{"id":5886,"date":"2017-10-02T14:56:33","date_gmt":"2017-10-02T12:56:33","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=5886\/"},"modified":"2023-01-24T15:05:30","modified_gmt":"2023-01-24T14:05:30","slug":"canada-estas-listo-para-programa-mdsap","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2017\/10\/02\/canada-estas-listo-para-programa-mdsap\/","title":{"rendered":"CANAD\u00c1 \u00bfEst\u00e1s listo para el programa MDSAP?"},"content":{"rendered":"<p>A partir del 1 de enero de 2019 los fabricantes de dispositivos m\u00e9dicos de Clase II, III, IV seg\u00fan el sistema de clasificaci\u00f3n canadiense que desean comercializar sus productos en Canad\u00e1 deber\u00e1n adaptarse al <a href=\"http:\/\/www.thema-med.com\/es\/?s=mdsap\">Programa \u00danico de Auditor\u00edas para Dispositivos M\u00e9dicos (MDSAP)<\/a>.<\/p>\n<p>El MDSAP es un programa de auditor\u00eda \u00fanico que permite a los entes reconocidos por las Organizaciones de Auditor\u00eda conducir una auditor\u00eda \u00fanica para los fabricantes de dispositivos m\u00e9dicos, comprobando el cumplimiento de los requisitos de <a href=\"http:\/\/www.thema-med.com\/es\/?s=gmp\">Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF)<\/a> de todas las Autoridades Regulatorias de los pa\u00edses participantes en el programa.<\/p>\n<p>Adem\u00e1s de Canad\u00e1, los siguientes pa\u00edses forman parte del programa:<\/p>\n<ul>\n<li><a href=\"http:\/\/www.thema-med.com\/es\/registrar-un-dispositivo-medico-en-ee-uu\/\">Estados Unidos de America<\/a>;<\/li>\n<li><a href=\"http:\/\/www.thema-med.com\/es\/registrar-un-dispositivo-medico-en-japon\/\">Jap\u00f3n<\/a>;<\/li>\n<li><a href=\"http:\/\/www.thema-med.com\/es\/registrar-un-dispositivo-medico-en-brasil\/\">Brasil<\/a>;<\/li>\n<li><a href=\"http:\/\/www.thema-med.com\/es\/registrar-un-dispositivo-medico-en-australia\/\">Australia<\/a>.<\/li>\n<\/ul>\n<p><strong>Sin embargo, Canad\u00e1 adoptar\u00e1 el programa MDSAP de antemano, de modo que a partir del 1 de enero de 2019 dejar\u00e1 de aceptar sistemas de calidad que no sean adecuados para el MDSAP.<\/strong><\/p>\n<p>Adem\u00e1s, con vistas a este plazo obligatorio, Health Canada emite desde hace tiempo <a href=\"http:\/\/www.thema-med.com\/es\/registrar-un-dispositivo-medico-en-canada\/\">certificados CMDCAS <\/a>que vencen el 31 de diciembre de 2018, independientemente de la fecha de emisi\u00f3n, ya que todos los certificados CMDCAS ya no ser\u00e1n v\u00e1lidos despu\u00e9s de esa fecha.<\/p>\n<p>\u00bfC\u00f3mo deber\u00eda actuar un fabricante que empieza a comercializar un dispositivo de Clase II, III o IV en Canad\u00e1?<\/p>\n<p>El certificado del sistema de calidad es un requisito previo para presentar una pr\u00e1ctica de Licencia de Dispositivo M\u00e9dico (MDL) a Health Canada y las cosas cambian si el fabricante ya tiene un sistema de calidad certificado seg\u00fan los requisito de Canad\u00e1 (CMDCAS) o aspira a obtener una certificaci\u00f3n.<\/p>\n<p>Entre las empresas ya certificadas, aquellas con un certificado que vence el 31\/12\/2018 tienen tiempo para adaptarse al programa MDSAP; mientras que aquellas con un certificado v\u00e1lido hasta 2017 deben considerar que Health Canada anunci\u00f3 recientemente que ya no aceptar\u00e1 los certificados CMDCAS a partir del 1 de enero de 2018.<\/p>\n<p>Por lo tanto, estas \u00faltimas tienen que adaptarse al programa MDSAP lo antes posible y obtener un certificado de sistema conforme. Lo mismo ocurre con quien se acerca al mercado canadiense por primera vez y a\u00fan no ha obtenido una certificaci\u00f3n del sistema para Canad\u00e1.<\/p>\n<p>\u00bfEntonces? \u00bfEst\u00e1s listo para el programa MDSAP? \u00a1No te dejes coger desprevenido!<\/p>\n<p><strong><em><img decoding=\"async\" class=\"wp-image-10 alignnone\" src=\"https:\/\/publicationsthema.files.wordpress.com\/2012\/08\/thema-logo-trasparente_small.png\" alt=\"THEMA - Logo TRASPARENTE_small\" width=\"70\" height=\"69\" \/>Silvia Scarpellini<\/em><\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>\u00bfNecesitas m\u00e1s informaci\u00f3n sobre Canad\u00e1? <a href=\"http:\/\/www.thema-med.com\/es\/?s=canad%C3%A0\">Pulsa aqu\u00ed<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A partir del 1 de enero de 2019 los fabricantes de dispositivos m\u00e9dicos de Clase II, III, IV seg\u00fan el sistema  [&#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":[680,3],"tags":[],"class_list":["post-5886","post","type-post","status-publish","format-standard","hentry","category-blog-es","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CANAD\u00c1 \u00bfEst\u00e1s listo para el programa MDSAP? 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