{"id":27164,"date":"2023-02-16T09:10:59","date_gmt":"2023-02-16T08:10:59","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=27164"},"modified":"2023-02-10T16:00:46","modified_gmt":"2023-02-10T15:00:46","slug":"canada-nuevas-tarifas-para-los-dispositivos-medicos-a-partir-del-1-de-abril-de-2023","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2023\/02\/16\/canada-nuevas-tarifas-para-los-dispositivos-medicos-a-partir-del-1-de-abril-de-2023\/","title":{"rendered":"CANAD\u00c1: nuevas tarifas para los dispositivos m\u00e9dicos a partir del 1 de abril de 2023"},"content":{"rendered":"

El Ministerio de Sanidad de Canad\u00e1 Health Canada<\/a> public\u00f3 el documento Fees in Respect of Drugs and Medical Devices Order<\/em><\/a>, el ajuste anual de las nuevas tarifas<\/strong> para Dispositivos M\u00e9dicos para el a\u00f1o fiscal 2023-2024<\/strong>, que entr\u00f3 en vigor el 1 de abril de 2020 y posteriormente se revis\u00f3 en marzo de 2021 durante la pandemia.<\/h2>\n

Las nuevas tasas ser\u00e1n aplicables a partir del 1 de abril de 2023<\/strong>.<\/p>\n

Seg\u00fan lo estipulado en la secci\u00f3n 4.1 del Fees in Respect of Drugs and Medical Devices Order<\/em>, cada tarifa en virtud de la Orden debe incrementarse anualmente de acuerdo con el \u00cdndice de Precios al Consumo (IPC). Las tarifas para el ejercicio 2023-2024 est\u00e1n sujetas a un IPC del<\/strong> 6,8%<\/strong>, lo que se ha traducido en un aumento de las tasas de solicitud de licencias de establecimiento y de dispositivos m\u00e9dicos.<\/p>\n

Las tasas de licencia de productos<\/strong> para Dispositivos M\u00e9dicos<\/strong> s\u00f3lo se aplican a las solicitudes de Dispositivos M\u00e9dicos de clase II, III y IV<\/strong>, seg\u00fan la normativa canadiense.<\/p>\n

Todos los dispositivos de estas clases deben obtener una licencia de producto (MDL o MDAL) para poder comercializarse en Canad\u00e1.<\/p>\n

Las tarifas para la Licencia de Establecimiento<\/strong> de Dispositivos M\u00e9dicos (MDEL – Medical Device Establishment Licence<\/em>) se expiden para actividades que implican la importaci\u00f3n o distribuci\u00f3n (venta) de Dispositivos M\u00e9dicos para Uso Humano en Canad\u00e1 y tambi\u00e9n se exigen a los Fabricantes de Dispositivos M\u00e9dicos de Clase I<\/strong> que no venden exclusivamente a trav\u00e9s de un Importador o Distribuidor canadiense autorizado. Se cobran tasas por la MDEL inicial, por las licencias anuales posteriores y por el restablecimiento de una MDEL. Las tasas se aplican por igual a los establecimientos extranjeros y nacionales, a excepci\u00f3n de determinadas exenciones.<\/p>\n

A continuaci\u00f3n encontrar\u00e1 un resumen y una tabla comparativa entre las tarifas de 2022<\/a> y las nuevas tarifas para Dispositivos M\u00e9dicos que entrar\u00e1n en vigor el 1 de abril de 2023:<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Table 7: Fees for examination of an application for a medical device licence (Schedule\u00a08)<\/strong><\/td>\n<\/tr>\n
Section in the\u00a0Fees in Respect of Drugs and Medical Devices Order<\/em><\/strong><\/td>\nCategory<\/strong><\/td>\nFee as of April\u00a01,\u00a02022<\/strong><\/td>\nFee as of April\u00a01,\u00a02023<\/strong><\/td>\n<\/tr>\n
Section\u00a060<\/td>\nApplications for Class II licence<\/td>\n$522<\/td>\n$589<\/td>\n<\/tr>\n
Applications for Class II licence amendment<\/td>\n$282<\/td>\n$302<\/td>\n<\/tr>\n
Applications for Class III licence<\/td>\n$10,679<\/td>\n$12,987<\/td>\n<\/tr>\n
Applications for Class III licence (near patient)<\/td>\n$20,723<\/td>\n$27,666<\/td>\n<\/tr>\n
Applications for Class III licence amendment\u00a0\u2014\u00a0changes in manufacturing<\/td>\n$3,070<\/td>\n$4,098<\/td>\n<\/tr>\n
Applications for Class III licence amendment\u00a0\u2014\u00a0significant changes not related to manufacturing<\/td>\n$8,780<\/td>\n$10,425<\/td>\n<\/tr>\n
Applications for Class IV licence<\/td>\n$25,955<\/td>\n$28,165<\/td>\n<\/tr>\n
Applications for Class IV licence amendment\u00a0\u2014\u00a0changes in manufacturing<\/td>\n$3,070<\/td>\n$4,098<\/td>\n<\/tr>\n
Applications for Class IV licence amendment\u00a0\u2014\u00a0significant changes not related to manufacturing<\/td>\n$12,128<\/td>\n$14,902<\/td>\n<\/tr>\n
Applications for Class II,\u00a0III or IV licence or licence amendment\u00a0\u2014\u00a0private label medical device<\/td>\n$152<\/td>\n$163<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n\n\n\n\n\n
Table 8: Fees for examination of an application for an establishment licence\u00a0\u2014\u00a0medical devices<\/strong><\/td>\n<\/tr>\n
Section in the\u00a0Fees in Respect of Drugs and Medical Devices Order<\/em><\/strong><\/td>\nFee category<\/strong><\/td>\nFee as of April\u00a01,\u00a02022<\/strong><\/td>\nFee as of April\u00a01,\u00a02023<\/strong><\/td>\n<\/tr>\n
Section\u00a071<\/td>\nMedical device<\/td>\n$4,737<\/td>\n$5,060<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n\n\n\n\n\n
Table 9: Fees for right to sell licensed Class II, III or IV medical devices<\/strong><\/td>\n<\/tr>\n
Section in the\u00a0Fees in Respect of Drugs and Medical Devices Order<\/em><\/strong><\/td>\nFee category<\/strong><\/td>\nFee as of April\u00a01,\u00a02022<\/strong><\/td>\nFee as of April\u00a01,\u00a02023<\/strong><\/td>\n<\/tr>\n
Section\u00a077<\/td>\nMedical device<\/td>\n$394<\/td>\n$421<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Para no perderse las \u00faltimas actualizaciones normativas en Canad\u00e1 y en todo el mundo, suscr\u00edbase a nuestra Newsletter<\/a>.<\/p>\n

>> \u00bfNecesita ayuda para comercializar sus dispositivos en Canad\u00e1?<\/strong><\/h3>\n

Los expertos de Thema est\u00e1n disponibles con servicios de consulencia estrat\u00e9gico-regulatoria<\/a> para preparar y presentar la documentaci\u00f3n requerida, para actuar como Canadian Regulatory Correspondent<\/a> as\u00ed como para asistir con el registro<\/a> de dispositivos m\u00e9dicos en el territorio.<\/p>\n

Cont\u00e1ctanos<\/a> para m\u00e1s informaci\u00f3n.<\/p>\n

Fuentes: https:\/\/gazette.gc.ca\/rp-pr\/p1\/2022\/2022-12-17\/html\/notice-avis-eng.html#na4<\/a><\/p>\n

https:\/\/gazette.gc.ca\/rp-pr\/p1\/2022\/2022-12-17\/pdf\/g1-15651.pdf<\/a><\/p>\n

https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/funding-fees\/fees-respect-human-drugs-medical-devices.html<\/a><\/p>\n

https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/fees.html<\/a><\/p>\n

https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/funding-fees\/fees-respect-human-drugs-medical-devices\/medical-device-licence-application-review-funding-fees-drugs-health-products.html<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

El Ministerio de Sanidad de Canad\u00e1 Health Canada public\u00f3 el documento Fees in Respect of Drugs and Medical Devices Order, el […]<\/p>\n","protected":false},"author":114,"featured_media":27175,"comment_status":"closed","ping_status":"closed","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-27164","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"\nCANAD\u00c1: nuevas tarifas para los dispositivos m\u00e9dicos a partir del 1 de abril de 2023 - 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\/2023\/02\/16\/canada-nuevas-tarifas-para-los-dispositivos-medicos-a-partir-del-1-de-abril-de-2023\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CANAD\u00c1: nuevas tarifas para los dispositivos m\u00e9dicos a partir del 1 de abril de 2023 - 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