{"id":6893,"date":"2021-11-05T12:11:04","date_gmt":"2021-11-05T11:11:04","guid":{"rendered":"https:\/\/productosanitario.es\/import-of-medical-devices\/"},"modified":"2025-03-06T15:38:35","modified_gmt":"2025-03-06T14:38:35","slug":"import-of-medical-devices","status":"publish","type":"page","link":"https:\/\/productosanitario.es\/en\/import-of-medical-devices\/","title":{"rendered":"Import of medical devices"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"6893\" class=\"elementor elementor-6893 elementor-4498\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6d6797d e-flex e-con-boxed e-con e-parent\" data-id=\"6d6797d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7345282 elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-heading\" data-id=\"7345282\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Import of <b>medical devices<\/b><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-342890e e-flex e-con-boxed e-con e-parent\" data-id=\"342890e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e3e31fc elementor-widget__width-inherit elementor-widget-tablet__width-inherit elementor-widget elementor-widget-heading\" data-id=\"e3e31fc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">We understand an importer of a medical device to be any natural or legal person established in the European Union. It places a product from a third country on the Union market. \n\nAs the main requirement, it is mandatory to have a prior license as an importer of a medical device, granted by the AEMPS.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-22891a6 e-con-full e-flex e-con e-parent\" data-id=\"22891a6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-030537a e-con-full e-flex e-con e-child\" data-id=\"030537a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-49aa92d elementor-widget elementor-widget-text-editor\" data-id=\"49aa92d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>PS Consulting<\/strong> has<a href=\"https:\/\/productosanitario.es\/importar-producto-sanitario-2\/\" target=\"_blank\" rel=\"noopener\"> its own license for the import<\/a> of <a href=\"https:\/\/productosanitario.es\/category\/producto-sanitario\/\" target=\"_blank\" rel=\"noopener\">medical devices<\/a>. If you are thinking of importing any type of product from a country outside the European Union, contact us and we will carry out the import procedures; while we will manage your own license. <\/p><p>It should be remembered that in addition to the importer&#8217;s license, you will have to have at least one person responsible for compliance with the regulations (<a href=\"https:\/\/productosanitario.es\/category\/eudamed\/prrc\/\" target=\"_blank\" rel=\"noopener\">PRRC)<\/a> in your company according to the <a href=\"https:\/\/productosanitario.es\/category\/mdr-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\">MDR<\/a> regulation; or a technical manager as stated in <a href=\"https:\/\/productosanitario.es\/category\/rd-192-2023-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\"><strong>Royal Decree 192\/2023<\/strong><\/a> of 21 March, which regulates medical devices, a service that we can also offer you.<\/p><p>Whenever a <a href=\"https:\/\/productosanitario.es\/en\/\">medical device<\/a> is imported, a number of requirements shall be taken into account to ensure that devices complying with the <a href=\"https:\/\/productosanitario.es\/category\/mdr-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\">MDR Regulation 2017\/745<\/a> are placed on the Union market.<\/p><p><strong>PS Consulting<\/strong>, as an importer of medical devices, will check:<\/p><ul><li>the product is <a href=\"https:\/\/productosanitario.es\/category\/marcado-ce-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\">CE marked<\/a> and the <a href=\"https:\/\/productosanitario.es\/declaracion-ue-de-conformidad-de-producto-sanitario-2\/\">EU declaration of conformity<\/a> for the product has been drawn up;<\/li><li>the manufacturer is identified and has appointed an <a href=\"https:\/\/productosanitario.es\/representante-autorizado-o-authorised-representative\/\" target=\"_blank\" rel=\"noopener\">authorized representative<\/a>;<\/li><li>the product is labelled in accordance with the Regulation and accompanied by the necessary <a href=\"https:\/\/productosanitario.es\/category\/documentacion-entregada-por-el-fabricante\/ifu-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\">instructions for use<\/a> ;<\/li><li>Where applicable, the manufacturer has assigned the product a<a href=\"https:\/\/productosanitario.es\/category\/eudamed\/udi-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\"> unique identifier<\/a>.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-29b618c e-con-full e-flex e-con e-child\" data-id=\"29b618c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-cd6cf1b e-flex e-con-boxed e-con e-parent\" data-id=\"cd6cf1b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-bb2f115 e-con-full e-flex e-con e-child\" data-id=\"bb2f115\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-94b9f64 elementor-widget elementor-widget-heading\" data-id=\"94b9f64\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Labelling of the importer of medical devices<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c06761d elementor-widget elementor-widget-text-editor\" data-id=\"c06761d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The importer shall indicate on the product or its packaging or in a document accompanying the product its name, registered trade name or registered trademark, its registered office and the address at which they can be contacted and which allows them to be located. They shall ensure that the label information provided by the manufacturer is not obscured by other labels. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9f7e1d0 e-flex e-con-boxed e-con e-parent\" data-id=\"9f7e1d0\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6242ac7 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-widget elementor-widget-heading\" data-id=\"6242ac7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">If you need to import a medical device, call us and we will find the best option that suits your needs.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b4e2140 e-flex e-con-boxed e-con e-parent\" data-id=\"b4e2140\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c6b5cc7 elementor-widget elementor-widget-heading\" data-id=\"c6b5cc7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Blog<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d59c7f4 elementor-grid-tablet-3 elementor-widget__width-inherit elementor-grid-3 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"d59c7f4\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;template_id&quot;:6945,&quot;columns_tablet&quot;:3,&quot;row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:20,&quot;sizes&quot;:[]},&quot;_skin&quot;:&quot;post&quot;,&quot;columns&quot;:&quot;3&quot;,&quot;columns_mobile&quot;:&quot;1&quot;,&quot;edit_handle_selector&quot;:&quot;[data-elementor-type=\\&quot;loop-item\\&quot;]&quot;,&quot;row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"loop-grid.post\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-loop-nothing-found-message\">\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Import of medical devices We understand an importer of a medical device to be any natural or legal person established in the European Union. It places a product from a third country on the Union market. As the main requirement, it is mandatory to have a prior license as an importer of a medical device, [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-6893","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Import of medical devices - Consultor\u00eda de producto sanitario<\/title>\n<meta name=\"description\" content=\"The importation of a medical device consists of placing products on the Union market manufactured by companies outside the Union\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/productosanitario.es\/en\/import-of-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Import of medical devices - 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