{"id":7091,"date":"2018-05-09T10:21:35","date_gmt":"2018-05-09T08:21:35","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=7091"},"modified":"2023-06-26T08:39:31","modified_gmt":"2023-06-26T06:39:31","slug":"international-registrations-outside-the-eu","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/services\/international-registrations-outside-the-eu\/","title":{"rendered":"INTERNATIONAL REGISTRATIONS OUTSIDE THE EU"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><div style=\"float: left; width: 70%;\"><img decoding=\"async\" class=\"wp-image-7061 size-full alignnone\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2017\/07\/GMP.jpg\" alt=\"\" width=\"259\" height=\"194\"> <strong>Towards international markets <\/strong> Thanks to our network of partner Agencies in more than 20 extra-European Countries, we carry out preparation and support activities for the registration of medical devices and in vitro diagnostic medical devices at the foreign Regulatory Authorities. <strong>Some services:<\/strong><\/p>\n<ul>\n<li>Feasibility analysis for placing on the market in the target country.<\/li>\n<li>Identification of pre- and post-market regulatory requirements.<\/li>\n<li><em>Pre-screening <\/em>of the documentation for the adaptation to international regulation.<\/li>\n<li><em>Dossier <\/em>preparation\/registration practices (510(k), MDAL, STED, ASEAN CSDT, dossier, ecc\u2026).<\/li>\n<li>Post-practical submission monitoring.<\/li>\n<li><a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/\"><strong><em>Licence holding <\/em><\/strong><strong>e Local Representative service. <\/strong><\/a><\/li>\n<li>Support in the management of correspondence between the company and the Regulatory Authority of the reference country.<\/li>\n<li>Regular renewals.<\/li>\n<\/ul>\n<\/div>\n<div id=\"serviceslist\" style=\"float: left; width: 27%; margin-left: 1.5%; padding-left: 1.5%; border-left: 1px solid;\"><a href=\"https:\/\/www.thema-med.com\/en\/services\/ivdr-emergency-kit\/\">IVDR Emergency Kit<\/a> <a href=\"https:\/\/www.thema-med.com\/en\/services\/new-mdr-emergency-kit\/\">MDR Emergency Kit<\/a> <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">Strategic Regulatory Consulting<\/a> <a href=\"https:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/\">CE Certification Support<\/a> <a href=\"https:\/\/www.thema-med.com\/en\/services\/italian-and-european-ministerial-registrations\/\">Italian and European Ministerial Registrations<\/a> <a href=\"https:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/new-mdr-emergency-kit-economic-operators-medical-devices\/\">International Registrations outside the EU<\/a> <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative\/\">Local Representative <\/a> <a href=\"https:\/\/www.thema-med.com\/en\/services\/quality-and-international-gmps\/\">Quality and International GMPs<\/a><\/div>\n<div style=\"float: none; clear: both;\"> <\/div>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":10312,"parent":9970,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-7091","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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