full e-flex e-con e-child\" data-id=\"7d00f5a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-01bc779 elementor-widget elementor-widget-text-editor\" data-id=\"01bc779\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Structured licensing and regulatory support helps manufacturers navigate application requirements, respond to regulatory interactions, and maintain compliance throughout the product lifecycle.\"}]\" data-inline-monday=\"true\">Une assistance structur\u00e9e en mati\u00e8re de licences et de r\u00e9glementation aide les fabricants \u00e0 s&rsquo;orienter dans les exigences d&rsquo;application, \u00e0 r\u00e9pondre aux interactions r\u00e9glementaires et \u00e0 maintenir la conformit\u00e9 tout au long du cycle de vie du produit.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-05f1f31 e-flex e-con-boxed e-con e-parent\" data-id=\"05f1f31\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-075aed1 e-con-full e-flex e-con e-child\" data-id=\"075aed1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0b294c1 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"0b294c1\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">La conformit\u00e9 r\u00e9glementaire au Canada commence par la mise en place des licences ad\u00e9quates<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d15c59b e-con-full e-flex e-con e-child\" data-id=\"d15c59b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0292f7b elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"0292f7b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Holding the appropriate medical device license is essential to legally place and maintain medical devices on the Canadian market. Licensing is not a formality \u2014 it is a condition for doing business in Canada.\"}]\" data-inline-monday=\"true\">Il est essentiel de d\u00e9tenir l&rsquo;homologation appropri\u00e9e pour placer et maintenir l\u00e9galement des dispositifs m\u00e9dicaux sur le march\u00e9 canadien. L&rsquo;homologation n&rsquo;est pas une formalit\u00e9 - c&rsquo;est une condition pour faire des affaires au Canada. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0eb3e62 e-flex e-con-boxed e-con e-parent\" data-id=\"0eb3e62\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0206fc2 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"0206fc2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Avec Sobel, l'homologation des dispositifs m\u00e9dicaux au Canada devient une voie r\u00e9glementaire claire et g\u00e9rable.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4562d89 elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"4562d89\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ucaddon_horizontal_timeline.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n<!-- start Horizontal Timeline -->\n\t\t<link id='font-awesome-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-all.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='font-awesome-4-shim-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-v4-shims.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='owl-carousel-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/owl-carousel-new\/assets\/owl.carousel.css' type='text\/css' rel='stylesheet' >\n\n<style>\/* widget: Horizontal Timeline *\/\n\n#uc_horizontal_timeline_elementor_4562d89 *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_4562d89{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_4562d89 .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_4562d89 .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_4562d89  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_4562d89  .carousel-nav button i{\n  position: absolute;\n     top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%);\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_4562d89 .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-item-bullet i, #uc_horizontal_timeline_elementor_4562d89 .ue-item-bullet svg{\n  position: absolute;\n  top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%); \n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_4562d89 .ue-carousel-item-holder{\n  display: flex;\n  flex-direction: column;\n  align-items: stretch;\n  height:100%;\n}\n\n<\/style>\n\n<div class=\"ue-horizontal-timeline\" id=\"uc_horizontal_timeline_elementor_4562d89\">\n     <div class=\"owl-carousel owl-theme uc-items-wrapper item-horizontal-timeline  \" id=\"uc_horizontal_timeline_elementor_4562d89\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-2510798\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >\u00c9valuation r\u00e9glementaire<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Nous examinons le contexte r\u00e9glementaire applicable et les informations fournies pour d\u00e9finir l'approche de soutien.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-547780b\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Soutien \u00e0 l'application ou au conseil<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Les demandes d'autorisation ou les conseils en mati\u00e8re de r\u00e9glementation sont fournis en fonction de l'\u00e9tendue du service s\u00e9lectionn\u00e9.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-2eb8ab0\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >R\u00e9sultats en mati\u00e8re de licences et de conformit\u00e9<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Vous b\u00e9n\u00e9ficiez d'un positionnement r\u00e9glementaire plus clair, d'une confiance accrue en mati\u00e8re de soumission et d'un soutien continu en mati\u00e8re de conformit\u00e9.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n\n  <\/div>\n<\/div>\n<!-- end Horizontal Timeline -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7370dc6 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"7370dc6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Commencez d\u00e8s maintenant !<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b3bfb99 animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"b3bfb99\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0269cdb elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"0269cdb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Quel service s'applique \u00e0 votre dispositif m\u00e9dical ?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e89f9ab elementor-widget elementor-widget-text-editor\" data-id=\"e89f9ab\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Medical device licensing in Canada involves different obligations depending on your role, device class, and regulatory stage. Sobel offers modular services that can be contracted individually or combined, allowing you to engage the level of support that best matches your regulatory needs:\"}]\" data-inline-monday=\"true\">L&rsquo;homologation d&rsquo;un dispositif m\u00e9dical au Canada implique diff\u00e9rentes obligations en fonction de votre r\u00f4le, de la classe du dispositif et de l&rsquo;\u00e9tape r\u00e9glementaire. Sobel propose des services modulaires qui peuvent \u00eatre contract\u00e9s individuellement ou combin\u00e9s, ce qui vous permet d&rsquo;engager le niveau de soutien qui correspond le mieux \u00e0 vos besoins en mati\u00e8re de r\u00e9glementation : <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bbed5aa e-flex e-con-boxed e-con e-child\" data-id=\"bbed5aa\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-9074ad8 e-con-full e-flex e-con e-child\" data-id=\"9074ad8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7ba878a elementor-widget elementor-widget-heading\" data-id=\"7ba878a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Demande de licence d'\u00e9tablissement pour les dispositifs m\u00e9dicaux (MDEL)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e6c0841 elementor-widget elementor-widget-text-editor\" data-id=\"e6c0841\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Ideal for companies required to hold an establishment license in Canada, this service supports manufacturers, importers, and distributors in preparing and submitting the MDEL application. Sobel assists with the completion of the applicable form and supports communication with Health Canada.\"}]\" data-inline-monday=\"true\">Id\u00e9al pour les entreprises tenues de d\u00e9tenir une licence d&rsquo;\u00e9tablissement au Canada, ce service aide les fabricants, les importateurs et les distributeurs \u00e0 pr\u00e9parer et \u00e0 soumettre la demande de licence d&rsquo;\u00e9tablissement. Sobel vous aide \u00e0 remplir le formulaire applicable et \u00e0 communiquer avec Sant\u00e9 Canada. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1d4ab97 e-con-full e-flex e-con e-child\" data-id=\"1d4ab97\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6c1460c elementor-widget elementor-widget-heading\" data-id=\"6c1460c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Demande d'homologation d'un dispositif m\u00e9dical (MDL) - Classes II \u00e0 IV<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-90be21c elementor-widget elementor-widget-text-editor\" data-id=\"90be21c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Designed for manufacturers applying for product-specific licensing, this service supports Class II, III, and IV medical device applications in Canada. Sobel assists with the preparation of the relevant application form and regulatory communication, helping align licensing activities with Health Canada requirements.\"}]\" data-inline-monday=\"true\">Con\u00e7u pour les fabricants qui demandent une homologation sp\u00e9cifique \u00e0 un produit, ce service soutient les demandes d&rsquo;homologation d&rsquo;appareils m\u00e9dicaux de classe II, III et IV au Canada. Sobel aide \u00e0 la pr\u00e9paration du formulaire de demande et de la communication r\u00e9glementaire, ce qui permet d&rsquo;aligner les activit\u00e9s d&rsquo;homologation sur les exigences de Sant\u00e9 Canada. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-617691f e-con-full e-flex e-con e-child\" data-id=\"617691f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-276a4b4 elementor-widget elementor-widget-heading\" data-id=\"276a4b4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Dossier complet - Demande d'homologation d'un dispositif m\u00e9dical de classe II<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bef221f elementor-widget elementor-widget-text-editor\" data-id=\"bef221f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Best suited for manufacturers seeking comprehensive regulatory support, this package covers the full Class II application process. Sobel supports regulatory classification, application preparation, gap analysis, submission, and interaction with Health Canada.\"}]\" data-inline-monday=\"true\">Destin\u00e9 aux fabricants \u00e0 la recherche d&rsquo;un soutien r\u00e9glementaire complet, ce paquet couvre l&rsquo;ensemble du processus d&rsquo;application de la classe II. Sobel prend en charge la classification r\u00e9glementaire, la pr\u00e9paration de la demande, l&rsquo;analyse des lacunes, la soumission et l&rsquo;interaction avec Sant\u00e9 Canada. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4b2c60b e-flex e-con-boxed e-con e-child\" data-id=\"4b2c60b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-79a01d6 e-con-full e-flex e-con e-child\" data-id=\"79a01d6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-41d394e elementor-widget elementor-widget-heading\" data-id=\"41d394e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Paquet partiel - Demande d'homologation d'un dispositif m\u00e9dical de classe II<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8194f97 elementor-widget elementor-widget-text-editor\" data-id=\"8194f97\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Intended for manufacturers who already have documentation in place, this service focuses on compiling and submitting a Class II medical device application based on existing materials. Sobel supports application structuring and submission activities, while additional consulting can be engaged if documentation gaps are identified.\"}]\" data-inline-monday=\"true\">Destin\u00e9 aux fabricants qui disposent d\u00e9j\u00e0 d&rsquo;une documentation, ce service se concentre sur la compilation et la soumission d&rsquo;une demande d&rsquo;homologation d&rsquo;un dispositif m\u00e9dical de classe II sur la base des documents existants. Sobel prend en charge la structuration de la demande et les activit\u00e9s de soumission, tandis que des conseils suppl\u00e9mentaires peuvent \u00eatre engag\u00e9s si des lacunes en mati\u00e8re de documentation sont identifi\u00e9es. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-168f6ba e-con-full e-flex e-con e-child\" data-id=\"168f6ba\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-37ef2b4 elementor-widget elementor-widget-heading\" data-id=\"37ef2b4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Consultation mensuelle<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9e8fb57 elementor-widget elementor-widget-text-editor\" data-id=\"9e8fb57\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Suitable for companies needing ongoing regulatory guidance, this service provides written support for day-to-day regulatory affairs questions. Manufacturers submit queries via Sobel\u2019s project management platform and receive structured written responses.\"}]\" data-inline-monday=\"true\">Adapt\u00e9 aux entreprises qui ont besoin d&rsquo;une orientation r\u00e9glementaire continue, ce service fournit une assistance \u00e9crite pour les questions quotidiennes relatives aux affaires r\u00e9glementaires. Les fabricants soumettent leurs questions via la plateforme de gestion de projet de Sobel et re\u00e7oivent des r\u00e9ponses \u00e9crites structur\u00e9es. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-08b1414 e-con-full e-flex e-con e-child\" data-id=\"08b1414\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5173f18 elementor-widget elementor-widget-heading\" data-id=\"5173f18\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Consultation g\u00e9n\u00e9rale sur les communications de Sant\u00e9 Canada<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fab0e94 elementor-widget elementor-widget-text-editor\" data-id=\"fab0e94\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Recommended for manufacturers receiving feedback or general communications from the authority, this service supports the interpretation of messages and regulatory expectations. Sobel provides strategic guidance to help companies understand regulatory context and define next steps.\"}]\" data-inline-monday=\"true\">Recommand\u00e9 aux fabricants qui re\u00e7oivent un retour d&rsquo;information ou des communications g\u00e9n\u00e9rales de l&rsquo;autorit\u00e9, ce service facilite l&rsquo;interpr\u00e9tation des messages et des attentes r\u00e9glementaires. Sobel fournit des conseils strat\u00e9giques pour aider les entreprises \u00e0 comprendre le contexte r\u00e9glementaire et \u00e0 d\u00e9finir les prochaines \u00e9tapes. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-349e8a9 elementor-widget elementor-widget-text-editor\" data-id=\"349e8a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"attributes\":{\"bold\":true},\"insert\":\"Our role is to provide clarity, structure, and regulatory guidance while maintaining clear boundaries between consulting support and manufacturer responsibilities.\"}]\" data-inline-monday=\"true\"><strong>Notre r\u00f4le est d&rsquo;apporter de la clart\u00e9, de la structure et des conseils en mati\u00e8re de r\u00e9glementation, tout en maintenant des limites claires entre l&rsquo;aide \u00e0 la consultation et les responsabilit\u00e9s du fabricant.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9c88cdf e-flex e-con-boxed e-con e-parent\" data-id=\"9c88cdf\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-068d379 e-con-full e-flex e-con e-child\" data-id=\"068d379\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2155e17 elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"2155e17\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b222b72 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"b222b72\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Services connexes <br><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-51541f8 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"51541f8\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Sobel supports manufacturers with additional regulatory services that complement licensing and support ongoing compliance in the Canadian market:\"}]\" data-inline-monday=\"true\">Sobel offre aux fabricants des services r\u00e9glementaires suppl\u00e9mentaires qui compl\u00e8tent l&rsquo;octroi de licences et soutiennent la conformit\u00e9 continue sur le march\u00e9 canadien :<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ba3be8b e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"ba3be8b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-3bf425a e-con-full e-flex e-con e-child\" data-id=\"3bf425a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2a16615 elementor-widget elementor-widget-heading\" data-id=\"2a16615\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Analyse des lacunes<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-772b08c elementor-widget elementor-widget-text-editor\" data-id=\"772b08c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Submission Readiness and Label Review for Medical Devices.\"}]\" data-inline-monday=\"true\">Pr\u00e9paration \u00e0 la soumission et examen de l&rsquo;\u00e9tiquetage des dispositifs m\u00e9dicaux.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-428bc83 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"428bc83\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/regulatory-submission-readiness\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Voir plus<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1a09e45 e-con-full e-flex e-con e-child\" data-id=\"1a09e45\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5cab040 elementor-widget elementor-widget-heading\" data-id=\"5cab040\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Documentation technique<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-86a35d8 elementor-widget elementor-widget-text-editor\" data-id=\"86a35d8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Structured and compliant documentation aligned with regulatory requirements.\"}]\" data-inline-monday=\"true\">Documentation structur\u00e9e et conforme aux exigences r\u00e9glementaires.<\/p><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b7dceed elementor-align-center elementor-widget elementor-widget-button\" data-id=\"b7dceed\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/medical-device-technical-documentation\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Voir plus<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7a8ac09 e-con-full e-flex e-con e-child\" data-id=\"7a8ac09\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-146b9fb elementor-widget elementor-widget-heading\" data-id=\"146b9fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u00c9valuation du risque toxicologique<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b0c1b3b elementor-widget elementor-widget-text-editor\" data-id=\"b0c1b3b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"TRA aligned with ISO 10993-18 and Health Canada expectations.\"}]\" data-inline-monday=\"true\">TRA conforme \u00e0 la norme ISO 10993-18 et aux attentes de Sant\u00e9 Canada.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-11bd196 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"11bd196\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Voir plus<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-57e675b e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"57e675b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-ba9234f e-con-full e-flex e-con e-child\" data-id=\"ba9234f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-313efbb e-con-full e-flex e-con e-child\" data-id=\"313efbb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a0abf05 elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"a0abf05\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Transformez les exigences complexes en mati\u00e8re d'autorisation en mesures r\u00e9glementaires claires<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c6d6c8a elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"c6d6c8a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Medical device licensing in Canada requires clarity, structure, and regulatory awareness. Sobel helps manufacturers navigate Health Canada requirements with confidence, supporting both initial applications and long-term regulatory compliance. Talk to our team and strengthen your medical device licensing strategy in Canada.\"}]\" data-inline-monday=\"true\">L&rsquo;homologation des dispositifs m\u00e9dicaux au Canada exige clart\u00e9, structure et connaissance de la r\u00e9glementation. Sobel aide les fabricants \u00e0 naviguer en toute confiance dans les exigences de Sant\u00e9 Canada, en soutenant \u00e0 la fois les demandes initiales et la conformit\u00e9 r\u00e9glementaire \u00e0 long terme. Parlez \u00e0 notre \u00e9quipe et renforcez votre strat\u00e9gie d&rsquo;homologation des dispositifs m\u00e9dicaux au Canada.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-51035e6 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"51035e6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Commencez d\u00e8s maintenant !<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-531fdce e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"531fdce\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-33a980d elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"33a980d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5411\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-5411\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Vous avez encore des questions ? Consultez notre FAQ <\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-5411\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-5411\"><p><b>1. Qu&rsquo;est-ce qu&rsquo;une licence de dispositif m\u00e9dical de Sant\u00e9 Canada et quand est-elle requise ?<\/b><\/p>\n<p>Une licence de dispositif m\u00e9dical de Sant\u00e9 Canada est une exigence l\u00e9gale pour placer et maintenir des dispositifs m\u00e9dicaux sur le march\u00e9 canadien. En fonction de votre r\u00f4le et de la classe de l&rsquo;appareil, vous pouvez avoir besoin d&rsquo;une licence d&rsquo;\u00e9tablissement (MDEL), d&rsquo;une licence de produit (MDL), ou des deux. <\/p>\n<p><b>2. Quelle est la diff\u00e9rence entre MDEL et MDL ?<\/b><\/p>\n<p>La licence d&rsquo;\u00e9tablissement pour les dispositifs m\u00e9dicaux (LEMM) s&rsquo;applique aux entreprises qui exercent des activit\u00e9s r\u00e9glement\u00e9es telles que l&rsquo;importation ou la distribution de dispositifs au Canada, tandis que la licence de dispositif m\u00e9dical (LDM) s&rsquo;applique au dispositif m\u00e9dical lui-m\u00eame. Toutes deux sont d\u00e9livr\u00e9es par Sant\u00e9 Canada, mais elles r\u00e9pondent \u00e0 des objectifs r\u00e9glementaires diff\u00e9rents. <\/p>\n<p><b>3. Les MDEL et MDL sont-ils obligatoires pour op\u00e9rer au Canada ?<\/b><\/p>\n<p>Oui. Le cas \u00e9ch\u00e9ant, la d\u00e9tention d&rsquo;une MDEL et\/ou d&rsquo;une MDL valide est obligatoire. Le fait d&rsquo;op\u00e9rer sans la licence requise peut entra\u00eener des mesures r\u00e9glementaires, l&rsquo;interruption des activit\u00e9s commerciales ou des restrictions d&rsquo;acc\u00e8s au march\u00e9.  <\/p>\n<p><b>4. Quelle est la diff\u00e9rence entre le paquet complet et le paquet partiel pour les applications de classe II ?<\/b><\/p>\n<p>Le paquet complet fournit une assistance r\u00e9glementaire de bout en bout, y compris la classification, l&rsquo;analyse des lacunes, la pr\u00e9paration de la demande, la soumission et l&rsquo;assistance \u00e0 l&rsquo;examen. L&rsquo;offre partielle se concentre sur la compilation et la soumission d&rsquo;une demande de classe II sur la base de la documentation existante. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Soutien r\u00e9glementaire pour l&rsquo;homologation des dispositifs m\u00e9dicaux par Sant\u00e9 Canada. Conseils r\u00e9glementaires sur les MDEL et MDL fournis par des experts. <\/p>\n","protected":false},"author":11,"featured_media":7224,"parent":8454,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-7828","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Licence de dispositif m\u00e9dical Sant\u00e9 Canada | Soutien r\u00e9glementaire<\/title>\n<meta name=\"description\" content=\"Soutien r\u00e9glementaire pour les licences de dispositifs m\u00e9dicaux de Sant\u00e9 Canada. 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