{"id":20543,"date":"2022-03-29T09:37:05","date_gmt":"2022-03-29T07:37:05","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=20543"},"modified":"2022-03-29T09:37:05","modified_gmt":"2022-03-29T07:37:05","slug":"japon-informe-mdsap-ok-a-partir-1-abril-2022","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2022\/03\/29\/japon-informe-mdsap-ok-a-partir-1-abril-2022\/","title":{"rendered":"JAP\u00d3N: informe MDSAP OK a partir del 1 de abril de 2022"},"content":{"rendered":"\n<p>El <strong>Ministerio japones de Salud, Trabajo y Bienestar (MHLW)<\/strong> ha actualizado sus procedimientos para <strong>aceptar oficialmente los informes del MDSAP a partir del 1 de abril de 2022,<\/strong> pruebas del cumplimiento del sistema de gesti\u00f3n de la calidad necesario para los procedimientos de registro de los productos sanitarios.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/03\/giappone-ok-report-mdsap-1-aprile-2022-e1648539127927-1024x536.jpg\" alt=\"JAP\u00d3N Informe MDSAP OK a partir del 1 de abril de 2022\" class=\"wp-image-20482\"\/><figcaption>Informe MDSAP OK a partir del 1 de abril de 2022<\/figcaption><\/figure>\n\n\n\n<p>Se recuerda que <strong>Programa de Auditor\u00eda \u00danica de Dispositivos M\u00e9dicos\n(MDSAP)<\/strong> es un programa que permite a los organismos acreditados por las\nautoridades reguladoras de los pa\u00edses participantes (Estados Unidos, Canad\u00e1,\nAustralia, Brasil y Jap\u00f3n) realizar una <strong>\u00fanica auditor\u00eda<\/strong> para verificar\nque los fabricantes de productos sanitarios cumplen los requisitos de gesti\u00f3n\ndel sistema de calidad de los pa\u00edses correspondientes.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u00bfQu\u00e9 cambiar\u00e1 a partir del 1 de abril de 2022 en Jap\u00f3n?<\/strong><\/h2>\n\n\n\n<p>Anteriormente, la Autoridad Reguladora japonesa realizaba un control\ndocumental y una auditor\u00eda en la empresa antes de obtener el certificado de\nregistro del producto sanitario.<\/p>\n\n\n\n<p>A partir del 1 de abril de 2022, con la aceptaci\u00f3n oficial de los informes\ndel MDSAP, el proceso se simplificar\u00e1, ya que la Autoridad Reguladora solo\ntendr\u00e1 que realizar una revisi\u00f3n de documentos.<\/p>\n\n\n\n<p>Sin embargo, <strong>no todos los productos sanitarios<\/strong> pueden beneficiarse\nde este procedimiento simplificado. Hay una serie de productos que siguen\nexcluidos, como los productos que contienen tejidos animales, los dispositivos\nIVD radiactivos y todos los establecimientos que reprocesan dispositivos de un\nsolo uso.<\/p>\n\n\n\n<p>Hay que tener en cuenta que para utilizar el informe MDSAP en Jap\u00f3n hay que\npagar una <strong>tasa adicional<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u00bfQu\u00e9 hacer una vez implantado el MDSAP?<\/strong><\/h2>\n\n\n\n<p>Es aconsejable <strong>estar al tanto<\/strong>\nde los cambios que puedan producirse en los pa\u00edses del MDSAP. Por ello, le recomendamos\nque siga los <strong>requisitos normativos de los pa\u00edses de referencia del MDSAP<\/strong>\na trav\u00e9s de las p\u00e1ginas web de las Autoridades Reguladoras y de los boletines\ndel sector para estar siempre actualizado desde el punto de vista normativo.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u00bfSab\u00eda que Thema puede ayudarle a implantar y adaptar su sistema de gesti\u00f3n de la calidad a los requisitos del MDSAP?<\/strong><\/h2>\n\n\n\n<p>Gracias a sus muchos a\u00f1os de experiencia en este campo, nuestros consultores pueden ayudarle a <strong><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/callida-y-bpf-internacionales\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"implantar el sistema de calidad (si apre in una nuova scheda)\">implantar el sistema de calidad<\/a><\/strong> para productos sanitarios, de acuerdo con los requisitos establecidos en la normativa del pa\u00eds correspondiente.<\/p>\n\n\n\n<p><strong><a href=\"mailto:sales@thema-med.com\">P\u00f3ngase en contacto con nosotros<\/a><\/strong> para obtener m\u00e1s informaci\u00f3n y <strong><a href=\"https:\/\/www.thema-med.com\/es\/newsletter\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"suscr\u00edbase a nuestro bolet\u00edn (si apre in una nuova scheda)\">suscr\u00edbase a nuestro bolet\u00edn<\/a><\/strong>.<\/p>\n\n\n\n<p><em>Fuente:<\/em><\/p>\n\n\n\n<p><a href=\"https:\/\/www.mhlw.go.jp\/hourei\/doc\/tsuchi\/T211001I0010.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Aceptaci\u00f3n de los informes MDSAP, MHLW, en vigor desde el 1 de abril de 2022 (si apre in una nuova scheda)\">Aceptaci\u00f3n de los informes MDSAP, MHLW, en vigor desde el 1 de abril de 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El Ministerio japones de Salud, Trabajo y Bienestar (MHLW) ha actualizado sus procedimientos para aceptar oficialmente los informes del MDSAP a  [&#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],"tags":[],"class_list":["post-20543","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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