{"id":26456,"date":"2023-01-19T16:52:20","date_gmt":"2023-01-19T15:52:20","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=26456"},"modified":"2023-01-24T15:08:53","modified_gmt":"2023-01-24T14:08:53","slug":"reino-unido-la-mhra-aumenta-las-tasas-de-registro-de-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2023\/01\/19\/reino-unido-la-mhra-aumenta-las-tasas-de-registro-de-dispositivos-medicos\/","title":{"rendered":"Reino Unido: la MHRA aumenta las tasas de registro de Dispositivos M\u00e9dicos"},"content":{"rendered":"<h2>Durante la <a href=\"https:\/\/www.gov.uk\/government\/consultations\/consultation-on-proposals-for-changes-to-the-medicines-and-healthcare-products-regulatory-agencys-statutory-fees\">consulta<\/a> que finaliz\u00f3 el 23 de noviembre, la MHRA present\u00f3 <a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1101660\/MHRA-Statutory-Fees-Consultation.pdf\">propuestas de modifica<\/a>ci\u00f3n por las tasas de registro obligatorio de Dispositivos M\u00e9dicos que se aplicar\u00edan a partir del <strong>1 de abril de 2023<\/strong>.<\/h2>\n<p>Se propusieron <strong>tres ajustes<\/strong>, que se detallan a continuaci\u00f3n:<\/p>\n<ul>\n<li><strong>Aumento del 10% de la indexaci\u00f3n<\/strong> de las tasas obligatorias de la Agencia. La indexaci\u00f3n est\u00e1 vinculada a los costes de personal incrementados en un 10% desde la \u00faltima revisi\u00f3n de tasas en 2016. La lista de tasas propuesta, que refleja el aumento del 10% en la indexaci\u00f3n, figura en el <a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1101660\/MHRA-Statutory-Fees-Consultation.pdf\">Anexo B \u2013 MHRA <em>statutory fee proposals<\/em> (Cuadro 1);<\/a><\/li>\n<li><strong>aumento adicional de 61 tasas<\/strong> por servicios que requieren recuperaci\u00f3n de costes. El incremento de cada tasa var\u00eda en funci\u00f3n del coste de la actividad, las tareas y la carga de trabajo necesarias para prestar el servicio. La lista de tasas afectadas por este aumento basado en los costes figura en el <a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1101660\/MHRA-Statutory-Fees-Consultation.pdf\">Anexo B \u2013 MHRA <em>statutory fee proposals<\/em> (Cuadro 2);<\/a><\/li>\n<li><strong>Introducci\u00f3n de 22 nuevas tasas<\/strong> para garantizar que la Agencia recupere adecuadamente los costes de la actividad reguladora en todos sus servicios, en l\u00ednea con los principios del <em>HM Treasury<\/em> sobre la gesti\u00f3n del dinero p\u00fablico, tras los \u00faltimos cambios de tasas en 2016\/2017 para Medicamentos y 2017\/2018 para Dispositivos M\u00e9dicos. Las tarifas de estos servicios se revisar\u00e1n durante los pr\u00f3ximos 12 meses y, en caso necesario, se ajustar\u00e1n en <strong>abril de 2024<\/strong> para garantizar que se aproximen lo m\u00e1s posible a la recuperaci\u00f3n de costes. La lista de las 22 nuevas tasas propuestas figura en el <a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1101660\/MHRA-Statutory-Fees-Consultation.pdf\">Anexo B \u2013 MHRA <em>statutory fee proposals<\/em> (Cuadro 3).<\/a><\/li>\n<\/ul>\n<p>Est\u00e1 previsto que las tasas entren en vigor en <strong>abril de 2023<\/strong> y la recuperaci\u00f3n de costes se supervisar\u00e1 durante el primer a\u00f1o tras su aplicaci\u00f3n para garantizar que las nuevas tasas cubren los costes reales.<\/p>\n<p>Para no perderse las \u00faltimas actualizaciones sobre las directrices de la MHRA y el panorama normativo en el Reino Unido, <a href=\"https:\/\/md-24.us20.list-manage.com\/subscribe?u=672feff85a65d12563810beed&amp;id=3c9da60174\"><strong>suscr\u00edbase a nuestro bolet\u00edn<\/strong><\/a>.<\/p>\n<p>Si necesita apoyo para comercializar sus productos sanitarios e IVD en el Reino Unido cumpliendo plenamente la normativa, elija a Thema como su <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/servicio-de-uk-responsible-person-uk-rp\/\"><strong>Persona Responsable en el Reino Unido (UKRP)<\/strong><\/a>.<\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/contactanos-2\/\"><strong>Cont\u00e1ctanos<\/strong><\/a> para m\u00e1s informaci\u00f3n.<\/p>\n<p>Fuente: <a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1101660\/MHRA-Statutory-Fees-Consultation.pdf\">https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1101660\/MHRA-Statutory-Fees-Consultation.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Durante la consulta que finaliz\u00f3 el 23 de noviembre, la MHRA present\u00f3 propuestas de modificaci\u00f3n por las tasas de registro obligatorio  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":26436,"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-26456","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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