{"id":8143,"date":"2018-10-17T13:33:14","date_gmt":"2018-10-17T11:33:14","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8143"},"modified":"2023-01-24T15:05:21","modified_gmt":"2023-01-24T14:05:21","slug":"india-directrices-operativas-para-dispositivos-medicos-e-ivd","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/10\/17\/india-directrices-operativas-para-dispositivos-medicos-e-ivd\/","title":{"rendered":"INDIA: Directrices operativas para dispositivos m\u00e9dicos e IVD"},"content":{"rendered":"<p><strong><img decoding=\"async\" class=\"size-medium wp-image-8144 alignnone\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/10\/Health-map-300x282.jpg\" alt=\"\" width=\"300\" height=\"282\" \/><\/strong><\/p>\n<p><strong>Directriz para dispositivos m\u00e9dicos (DM)<\/strong><\/p>\n<p><span style=\"font-size: 1rem;\">Para apoyar a todas las partes interesadas en la implementaci\u00f3n del <\/span><a style=\"font-size: 1rem;\" href=\"https:\/\/mohfw.gov.in\/sites\/default\/files\/Medical%20Device%20Rules%2C%202017.pdf\" target=\"_blank\" rel=\"noopener\">Reglamento sobre dispositivos m\u00e9dicos 2017<\/a><span style=\"font-size: 1rem;\">,<\/span><span style=\"font-size: 1rem;\"> que entr\u00f3 en vigor en enero, CDSCO (Central Drugs Standard Control Organization), la Autoridad Reguladora de India emiti\u00f3 la<\/span><span style=\"font-size: 1rem;\">\u00a0<\/span><a style=\"font-size: 1rem;\" href=\"http:\/\/www.cdsco.nic.in\/writereaddata\/Guidance%20Document%20ipv.pdf\" target=\"_blank\" rel=\"noopener\"><em>draft guidance<\/em><\/a>,<em>\u00a0<\/em>la primera de este tipo. Este Documento define los requisitos reglamentarios, el sistema de clasificaci\u00f3n de los dispositivos m\u00e9dicos, las funciones y las responsabilidades de las Autoridades Reguladoras, los Organismos Notificados y los Organismos de Acreditaci\u00f3n, el proceso y la informaci\u00f3n requerida para el registro de los dispositivos m\u00e9dicos en la India, as\u00ed como las normas de calidad aplicables.<\/p>\n<p><strong>Directriz para dispositivos m\u00e9dicos de diagn\u00f3stico in vitro (IVD)<\/strong><\/p>\n<p>De conformidad con las disposiciones del Reglamento* y previa solicitud de la Autoridad Reguladora, el solicitante de registro de un nuevo dispositivo m\u00e9dico de diagn\u00f3stico in vitro debe presentar un Performance Evaluation Report (proporcionado por el fabricante y emitido por laboratorios acreditados) para el dispositivo en cuesti\u00f3n. La nueva <a href=\"http:\/\/cdsco.nic.in\/writereaddata\/Category%20wise%20testing%20laboratory%20list.pdf\" target=\"_blank\" rel=\"noopener\">Directriz<\/a> identifica para cada tipo de IVD la lista de laboratorios (instalaciones de ensayos) acreditados para realizar estas pruebas.<\/p>\n<p><strong>CDSCO cambiar\u00e1 su nombre<\/strong><\/p>\n<p><a href=\"http:\/\/cdsco.nic.in\/writereaddata\/public%20notice(1).pdf\" target=\"_blank\" rel=\"noopener\">CDSCO anunci\u00f3 el cambio de su nombre<\/a> y de su propio logotipo. En cuanto al cambio de nombre, se han propuesto \u00abNational Drug Authority (NDA)\u00bb y \u00abCentral Drug Authority (CDA)\u00bb.<\/p>\n<p>&nbsp;<\/p>\n<p>NOTA: * Cl\u00e1usula (h), P\u00e1rrafo (ii), Parte II, <em>Cuarto Anexo<\/em> del <em>Medical Devices Rules 2017<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Directriz para dispositivos m\u00e9dicos (DM) Para apoyar a todas las partes interesadas en la implementaci\u00f3n del Reglamento sobre dispositivos m\u00e9dicos 2017,  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","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-8143","post","type-post","status-publish","format-standard","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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