{"id":7094,"date":"2018-05-09T10:24:17","date_gmt":"2018-05-09T08:24:17","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=7094"},"modified":"2023-06-15T14:48:30","modified_gmt":"2023-06-15T12:48:30","slug":"local-representative-and-license-holder","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/","title":{"rendered":"Local Representative"},"content":{"rendered":"<div style=\"float: left; width: 70%;\">\n<p><img decoding=\"async\" class=\"size-medium wp-image-10372\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/09\/local-representative--300x200.jpg\" alt=\"\" width=\"300\" height=\"200\" \/><\/p>\n<p><strong>We take your company around the world <\/strong><\/p>\n<p>In order to access to foreign markets of medical devices, it is often necessary to designate a <em>Local Representative: <\/em>local authorised representative responsible for registration and relations with the Regulatory Authorities of the reference Country and for post-market activities.<\/p>\n<p>Through this service, we ensure you full control of your registrations making you independent of your distributors.<\/p>\n<p>Where required, in complementarity with the Local Representative, we also offer the License Holder service.<\/p>\n<p><strong>Below there are some service applications:<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/www.thema-med.com\/en\/marketing-of-a-medical-device-in-europe\/\"><strong>Europe <\/strong><\/a>(<strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/european-authorised-representative-service\/\">European Authorised Representative \/ Single Authorised Representative for Europe \u2013 EU REP<\/a><\/strong>).<\/li>\n<li><strong><a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-switzerland\/\">Switzerland<\/a><\/strong> (<strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/swiss-authorised-representative-service\/\">Swiss Authorised Representative<\/a><\/strong>).<\/li>\n<li><a href=\"https:\/\/www.thema-med.com\/en\/registration-medical-device-united-kingdom\/\"><strong>United Kingdom<\/strong><\/a>\u00a0(<a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/uk-responsible-person-service\/\"><strong>UK\u00a0Responsible Person<\/strong><\/a>).<\/li>\n<li><a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-in-the-u-s-a\/\"><strong>U.S.A. <\/strong><\/a>(<a href=\"https:\/\/www.thema-med.com\/en\/us-agent\/\"><strong>US Agent<\/strong>,<\/a> Official Correspondent, Contact Person, <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/us-initial-importer-service\/\"><strong>US Initial Importer<\/strong><\/a>,\u00a0<a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/us-electronic-medical-device-reporting-service\/\"><strong>US\u00a0Electronic Medical Device Reporting<\/strong><\/a>).<u><\/u><\/li>\n<li><a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-in-canada\/\"><strong>Canada<\/strong><\/a>\u00a0(Canadian Regulatory Correspondent).<\/li>\n<li><strong><a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-in-australia\/\">Australia<\/a>\u00a0<\/strong>(Sponsor).<\/li>\n<li><a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-in-brazil\/\"><strong>Brazil <\/strong><\/a>(Brazilian Registration Holder \u2013 BRH).<\/li>\n<li><strong><a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-japan\/\">Japan<\/a> <\/strong>(Marketing Authorization Holder \u2013 MAH e Designated Marketing Authorization Holder \u2013 DMAH).<\/li>\n<li><a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-south-korea\/\"><strong>South Korea <\/strong><\/a>(Korean Licence Holder \u2013 KLH).<\/li>\n<li><a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-in-mexico\/\"><strong>Mexico <\/strong><\/a>(Mexican Registration Holder \u2013 MRH).<\/li>\n<li><a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-china\/\"><strong>China <\/strong><\/a>(Legal Agent).<\/li>\n<li><a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-russia\/\"><strong>Russia and CIS countries <\/strong><\/a>(Local Representative).<\/li>\n<li><strong><a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-argentina\/\">Argentina<\/a>\u00a0<\/strong>(Local Authorised Representative \u2013 AAR).<\/li>\n<li><strong><a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-india\/\">India<\/a>\u00a0<\/strong>(Indian Authorized Representative \u2013 IAR).<\/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;\">\n<p><a href=\"https:\/\/www.thema-med.com\/en\/services\/ivdr-emergency-kit\/\">IVDR Emergency Kit<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/services\/new-mdr-emergency-kit\/\">MDR Emergency Kit<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">Strategic Regulatory Consulting<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/\">CE Certification Support<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/en\/services\/italian-and-european-ministerial-registrations\/\">Italian and European Ministerial Registrations<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/en\/services\/international-registrations-outside-the-eu\/\">International Registrations outside the EU<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/en\/services\/local-representative\/\">Local Representative\u00a0<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/en\/services\/quality-and-international-gmps\/\">Quality and International GMPs<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>We take your company around the world In order to access to foreign markets of medical devices, it is often necessary  [&#8230;]<\/p>\n","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-7094","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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