{"id":8879,"date":"2019-02-18T10:33:26","date_gmt":"2019-02-18T09:33:26","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8879"},"modified":"2023-01-26T11:58:05","modified_gmt":"2023-01-26T10:58:05","slug":"singapore-hsa-aggiorna-le-guidance-relative-ai-dossier-di-registrazione-per-dispositivi-medici-e-ivd-2","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2019\/02\/18\/singapore-hsa-aggiorna-le-guidance-relative-ai-dossier-di-registrazione-per-dispositivi-medici-e-ivd-2\/","title":{"rendered":"SINGAPUR: HSA actualiza la gu\u00eda relacionada con los expedientes de registro para dispositivos m\u00e9dicos y diagn\u00f3stico in vitro DIV"},"content":{"rendered":"\r\n<p>Para facilitar la preparaci\u00f3n y el proceso de revisi\u00f3n de los <strong>dossier de registro de dispositivos m\u00e9dicos<\/strong> utilizando la Plantilla de dossier de env\u00edo de la <em>Association of Southeast Asian Nations Common Submission <\/em>(ASEAN CSDT), la Autoridad Reguladora de Singapur (HSA) se compromete a mejorar el contenido de Materiales propios disponibles en l\u00ednea.<\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image\"><img decoding=\"async\" class=\"wp-image-8882\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/02\/singapore-hsa-updated-guidelines-medical-device-ivd-registration-dossier-asean-csdt-1024x536.jpg\" alt=\"\" \/>\r\n<figcaption><em>HSA actualiza la gu\u00eda relacionada con los expedientes de registro para dispositivos m\u00e9dicos y DIV<\/em><\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n<p>Como parte del esfuerzo continuo para apoyar a sus partes interesadas, la intenci\u00f3n de HSA era proporcionar un dise\u00f1o simple e intuitivo, mejorar el acceso a la informaci\u00f3n (a trav\u00e9s de <em>gu\u00edas y plantillas<\/em>) y brindar mayor claridad a trav\u00e9s de documentos de registro comprensibles y concisos.<\/p>\r\n\r\n\r\n\r\n<p>Se realizaron <a href=\"https:\/\/www.hsa.gov.sg\/content\/hsa\/en\/Health_Products_Regulation\/Medical_Devices\/Regulatory_Updates.html\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"consultas p\u00fablicas (si apre in una nuova scheda)\">consultas p\u00fablicas<\/a> con las partes interesadas hasta el 24 de diciembre de 2018 y se llevaron a cabo los siguientes documentos:<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>Dos <em>directrices<\/em> renovadas para la preparaci\u00f3n de expedientes de registro para dispositivos m\u00e9dicos generales y dispositivos m\u00e9dicos de diagn\u00f3stico in vitro: \u00ab<em>Preparaci\u00f3n de una presentaci\u00f3n de registro de producto para dispositivos m\u00e9dicos generales <\/em>(GN-17) y <em>dispositivos m\u00e9dicos de diagn\u00f3stico in vitro<\/em> (GN-18) utilizando el CSDT de la ASEAN \u00ab;<\/li>\r\n<li>Dos gu\u00edas para la presentaci\u00f3n de solicitudes de registro en formato electr\u00f3nico para dispositivos m\u00e9dicos generales y para dispositivos m\u00e9dicos de diagn\u00f3stico in vitro: \u00ab<em>Gu\u00eda de presentaci\u00f3n electr\u00f3nica para dispositivos m\u00e9dicos generales y dispositivos m\u00e9dicos de diagn\u00f3stico in vitro para ASEAN CSDT e IMDRF ToC (International Medical Device Regulators Forum Table of Contents) presentaciones basadas en MEDICS<\/em> (Sistema de informaci\u00f3n y comunicaci\u00f3n de dispositivos m\u00e9dicos) \u00ab;<\/li>\r\n<li>Dos documentos t\u00e9cnicos relacionados con el contenido de los expedientes de registro para dispositivos m\u00e9dicos generales y para dispositivos m\u00e9dicos de diagn\u00f3stico in vitro: \u00ab<em>Contenido de una presentaci\u00f3n de registro de producto para dispositivos m\u00e9dicos generales (TR-01) y para In Vitro Diagnostic Medical (TR- 02) utilizando el CSDT de la ASEAN<\/em> \u00abque refleja el contenido actualizado de las dos gu\u00edas, GN-17 y GN-18.<\/li>\r\n<\/ul>\r\n","protected":false},"excerpt":{"rendered":"<p>Para facilitar la preparaci\u00f3n y el proceso de revisi\u00f3n de los dossier de registro de dispositivos m\u00e9dicos utilizando la Plantilla de  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23464,"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-8879","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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