{"id":27538,"date":"2023-04-12T10:36:26","date_gmt":"2023-04-12T08:36:26","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=27538"},"modified":"2023-04-12T10:40:17","modified_gmt":"2023-04-12T08:40:17","slug":"india-publicada-la-lista-de-laboratorios-acreditados","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2023\/04\/12\/india-publicada-la-lista-de-laboratorios-acreditados\/","title":{"rendered":"INDIA: publicada la lista de laboratorios acreditados"},"content":{"rendered":"<h2>El pasado 7 de marzo, la <em>Organizaci\u00f3n Central de Control de Normas de Medicamentos (CDSCO)<\/em> public\u00f3 la <strong>Notificaci\u00f3n No.29\/Misc\/03\/2019-DC(211) <em>Lista del Laboratorio de Pruebas de Dispositivos M\u00e9dicos (MDTL) certificado bajo MDR 2017<\/em><\/strong> que incluye la lista de <strong>laboratorios acreditados<\/strong> (Laboratorio de Pruebas de Dispositivos M\u00e9dicos o MDTL) para realizar pruebas y <strong>evaluaciones de seguridad precl\u00ednica<\/strong> en Dispositivos M\u00e9dicos y Dispositivos M\u00e9dicos de Diagn\u00f3stico In Vitro, bajo el Art\u00edculo 81 de la Regla de Dispositivos M\u00e9dicos 2017 que entr\u00f3 en vigor el 1 de enero de 2018.<\/h2>\n<p>Dentro de la <strong>lista<\/strong> se encuentra toda la <strong>informaci\u00f3n necesaria<\/strong> para <strong>identificar<\/strong> al laboratorio acreditado encargado de realizar los ensayos a efectos del registro del dispositivo ante la CDSCO, como el nombre, la direcci\u00f3n del laboratorio y el n\u00famero de registro.<\/p>\n<p>El <strong>documento<\/strong> identifica los criterios de identificaci\u00f3n del laboratorio de ensayo, las categor\u00edas de productos que se manejan, las limitaciones inherentes a la clase de riesgo y el tipo de ensayo para el que se aplica la acreditaci\u00f3n (por ejemplo, biocompatibilidad, esterilizaci\u00f3n, ensayos f\u00edsicos y mec\u00e1nicos, carga biol\u00f3gica) junto con la norma de referencia.<\/p>\n<p>Estos laboratorios, que son los \u00fanicos autorizados a ensayar productos a efectos de registro, est\u00e1n acreditados ante el Consejo <em>Nacional de Acreditaci\u00f3n de Laboratorios de Ensayo y Calibraci\u00f3n<\/em> (NABL).<\/p>\n<p>Es importante precisar que la solicitud presentada a la CDSCO no es condici\u00f3n suficiente para figurar en la lista, sino que es imprescindible estar tambi\u00e9n acreditado por la NABL. Hasta la fecha, la CDSCO s\u00f3lo ha autorizado <strong>30 laboratorios<\/strong> repartidos por toda la India para ayudar al fabricante a realizar las pruebas de seguridad y la evaluaci\u00f3n de los dispositivos.<\/p>\n<p>La realizaci\u00f3n de pruebas de seguridad y evaluaci\u00f3n precl\u00ednica por laboratorios acreditados (todos ellos con sede en la India) supone una <strong>importante inversi\u00f3n<\/strong> por parte de los fabricantes radicados fuera del pa\u00eds, si se tienen en cuenta los costes derivados de la realizaci\u00f3n de verificaciones reconocidas por la Autoridad Reguladora in situ y la necesidad de enviar muestras representativas al pa\u00eds para su verificaci\u00f3n, con la consiguiente necesidad de gestionar el proceso de importaci\u00f3n.<\/p>\n<h3>&gt;&gt; Con los servicios de <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\"><strong>consultor\u00eda estrat\u00e9gica-regulatoria de Thema<\/strong><\/a>, el apoyo especializado para el <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\"><strong>registro ministerial<\/strong><\/a> y el <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/\"><strong>Representante Local en la India<\/strong><\/a>, Thema puede ayudarle a cumplir los requisitos de la normativa indiana.<\/h3>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/contactanos-2\/\"><strong>P\u00f3ngase en contacto con nosotros<\/strong><\/a><strong>.<\/strong> Estaremos encantados de ayudarle.<\/p>\n<p><strong>Fuentes: <\/strong><\/p>\n<p><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/system\/modules\/CDSCO.WEB\/elements\/download_file_division.jsp?num_id=OTk0Mg==\"><strong>CDSCO<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El pasado 7 de marzo, la Organizaci\u00f3n Central de Control de Normas de Medicamentos (CDSCO) public\u00f3 la Notificaci\u00f3n No.29\/Misc\/03\/2019-DC(211) Lista del  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":27518,"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-27538","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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