{"id":22038,"date":"2022-07-26T15:26:28","date_gmt":"2022-07-26T13:26:28","guid":{"rendered":"https:\/\/www.thema-med.eu\/?p=22038"},"modified":"2022-07-26T16:37:19","modified_gmt":"2022-07-26T14:37:19","slug":"tailandia-ruta-preferente-para-los-dispositivos-ya-registrados-en-singapur","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2022\/07\/26\/tailandia-ruta-preferente-para-los-dispositivos-ya-registrados-en-singapur\/","title":{"rendered":"TAILANDIA: ruta preferente para los dispositivos ya registrados en Singapur"},"content":{"rendered":"<p>El 20 de junio de 2022, la <strong>TFDA<\/strong> (FDA tailandesa) estableci\u00f3 la ampliaci\u00f3n del programa <strong>Singapur Reliance Route<\/strong>, probado inicialmente s\u00f3lo con productos de clase D\/clase 4, a todos los productos sanitarios de clase B, C y D.<\/p>\n<p>Con efecto inmediato y disfrutando de la v\u00eda preferente, la FDA tailandesa revisar\u00e1 las solicitudes en un m\u00e1ximo de <strong>60 d\u00edas<\/strong> laborables para los dispositivos que cumplan los requisitos de <strong>elegibilidad<\/strong>, es decir:<\/p>\n<ul>\n<li>Una vez superado el proceso de aprobaci\u00f3n para la comercializaci\u00f3n en Singapur en HSA;<\/li>\n<li>Estar activamente inscrito en el Registro de Dispositivos M\u00e9dicos de Singapur;<\/li>\n<li>Haber utilizado el formato del Expediente Com\u00fan de Presentaci\u00f3n (CSDT) para la solicitud de acceso al mercado.<\/li>\n<\/ul>\n<p><strong>\u00bfC\u00f3mo comercializar productos sanitarios en el mercado tailand\u00e9s con licencia en Singapur?<\/strong><\/p>\n<p>Los fabricantes deben designar un <strong>Representante Local Autorizado<\/strong> tailand\u00e9s para presentar una solicitud est\u00e1ndar de presentaci\u00f3n electr\u00f3nica a la Divisi\u00f3n de Control de Dispositivos M\u00e9dicos de la FDA tailandesa.<\/p>\n<p>Las solicitudes que utilicen la ruta de confianza de Singapur, adem\u00e1s de incluir exactamente los <strong>mismos<\/strong> <strong>documentos t\u00e9cnicos<\/strong> del CSDT presentados a la HSA en Singapur, tendr\u00e1n, sin embargo, que <strong>involucrar al Representante Local en Singapur<\/strong> para que la HSA (Autoridad Reguladora en Singapur) env\u00ede sus documentos de evaluaci\u00f3n a la TFDA (Autoridad Reguladora en Tailandia).<\/p>\n<p><strong>&gt;&gt;&gt; \u00bfDesea comercializar sus dispositivos en Tailandia?<\/strong><\/p>\n<p>Obtenga ahora <strong><u>asesoramiento estrat\u00e9gico en materia de reglamentaci\u00f3n<\/u> <\/strong>por parte de los expertos de Thema para comprender los <strong>requisitos y procedimientos<\/strong> necesarios para introducir los productos en el mercado tailand\u00e9s con rapidez y cumpliendo plenamente la normativa.<\/p>\n<p><strong>\u00bfEst\u00e1 decidido a seguir adelante? <\/strong>P\u00eddanos apoyo con el proceso de <strong><u>registro internacional<\/u> <\/strong>en la TFDA y, con el <strong><u>Representante Local<\/u><\/strong> Thema en Tailandia, podr\u00e1 comercializar el dispositivo con la <strong>m\u00e1xima independencia y autonom\u00eda<\/strong>.<\/p>\n<p><strong><u>P\u00f3ngase en contacto con nuestro Servicio de Atenci\u00f3n al Cliente<\/u><\/strong> para obtener informaciones.<\/p>\n<p>Fuentes:<\/p>\n<p><a href=\"https:\/\/www.fda.moph.go.th\/sites\/FDA_EN\/SitePages\/Medical.aspx?IDitem=LawsAndRegulations\">https:\/\/www.fda.moph.go.th\/sites\/FDA_EN\/SitePages\/Medical.aspx?IDitem=LawsAndRegulations<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El 20 de junio de 2022, la TFDA (FDA tailandesa) estableci\u00f3 la ampliaci\u00f3n del programa Singapur Reliance Route, probado inicialmente s\u00f3lo  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":22017,"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-22038","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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