{"id":24623,"date":"2022-11-22T10:23:06","date_gmt":"2022-11-22T09:23:06","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=24623"},"modified":"2022-11-22T14:24:30","modified_gmt":"2022-11-22T13:24:30","slug":"china-no-mas-certificados-de-registro-en-papel","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2022\/11\/22\/china-no-mas-certificados-de-registro-en-papel\/","title":{"rendered":"CHINA: no m\u00e1s certificados de registro en papel"},"content":{"rendered":"<h2>El pasado 26 de octubre, el <em>Center for Medical Device Evaluation<\/em> (CMDE) de la <a href=\"http:\/\/english.nmpa.gov.cn\/index.html\">NMPA (<em>National Medical Products Administration<\/em>)<\/a> emiti\u00f3 el <a href=\"https:\/\/www.nmpa.gov.cn\/xxgk\/ggtg\/qtggtg\/20221026155043182.html\"><em>Notice of Electronic Registration Certificate<\/em><\/a>, un aviso que anuncia la implementaci\u00f3n del sistema de emisi\u00f3n de <strong>certificados de registro electr\u00f3nico<\/strong>, en lugar de papel, para los Dispositivos M\u00e9dicos aprobados <strong>a partir del 1 de noviembre de 2022<\/strong>.<\/h2>\n<p>Inicialmente, el registro electr\u00f3nico s\u00f3lo es posible para las licencias nuevas o modificadas de los Dispositivos M\u00e9dicos de clase III fabricados en el pa\u00eds y los Dispositivos M\u00e9dicos de clase II y III importados en China.<\/p>\n<p>El <em>Notice of Electronic Registration Certificate<\/em> tambi\u00e9n aclara que el certificado electr\u00f3nico tiene <strong>el mismo efecto legal<\/strong> que el certificado en papel y s\u00f3lo se emite tras la autentificaci\u00f3n del nombre real del Fabricante.<\/p>\n<p>Se trata de un cambio significativo con respecto a las disposiciones anteriores de la NMPA, pero tambi\u00e9n de <strong>un gran paso adelante para los Fabricantes extranjeros<\/strong>, que a menudo no se dan cuenta de la importancia de conservar la copia original del certificado en papel para demostrar la exactitud de la informaci\u00f3n de registro de los cambios realizados.<\/p>\n<p>De hecho, anteriormente, cada vez que se realizaba un cambio, se requer\u00eda una copia f\u00edsica en papel, por lo que perderla o no tenerla pod\u00eda crear problemas durante, por ejemplo, la fase de renovaci\u00f3n o modificaci\u00f3n. Ahora, con la exigencia de un certificado digital como el <strong><em>Certification Authority certificate <\/em>(CA certificate)<\/strong>, la gesti\u00f3n del ciclo del producto, desde la presentaci\u00f3n hasta la postcomercializaci\u00f3n, <strong>se gestiona de forma<\/strong> <strong>centralizada y electr\u00f3nica por la NMPA<\/strong>.<\/p>\n<p><strong>&gt;&gt; \u00bfNecesita ayuda para comercializar sus dispositivos en China?<\/strong><\/p>\n<p>Conf\u00ede en los expertos de Thema para obtener una <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\"><strong>consulencia estrat\u00e9gico-regulatoria<\/strong><\/a> y servicios de <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\"><strong>registros internacionales extra-UE<\/strong><\/a>. Gracias al desarrollo profesional constante, los profesionales de Thema le permitir\u00e1n acceder al mercado chino de forma m\u00e1s r\u00e1pida y competitiva.<\/p>\n<h3><strong>&gt;&gt;&gt; \u00bfQuiere ser independiente de su distribuidor chino? <\/strong><\/h3>\n<p>Elija a Thema como su <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/servicio-representante-autorizado-europeo\/\"><strong>Representante Local<\/strong><\/a> (Agente Legal y de Servicios) y ser\u00e1 independiente en el proceso de regulaci\u00f3n: no tendr\u00e1 que temer obst\u00e1culos a la comercializaci\u00f3n de sus dispositivos en caso de que se rompa la relaci\u00f3n con su Distribuidor, y sus oportunidades de business aumentar\u00e1n si quiere involucrar a otros partners de ventas para un territorio tan amplio.<\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/contactanos-2\/\"><strong>P\u00f3ngase en contacto con nosotros<\/strong><\/a> para m\u00e1s informaci\u00f3n.<\/p>\n<p>Fuente: <a href=\"https:\/\/www.nmpa.gov.cn\/xxgk\/ggtg\/qtggtg\/20221026155043182.html\">https:\/\/www.nmpa.gov.cn\/xxgk\/ggtg\/qtggtg\/20221026155043182.html<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El pasado 26 de octubre, el Center for Medical Device Evaluation (CMDE) de la NMPA (National Medical Products Administration) emiti\u00f3 el  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":24604,"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-24623","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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