{"id":35381,"date":"2026-02-17T12:53:24","date_gmt":"2026-02-17T11:53:24","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=35381"},"modified":"2026-02-26T15:53:33","modified_gmt":"2026-02-26T14:53:33","slug":"corea-del-sur-lanza-una-via-rapida-para-dispositivos-medicos-innovadores","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2026\/02\/17\/corea-del-sur-lanza-una-via-rapida-para-dispositivos-medicos-innovadores\/","title":{"rendered":"Corea del Sur lanza una v\u00eda r\u00e1pida para dispositivos m\u00e9dicos innovadores"},"content":{"rendered":"<p>El 26 de enero de 2026, el Ministerio de Salud y Bienestar (MOHW) y el Ministerio de Seguridad de Alimentos y Medicamentos (MFDS) lanzaron el nuevo sistema de acceso r\u00e1pido al mercado para dispositivos m\u00e9dicos innovadores: <a href=\"https:\/\/www.mohw.go.kr\/board.es?mid=a10503010200&amp;bid=0027&amp;act=view&amp;list_no=1488836&amp;tag=&amp;nPage=1\"><strong>\u201cMarket Immediate Entry Medical Technology\u201d<\/strong>.<\/a><\/p>\n<p>La reforma, precedida por una fase piloto finalizada en 2025, entr\u00f3 en vigor el 26 de enero tras las enmiendas al \u201cReglamento sobre la Evaluaci\u00f3n de Nuevas Tecnolog\u00edas M\u00e9dicas\u201d y a las \u201cNormas sobre la Autorizaci\u00f3n, Notificaci\u00f3n y Revisi\u00f3n de Dispositivos M\u00e9dicos\u201d.<\/p>\n<p>Esta v\u00eda permite que los dispositivos m\u00e9dicos innovadores che han <strong>superado una evaluaci\u00f3n cl\u00ednica de nivel internacional por parte del MFDS<\/strong> entren en el mercado y sean utilizados por las instituciones sanitarias inmediatamente despu\u00e9s de su aprobaci\u00f3n, <strong>sin necesidad de una evaluaci\u00f3n independiente de Nueva Tecnolog\u00eda M\u00e9dica (NMT)<\/strong>. En concreto, el producto obtiene acceso directo al uso cl\u00ednico justo despu\u00e9s de la autorizaci\u00f3n del MFDS.<\/p>\n<h3><strong>Reducci\u00f3n de los plazos de aprobaci\u00f3n<\/strong><\/h3>\n<p>Gracias a este sistema, el tiempo de entrada en el sistema sanitario surcoreano se reduce dr\u00e1sticamente, pasando de un m\u00e1ximo de 490 d\u00edas a solo <strong>80-140 d\u00edas<\/strong>. Esta ruta acelerada est\u00e1 reservada para dispositivos que cumplen criterios de innovaci\u00f3n espec\u00edficos y que ya han sido sometidos a una evaluaci\u00f3n cl\u00ednica reforzada durante la fase de autorizaci\u00f3n del MFDS.<\/p>\n<h3><strong>\u00c1mbito de aplicaci\u00f3n y categor\u00edas<\/strong><\/h3>\n<p>El marco regulatorio se aplica a <strong>199 categor\u00edas<\/strong> de dispositivos, con un enfoque especial en las tecnolog\u00edas avanzadas:<\/p>\n<ul>\n<li><strong>113 dispositivos digitales<\/strong>, incluidos los Software como Dispositivo M\u00e9dico (SaMD) basados en Inteligencia Artificial.<\/li>\n<li><strong>83 reactivos de diagn\u00f3stico in vitro.<\/strong><\/li>\n<li><strong>Dispositivos rob\u00f3ticos<\/strong>, como sistemas quir\u00fargicos automatizados, robots asistenciales y ortop\u00e9dicos, y exoesqueletos motorizados.<\/li>\n<\/ul>\n<h3><strong>Referencias regulatorias y actualizaciones<\/strong><\/h3>\n<p>La reforma se ha implementado mediante enmiendas coordinadas a dos conjuntos de normas:<\/p>\n<ul>\n<li><strong>Enmiendas a las Normas sobre la Evaluaci\u00f3n de Nuevas Tecnolog\u00edas M\u00e9dicas (NMT), <\/strong>bajo el MOHW<strong>:<\/strong> definen como \u201ctecnolog\u00edas m\u00e9dicas de entrada inmediata\u201d a aquellos dispositivos que han superado la evaluaci\u00f3n cl\u00ednica reforzada durante la autorizaci\u00f3n del MFDS como tecnolog\u00edas m\u00e9dicas innovadoras.<\/li>\n<li><strong>Enmiendas a las Normas sobre la Autorizaci\u00f3n, Notificaci\u00f3n y Revisi\u00f3n de Dispositivos M\u00e9dicos:<\/strong> establecen los criterios para la evaluaci\u00f3n cl\u00ednica, exigiendo datos completos que incluyan ensayos institucionales, literatura cient\u00edfica y datos de la vida real (<strong>Real-World Data<\/strong>).<\/li>\n<\/ul>\n<h3><strong>El impulso de Asia hacia la innovaci\u00f3n<\/strong><\/h3>\n<p>Con el nuevo sistema \u201c<strong>Market Immediate Entry Medical Technology\u201d,<\/strong> Corea del Sur pretende acelerar el acceso de los pacientes a las tecnolog\u00edas innovadoras. La introducci\u00f3n de esta v\u00eda r\u00e1pida refleja una tendencia m\u00e1s amplia de los pa\u00edses asi\u00e1ticos, que est\u00e1n invirtiendo decididamente en el sector MedTech. Junto a las reformas coreanas, China tambi\u00e9n est\u00e1 implementando s\u00f3lidas pol\u00edticas de apoyo a los dispositivos avanzados, con incentivos espec\u00edficos para la integraci\u00f3n de la inteligencia artificial y la digitalizaci\u00f3n en los procesos de diagn\u00f3stico.<\/p>\n<p>Esta combinaci\u00f3n de nuevos marcos regulatorios y apoyo tecnol\u00f3gico est\u00e1 posicionando a los pa\u00edses asi\u00e1ticos como un <strong>mercado de lanzamiento preferente<\/strong> para las tecnolog\u00edas m\u00e9dicas de pr\u00f3xima generaci\u00f3n.<\/p>\n<p><strong>&gt;&gt;&gt; Complife <\/strong>apoya a los fabricantes internacionales para aprovechar estas nuevas oportunidades de acceso al mercado surcoreano, a trav\u00e9s de servicios de consultor\u00eda estrate\u0301gico-regulatoria y de registro internacional.<\/p>\n<p><strong>FUENTE:<\/strong><br \/>\n<a href=\"https:\/\/www.mohw.go.kr\/board.es?mid=a10503010200&amp;bid=0027&amp;act=view&amp;list_no=1488836&amp;tag=&amp;nPage=1\">Ministerio de Salud y Bienestar (MOHW)<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El 26 de enero de 2026, el Ministerio de Salud y Bienestar (MOHW) y el Ministerio de Seguridad de Alimentos y  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":35349,"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-35381","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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