As of December, the procedure for registration, re-registration and major changes in the sanitary registry will be subject to change, specifically in the case of medical devices, with which article 28 of Supreme Decree N\u00b0 016-2011-SA is modified.<\/p>\n
Thus, through the Directorate of Medical Devices and Medical Devices, the DIGEMID authorities announced that the presentation of a translated version of the clinical data and their respective conclusions, which will accompany both the risk management report, according to the specific ISO standard in force, as well as the Clinical Evaluation Report, is fully authorized.<\/p>\n
In case you need further information or advice on the subject, OMC Pharma Medic is at your disposal. Write to us at: omago@omcpharmamedic.com<\/a> or porladini@omcpharmamedic.com<\/a><\/p>","protected":false},"excerpt":{"rendered":" A partir del mes de diciembre, ser\u00e1 sujeto de cambio el tr\u00e1mite que se realiza para la inscripci\u00f3n, reinscripci\u00f3n y cambios de importancia mayor en el registro sanitario, espec\u00edficamente en el caso de los dispositivos m\u00e9dicos, con lo cual queda modificado el art\u00edculo 28 del Decreto Supremo N\u00b0 016-2011-SA. Es as\u00ed como a trav\u00e9s de […]<\/p>","protected":false},"author":2,"featured_media":18735,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[145,188,191,190,189],"class_list":["post-18733","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-digemid","tag-dispositovos-medicos","tag-importacion","tag-inscripcion","tag-productos-sanitarios"],"_links":{"self":[{"href":"https:\/\/omcpharmamedic.com\/en\/wp-json\/wp\/v2\/posts\/18733","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/omcpharmamedic.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/omcpharmamedic.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/omcpharmamedic.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/omcpharmamedic.com\/en\/wp-json\/wp\/v2\/comments?post=18733"}],"version-history":[{"count":1,"href":"https:\/\/omcpharmamedic.com\/en\/wp-json\/wp\/v2\/posts\/18733\/revisions"}],"predecessor-version":[{"id":18736,"href":"https:\/\/omcpharmamedic.com\/en\/wp-json\/wp\/v2\/posts\/18733\/revisions\/18736"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/omcpharmamedic.com\/en\/wp-json\/wp\/v2\/media\/18735"}],"wp:attachment":[{"href":"https:\/\/omcpharmamedic.com\/en\/wp-json\/wp\/v2\/media?parent=18733"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/omcpharmamedic.com\/en\/wp-json\/wp\/v2\/categories?post=18733"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/omcpharmamedic.com\/en\/wp-json\/wp\/v2\/tags?post=18733"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}