{"id":33470,"date":"2024-12-18T11:45:32","date_gmt":"2024-12-18T10:45:32","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/12\/18\/hong-kong-nuove-regole-per-le-domande-di-rinnovo\/"},"modified":"2024-12-20T10:36:33","modified_gmt":"2024-12-20T09:36:33","slug":"hong-kong-nuove-regole-per-le-domande-di-rinnovo","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/12\/18\/hong-kong-nuove-regole-per-le-domande-di-rinnovo\/","title":{"rendered":"Hong Kong: nuevas normas para las solicitudes de renovaci\u00f3n"},"content":{"rendered":"<p style=\"text-align: right;\">19\/12\/2024<\/p>\n<h2>A partir del <strong>1 de enero de 2025,<\/strong> la <strong>Divisi\u00f3n de Productos Sanitarios (MDD) de Hong Kong<\/strong> aplica nuevas normas para las solicitudes de renovaci\u00f3n de los registros de <strong>productos sanitarios<\/strong> que deben autorizarse. Los solicitantes de \u00abpersona responsable local\u00bb deben presentar la solicitud de renovaci\u00f3n del producto sanitario previsto <strong>al menos 12 semanas y hasta un a\u00f1o antes <\/strong>de que expire la aprobaci\u00f3n de registro actual, que tiene una validez de cinco a\u00f1os.<\/h2>\n<p>Si la Divisi\u00f3n de Productos Sanitarios no recibe la solicitud de renovaci\u00f3n dentro de este plazo, se considerar\u00e1 presentada fuera de plazo y la Divisi\u00f3n no la tramitar\u00e1. Si el registro actual expira o la Divisi\u00f3n de Productos Sanitarios recibe la solicitud de renovaci\u00f3n menos de 12 semanas antes de la expiraci\u00f3n, el solicitante tendr\u00e1 que presentar una nueva solicitud.<\/p>\n<p>Las disposiciones reflejan la necesidad de una planificaci\u00f3n anticipada y un periodo de caducidad adecuado para garantizar la continuidad en la disponibilidad de los productos sanitarios, evitando interrupciones en el suministro.<\/p>\n<p>Estas disposiciones se expresan en la gu\u00eda <strong>\u00ab<em>Overview of the Medical Device Administrative Control System &#8211; Guidance Notes<\/em>\u00ab: <em>GN &#8211; 01<\/em><\/strong>\u00ab, en relaci\u00f3n con la actualizaci\u00f3n de la <strong>cl\u00e1usula 5.15<\/strong> de <strong>30 de septiembre de 2024<\/strong>.<\/p>\n<p>La noticia sobre las nuevas normas para las solicitudes de renovaci\u00f3n de registros de productos sanitarios en Hong Kong a partir del 1 de enero de 2025 forma parte de las actualizaciones reglamentarias en curso del marco regulador de productos sanitarios de Hong Kong. La Divisi\u00f3n de Productos Sanitarios (MDD) est\u00e1 revisando sus documentos de orientaci\u00f3n para mejorar el cumplimiento y ajustarse a las normas internacionales. En particular, se est\u00e1n aplicando procedimientos para mejorar el proceso de registro y renovaci\u00f3n de productos, con la introducci\u00f3n del nuevo <em>Sistema de Informaci\u00f3n sobre Productos Sanitarios<\/em> (MDIS), disponible a partir de 2024 para facilitar las solicitudes en l\u00ednea.<\/p>\n<p><strong>FUENTE:<\/strong> <a href=\"https:\/\/www.mdd.gov.hk\/en\/whats-new\/mdacs-activities\/index-id-2330.html\"><strong>MDD Hong Kong<\/strong><\/a><\/p>\n<p>&gt;&gt;&gt; En cooperaci\u00f3n con agencias asociadas en m\u00e1s de 20 pa\u00edses fuera de Europa, Thema lleva a cabo actividades de <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/registrazioni-internazionali-extra-ue-dispositivi-medici-dm-e-medico-diagnostici-in-vitro-ivd\/\">preparaci\u00f3n y asistencia para el registro<\/a> de productos sanitarios y de diagn\u00f3sticos in vitro en varios pa\u00edses del mundo.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>19\/12\/2024 A partir del 1 de enero de 2025, la Divisi\u00f3n de Productos Sanitarios (MDD) de Hong Kong aplica nuevas normas  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":33420,"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-33470","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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