{"id":6994,"date":"2018-04-20T11:20:31","date_gmt":"2018-04-20T09:20:31","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=6994"},"modified":"2023-01-24T15:05:24","modified_gmt":"2023-01-24T14:05:24","slug":"canada-esta-punto-de-finalizar-el-periodo-de-transicion-la-certificacion-mdsap","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2018\/04\/20\/canada-esta-punto-de-finalizar-el-periodo-de-transicion-la-certificacion-mdsap\/","title":{"rendered":"CANAD\u00c1: est\u00e1 a punto de finalizar el periodo de transici\u00f3n a MDSAP"},"content":{"rendered":"<p>A partir del 1 de enero de 2019, el certificado MDSAP ser\u00e1 obligatorio para vender <span class=\"st\">dispositivos m\u00e9dicos <\/span>(DM) e dispositivos m\u00e9dicos de diagn\u00f3stico in vitro IVD en Canad\u00e1.<\/p>\n<p>Health Canada, consciente del largo proceso de emisi\u00f3n del certificado, ha anunciado que no sancionar\u00e1 a aquellos fabricantes que demuestren haber estado sujetos a una auditor\u00eda completa en 2018, sin haber recibido todav\u00eda el certificado correspondiente.<\/p>\n<p>Los fabricantes que todav\u00eda estaban retrasados \u200b\u200by que se sometieron a una auditor\u00eda de re-certificaci\u00f3n para la norma CAN\/CSA ISO 13485\/CMDCAS desde el 1 de enero de 2016, ahora podr\u00e1n pasar al MDSAP durante la auditor\u00eda de vigilancia, lo que les permitir\u00e1 mantener v\u00e1lidos los procesos de certificaci\u00f3n ya incurridos y luego seguir vendiendo sus productos hasta que se obtenga el certificado MDSAP.<\/p>\n<p>Tambi\u00e9n se recuerda que a partir del 1 de marzo de 2019, la norma CAN\/CSA ISO 13485:2016 reemplazar\u00e1 definitivamente, despu\u00e9s de un periodo de transici\u00f3n de 3 a\u00f1os, a la versi\u00f3n anterior de 2003.<\/p>\n<p>Para m\u00e1s informaci\u00f3n:<\/p>\n<p><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/quality-systems-13485\/notice-transition-revised-version-13485-impact-compliance-quality-management-system-requirements-canadian-medical-devices-regulations.html\">https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/quality-systems-13485\/notice-transition-revised-version-13485-impact-compliance-quality-management-system-requirements-canadian-medical-devices-regulations.html<\/a><\/p>\n<p><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/activities\/international\/transition-medical-device-single-audit-program\/certification-cycle-notice.html\">https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/activities\/international\/transition-medical-device-single-audit-program\/certification-cycle-notice.html<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A partir del 1 de enero de 2019, el certificado MDSAP ser\u00e1 obligatorio para vender dispositivos m\u00e9dicos (DM) e dispositivos m\u00e9dicos  [&#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-6994","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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