{"id":24235,"date":"2022-10-21T09:13:17","date_gmt":"2022-10-21T07:13:17","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=24235"},"modified":"2023-01-24T15:08:55","modified_gmt":"2023-01-24T14:08:55","slug":"usa-fda-actualiza-las-tasas-por-el-2023","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-actualiza-las-tasas-por-el-2023\/","title":{"rendered":"USA: FDA actualiza las tasas por el 2023"},"content":{"rendered":"

El 5 de octubre, la FDA public\u00f3 el Medical Device User Fee Amendments (MDUFA)<\/em><\/a>, el documento que contiene las actualizaciones de las tasas de registro para la comercializaci\u00f3n de dispositivos m\u00e9dicos en los Estados Unidos.<\/h2>\n

En cuanto al Registro de Establecimientos, la tasa de registro anual para 2023 es de 6.493 d\u00f3lares<\/strong>, 821 d\u00f3lares m\u00e1s que en 2022, un aumento del 14%. No hay exenciones ni reducciones para las empresas m\u00e1s peque\u00f1as.<\/p>\n

El registro de establecimientos se aplica a todos los establecimientos de las organizaciones que participan en la fabricaci\u00f3n y comercializaci\u00f3n de dispositivos m\u00e9dicos que tienen su sede en los Estados Unidos o fuera con el fin de mantener la capacidad de comercializaci\u00f3n en el territorio.<\/p>\n

Para las distintas solicitudes, a continuaci\u00f3n se detallan las tasas a pagar a la FDA desde el 1 de octubre de 2022 hasta el 30 de septiembre de 2023:<\/strong><\/p>\n

\"fees\"<\/p>\n

 <\/p>\n

 <\/p>\n

 <\/p>\n

 <\/p>\n

 <\/p>\n

 <\/p>\n

 <\/p>\n

 <\/p>\n

*<\/strong> Small business: <\/strong>empresas reconocidas por el Center for Devices and Radiological Health (CDRH)<\/em><\/a> como peque\u00f1as empresas, por lo que se caracterizan por tener 100 millones de d\u00f3lares o menos en ingresos o ventas brutas\/a\u00f1o.<\/p>\n

** Procedimiento de notificaci\u00f3n previa a la comercializaci\u00f3n (PMN) o 510(k):<\/strong> la tasa se aplica a todos los tipos de 510(k) (tradicional, abreviado y especial).<\/p>\n

>> \u00bfC\u00f3mo podemos ayudarle a comercializar sus dispositivos en Estados Unidos?<\/strong><\/h3>\n

Con servicios de consulencia estrat\u00e9gico-regulatoria<\/a> y apoyo al registro<\/a> en los Estados Unidos<\/strong>, incluido el procedimiento 510(k),<\/a> Thema puede apoyarle en el cumplimiento de todos los requisitos previos y posteriores a la comercializaci\u00f3n del 21 CFR y de las normativas federales, lo que permite la entrada y distribuci\u00f3n de dispositivos sin problemas y de forma eficiente.<\/p>\n

Adem\u00e1s, con nuestros servicios de representante local, U.S. Agent<\/a> e U.S. Initial Importer<\/a>, que son obligatorios para el registro de establecimientos, podr\u00e1 comercializar sus dispositivos con la m\u00e1xima independencia y autonom\u00eda.<\/strong><\/p>\n

P\u00f3ngase en contacto con nosotros<\/a> para m\u00e1s informaci\u00f3n.<\/p>\n","protected":false},"excerpt":{"rendered":"

El 5 de octubre, la FDA public\u00f3 el Medical Device User Fee Amendments (MDUFA), el documento que contiene las actualizaciones de […]<\/p>\n","protected":false},"author":114,"featured_media":24166,"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-24235","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"\nUSA: FDA actualiza las tasas por el 2023 - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"description\" content=\"El 5 de octubre, la FDA public\u00f3 el Medical Device User Fee Amendments (MDUFA), el documento que contiene las actualizaciones de las tasas...\" \/>\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\/2022\/10\/21\/usa-fda-actualiza-las-tasas-por-el-2023\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"USA: FDA actualiza las tasas por el 2023 - 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