{"id":20891,"date":"2022-04-29T12:32:45","date_gmt":"2022-04-29T10:32:45","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=20891"},"modified":"2022-05-02T14:58:10","modified_gmt":"2022-05-02T12:58:10","slug":"indonesia-ruta-de-registro-simplificada-para-los-dispositivos-de-clase-a","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2022\/04\/29\/indonesia-ruta-de-registro-simplificada-para-los-dispositivos-de-clase-a\/","title":{"rendered":"INDONESIA: ruta de registro simplificada para los dispositivos de clase A"},"content":{"rendered":"\n<p>El 10 de enero de 2022, el Ministerio de Sanidad de Indonesia anunci\u00f3 que\nhab\u00eda introducido <strong>una ruta de<\/strong> <strong>registro simplificada<\/strong> para <strong>determinados\nproductos sanitarios<\/strong> de la <strong>clase A<\/strong>, de acuerdo con el Reglamento 14\nde 2021.<\/p>\n\n\n\n<p>Para estos productos, ya no es necesario un procedimiento de registro\ncompleto, sino que basta con una <strong>notificaci\u00f3n<\/strong>, que puede presentarse a\ntrav\u00e9s del <strong>sistema de registro en l\u00ednea<\/strong> del portal <a href=\"http:\/\/regalkes.kemkes.go.id\/\">regalkes.kemkes.go.id<\/a>.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/04\/indonesia-nuovo-percorso-registrazione-dispositivi-medici-classe-a-1024x536.jpg\" alt=\"\" class=\"wp-image-20864\"\/><figcaption>INDONESIA: ruta de registro simplificada para los dispositivos de clase A<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u00bfQu\u00e9\nproductos sanitarios pueden registrarse en Indonesia mediante un procedimiento\nsimplificado?<\/strong><\/h2>\n\n\n\n<p>Actualmente, s\u00f3lo algunos productos sanitarios de la <strong>clase A de bajo\nriesgo<\/strong> pueden acogerse al procedimiento de notificaci\u00f3n simplificado:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>muletas;<\/li><li>hilo dental; <\/li><li>vendas el\u00e1sticas; <\/li><li>sillas de ruedas mec\u00e1nicas; <\/li><li>ropa de cama m\u00e9dica desechable; <\/li><li>andadores mec\u00e1nicos; <\/li><li>sacaleches manuales;<\/li><li>anillos de dentici\u00f3n; <\/li><li>bolsas de hielo; <\/li><li>ortesis de las extremidades y del tronco;<\/li><li>plantillas m\u00e9dicas; <\/li><li>visores oft\u00e1lmicos;<\/li><li>escalas de pacientes. <\/li><\/ul>\n\n\n\n<p>Si los productos sanitarios de la clase A enumerados anteriormente tienen\nregistros existentes, \u00e9stos seguir\u00e1n siendo v\u00e1lidos hasta su fecha de\ncaducidad. No obstante, en el caso de cambios en el producto que requieran\nnotificaci\u00f3n, deber\u00e1 realizarse un nuevo registro del producto mediante el\nprocedimiento simplificado.<\/p>\n\n\n\n<p>Con el procedimiento simplificado, los <strong>tiempos<\/strong> de notificaci\u00f3n se\nreducen considerablemente, lo que facilita la comercializaci\u00f3n de muchos\ndispositivos de bajo riesgo en el mercado indonesio.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u00bfNecesita\nayuda para comercializar sus productos sanitarios en Indonesia?<\/strong><\/h2>\n\n\n\n<p>Gracias a la colaboraci\u00f3n con agencias asociadas en varios pa\u00edses fuera de\nEuropa, nuestros expertos pueden ofrecerle un valioso apoyo en la preparaci\u00f3n\nde la notificaci\u00f3n y el registro de productos sanitarios ante las autoridades\nreguladoras locales.<\/p>\n\n\n\n<p><strong>>>> <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Descubra c\u00f3mo podemos ayudarle a comercializar sus productos en Indonesia. (si apre in una nuova scheda)\">Descubra c\u00f3mo podemos ayudarle a comercializar sus productos en Indonesia.<\/a><\/strong><\/p>\n\n\n\n<p>Para m\u00e1s informaci\u00f3n sobre el servicio, <strong><a href=\"mailto:sales@thema-med.com\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"p\u00f3ngase en contacto con nuestro Servicio de Atenci\u00f3n al Cliente (si apre in una nuova scheda)\">p\u00f3ngase en contacto con nuestro Servicio de Atenci\u00f3n al Cliente<\/a><\/strong>.<\/p>\n\n\n\n<p><em>Fuentes:<\/em><em><\/em><\/p>\n\n\n\n<p><a href=\"http:\/\/regalkes.kemkes.go.id\/\">Sistema de registro en l\u00ednea, Kementerian Kesehatan Republik Indonesia, 10 de enero de 2022<\/a><\/p>\n\n\n\n<p><a href=\"http:\/\/regalkes.kemkes.go.id\/index.php\/home\/fileDownload\/BERITA_FILE.pdf\/1000863\">Gu\u00eda del sistema de registro en l\u00ednea, Direcci\u00f3n General de Servicios Farmac\u00e9uticos y Dispositivos M\u00e9dicos, 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El 10 de enero de 2022, el Ministerio de Sanidad de Indonesia anunci\u00f3 que hab\u00eda introducido una ruta de registro simplificada  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[1,2],"tags":[],"class_list":["post-20891","post","type-post","status-publish","format-standard","hentry","category-news","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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