{"id":8026,"date":"2018-09-27T10:08:28","date_gmt":"2018-09-27T08:08:28","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8026"},"modified":"2023-01-24T15:05:22","modified_gmt":"2023-01-24T14:05:22","slug":"canada-renovacion-de-la-mdal-antes-del-1-de-noviembre","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/09\/27\/canada-renovacion-de-la-mdal-antes-del-1-de-noviembre\/","title":{"rendered":"CANAD\u00c1: renovaci\u00f3n de la MDAL antes del 1 de noviembre"},"content":{"rendered":"<p><img decoding=\"async\" class=\"size-medium wp-image-8021\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/09\/Canada-Health-300x200.jpg\" alt=\"\" width=\"300\" height=\"200\" \/><\/p>\n<p>Se acerca la fecha l\u00edmite para la renovaci\u00f3n de la <strong>Medical Device Active Licence (MDAL)<\/strong> en Canad\u00e1.<\/p>\n<p>De acuerdo con el <strong>punto 43(1) de la MDR SOR 98\/282<\/strong> canadiense, de hecho, antes del 1 de noviembre de cada a\u00f1o los fabricantes de dispositivos m\u00e9dicos con licencia, o el Corresponsal reglamentario canadiense respectivo si distintos, deben informar a Health Canada sobre la exactitud de los datos previamente comunicado sobre el fabricante y el dispositivo o dando evidencia de cualquier cambio.<\/p>\n<p>Al mismo tiempo, el fabricante tambi\u00e9n debe comunicar a Health Canada la cantidad de dispositivos vendidos en el periodo, en base a los cuales se calcula el impuesto a pagar por el mantenimiento.<\/p>\n<p>La contravenci\u00f3n de esta obligaci\u00f3n podr\u00eda resultar en la <strong>cancelaci\u00f3n de licencias no renovadas<\/strong> y la consiguiente interrupci\u00f3n de la venta de dispositivos en el territorio canadiense.<\/p>\n<p>&nbsp;<\/p>\n<p>Para m\u00e1s informaci\u00f3n:<\/p>\n<p><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/application-information\/guidance-documents\/guidance-document-medical-device-licence-renewal-fees-right-sell-licensed.html\" target=\"_blank\" rel=\"noopener\">https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/application-information\/guidance-documents\/guidance-document-medical-device-licence-renewal-fees-right-sell-licensed.html<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Se acerca la fecha l\u00edmite para la renovaci\u00f3n de la Medical Device Active Licence (MDAL) en Canad\u00e1. De acuerdo con el  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-8026","post","type-post","status-publish","format-standard","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CANAD\u00c1: renovaci\u00f3n de la MDAL antes del 1 de noviembre - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/es\/2018\/09\/27\/canada-renovacion-de-la-mdal-antes-del-1-de-noviembre\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CANAD\u00c1: renovaci\u00f3n de la MDAL antes del 1 de noviembre - Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"og:description\" content=\"Se acerca la fecha l\u00edmite para la renovaci\u00f3n de la Medical Device Active Licence (MDAL) en Canad\u00e1. 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