{"id":3085,"date":"2025-06-05T08:41:54","date_gmt":"2025-06-05T08:41:54","guid":{"rendered":"https:\/\/medical-hub.info\/?page_id=3085"},"modified":"2026-02-23T08:57:06","modified_gmt":"2026-02-23T08:57:06","slug":"upovnovazhenyj-predstavnyk","status":"publish","type":"page","link":"https:\/\/medical-hub.info\/en\/services\/representative-services-in-ukraine\/authorized-representative\/","title":{"rendered":"Authorized representative"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"3085\" class=\"elementor elementor-3085\" data-elementor-post-type=\"page\">\n\t\t\t\t<section class=\"elementor-element elementor-element-83bf142 cst-trustee-hero e-flex e-con-boxed e-con e-parent\" data-id=\"83bf142\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f0f93be e-con-full e-flex e-con e-child\" data-id=\"f0f93be\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-5c56525 e-con-full cst-breadcrums-box e-flex e-con e-child\" data-id=\"5c56525\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e886aa8 elementor-widget-mobile__width-initial cst-scroll-breadcrmbs-btn js-cst-scroll-breadcrmbs-btn elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-button\" data-id=\"e886aa8\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/en\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M4 12H20M4 12L10 6M4 12L10 18\" stroke=\"#141A2A\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-625547a cst-breadcrumbs js-cst-breadcrumbs elementor-widget-mobile__width-initial elementor-widget elementor-widget-hfe-breadcrumbs-widget\" data-id=\"625547a\" data-element_type=\"widget\" data-widget_type=\"hfe-breadcrumbs-widget.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<nav aria-label=\"Breadcrumb\"><ul class=\"hfe-breadcrumbs hfe-breadcrumbs-show-home\"><li class=\"hfe-breadcrumbs-item hfe-breadcrumbs-first\"><span class=\"hfe-breadcrumbs-home-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M20 18.1833V10.9C20 10.153 19.6839 9.43656 19.1213 8.90834L13.4142 3.54999C12.6332 2.81667 11.3668 2.81667 10.5858 3.54999L4.87868 8.90834C4.31607 9.43656 4 10.153 4 10.9V18.1833C4 19.7389 5.34315 21 7 21H9V17C9 15.8954 9.89543 15 11 15H13C14.1046 15 15 15.8954 15 17V21H17C18.6569 21 20 19.7389 20 18.1833Z\" stroke=\"#141A2A\" stroke-width=\"2\" stroke-linejoin=\"round\"><\/path><\/svg><\/span><a href=\"https:\/\/medical-hub.info\/en\"><span class=\"hfe-breadcrumbs-text\"><\/span><\/a><\/li><\/ul><\/nav>\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-759d25f e-con-full e-flex e-con e-child\" data-id=\"759d25f\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-842c8f2 e-con-full e-flex e-con e-child\" data-id=\"842c8f2\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-968ea0c cst-hero-title elementor-widget-tablet__width-initial elementor-widget elementor-widget-heading\" data-id=\"968ea0c\" data-element_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\"><span class=\"cst-color-text\">Authorized representative<\/span> for medical devices in Ukraine<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c1dd81a elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"c1dd81a\" data-element_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\">The first step for a foreign manufacturer of medical devices planning to enter the Ukrainian market is to appoint an authorized representative. This person or company, registered in Ukraine, acts as an official intermediary between the manufacturer and local regulatory authorities<\/p>\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-1205c44 e-con-full e-flex e-con e-child\" data-id=\"1205c44\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-a36e857 e-con-full e-flex e-con e-child\" data-id=\"a36e857\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-8745fb7 e-con-full e-flex e-con e-child\" data-id=\"8745fb7\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a15f2f9 e-transform elementor-widget elementor-widget-html\" data-id=\"a15f2f9\" data-element_type=\"widget\" data-settings=\"{&quot;_transform_translateY_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:3,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<svg width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\r\n  <path d=\"M7.5 12.5L10.5 15.5L16.5 9.5M12 22C6.47715 22 2 17.5228 2 12C2 6.47715 6.47715 2 12 2C17.5228 2 22 6.47715 22 12C22 17.5228 17.5228 22 12 22Z\" stroke=\"#54E1CD\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" \/>\r\n<\/svg>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-16b1230 elementor-widget elementor-widget-heading\" data-id=\"16b1230\" data-element_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\">Why is this important?<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-64b0176 elementor-widget elementor-widget-heading\" data-id=\"64b0176\" data-element_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\">The choice of an authorized representative is critical to ensuring that products comply with all requirements of Ukrainian legislation.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\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<\/section>\n\t\t<section class=\"elementor-element elementor-element-785bab4 e-flex e-con-boxed e-con e-parent\" data-id=\"785bab4\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-1878a14 e-con-full e-flex e-con e-child\" data-id=\"1878a14\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<section class=\"elementor-element elementor-element-e7e956f e-con-full e-flex e-con e-child\" data-id=\"e7e956f\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-0ea3167 e-con-full cst-role-and-respon-box e-flex e-con e-child\" data-id=\"0ea3167\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f651b71 elementor-widget__width-initial cst-title elementor-widget elementor-widget-heading\" data-id=\"f651b71\" data-element_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\">Role and <span class=\"cst-color-text\">responsibilities<\/span> of an authorized representative agreement<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0147431 elementor-widget elementor-widget-shortcode\" data-id=\"0147431\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\">    <ul class=\"cst-services-list cst-reset-list\">\r\n                    <li class=\"cst-item\">\r\n                <div class=\"cst-box\">\r\n                    <p class=\"cst-service-name\">Legal responsibility<\/p>\r\n\r\n                    <p class=\"cst-service-decs\">\r\n                        The authorized representative acts on behalf of the manufacturer, ensuring that the products comply with Ukrainian regulations. He is also responsible for compliance with all legal requirements governing the circulation of medical devices                    <\/p>\r\n                <\/div>\r\n            <\/li>\r\n                    <li class=\"cst-item\">\r\n                <div class=\"cst-box\">\r\n                    <p class=\"cst-service-name\">Post-market surveillance<\/p>\r\n\r\n                    <p class=\"cst-service-decs\">\r\n                        The authorized representative monitors the safety and performance of products after they have been placed on the market. This includes collecting and analyzing data on possible side effects or incidents related to the use of the product                    <\/p>\r\n                <\/div>\r\n            <\/li>\r\n                    <li class=\"cst-item\">\r\n                <div class=\"cst-box\">\r\n                    <p class=\"cst-service-name\">Documentation<\/p>\r\n\r\n                    <p class=\"cst-service-decs\">\r\n                        The Authorized Representative keeps and maintains all necessary technical documentation, ensuring its availability for review by regulatory authorities. This includes certificates, test reports, and declarations of conformity                    <\/p>\r\n                <\/div>\r\n            <\/li>\r\n                    <li class=\"cst-item\">\r\n                <div class=\"cst-box\">\r\n                    <p class=\"cst-service-name\">Communication with government authorities<\/p>\r\n\r\n                    <p class=\"cst-service-decs\">\r\n                        The authorized representative acts as the key contact person between the manufacturer and government authorities, such as the State Service of Ukraine on Medicinal Products. He is responsible for the timely submission of reports and responses to inquiries regarding the product                    <\/p>\r\n                <\/div>\r\n            <\/li>\r\n                    <li class=\"cst-item\">\r\n                <div class=\"cst-box\">\r\n                    <p class=\"cst-service-name\">Legal information<\/p>\r\n\r\n                    <p class=\"cst-service-decs\">\r\n                        In accordance with legal requirements, the authorized representative ensures that their contact information is available on the product label, packaging, and in the instructions for use                    <\/p>\r\n                <\/div>\r\n            <\/li>\r\n            <\/ul>\r\n    <\/div>\n\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-c5c9fa4 e-con-full cst-entitlements-box e-flex e-con e-child\" data-id=\"c5c9fa4\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2e95829 cst-title elementor-widget elementor-widget-heading\" data-id=\"2e95829\" data-element_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\"><span class=\"cst-color-text\">Rights<\/span> of an authorized representative agreement<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-471837c elementor-widget elementor-widget-shortcode\" data-id=\"471837c\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\">    <ul class=\"cst-entitlements-list cst-reset-list\">\r\n                    <li class=\"cst-item\">\r\n                <p class=\"cst-title\">Initiation of conformity assessment<\/p>\r\n                <p class=\"cst-text\">\r\n                    The authorized representative has the right to initiate conformity assessment procedures, submit the necessary documentation and product samples to the assessment bodies                <\/p>\r\n            <\/li>\r\n                    <li class=\"cst-item\">\r\n                <p class=\"cst-title\">Negotiations<\/p>\r\n                <p class=\"cst-text\">\r\n                    ensuring that the products comply with all requirements of Ukrainian legislation                <\/p>\r\n            <\/li>\r\n                    <li class=\"cst-item\">\r\n                <p class=\"cst-title\">Termination of sales<\/p>\r\n                <p class=\"cst-text\">\r\n                    In case of non-compliance or risks to consumers, the authorized representative has the right to initiate the withdrawal of products from the market                <\/p>\r\n            <\/li>\r\n            <\/ul>\r\n    <\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/section>\n\t\t<section class=\"elementor-element elementor-element-7c2c3c3 e-con-full cst-contact-section e-flex e-con e-child\" data-id=\"7c2c3c3\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-cebe442 e-con-full e-flex e-con e-child\" data-id=\"cebe442\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-b924f6b e-con-full e-flex e-con e-child\" data-id=\"b924f6b\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2362849 elementor-widget__width-initial cst-title elementor-widget elementor-widget-heading\" data-id=\"2362849\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><span class=\"cst-color-text\">Conclusion<\/span>  of an authorized representative agreement<\/h3>\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-746f9e0 e-con-full e-flex e-con e-child\" data-id=\"746f9e0\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bfddcfd elementor-widget elementor-widget-heading\" data-id=\"bfddcfd\" data-element_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\">An official agreement between the manufacturer and the authorized representative clearly defines the responsibilities, rights, and functions of each party<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ba69713 elementor-widget elementor-widget-heading\" data-id=\"ba69713\" data-element_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 provide support - from conformity assessment to product monitoring<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-546f6f6 e-con-full cst-btn-group-wp js-cst-btn-group blue e-flex e-con e-child\" data-id=\"546f6f6\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c8c2186 cst-primary-btn js-cst-open-form-btn elementor-tablet-align-justify elementor-widget-tablet__width-initial elementor-align-justify elementor-widget__width-initial elementor-widget elementor-widget-button\" data-id=\"c8c2186\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/en\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Get a consultation<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-470211b cst-primary-arrow-btn js-cst-open-form-btn elementor-widget elementor-widget-button\" data-id=\"470211b\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/en\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M17 7V17M17 7H7M17 7L7 17\" stroke=\"#141A2A\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>&nbsp; &nbsp; &nbsp;<\/p>","protected":false},"author":1,"featured_media":0,"parent":2920,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"no-sidebar","site-content-layout":"","ast-site-content-layout":"full-width-container","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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