{"id":1510,"date":"2025-05-25T17:02:03","date_gmt":"2025-05-25T17:02:03","guid":{"rendered":"https:\/\/medical-hub.info\/?page_id=1510"},"modified":"2026-02-23T08:41:46","modified_gmt":"2026-02-23T08:41:46","slug":"oczinka-vidpovidnosti-medychnyh-vyrobiv","status":"publish","type":"page","link":"https:\/\/medical-hub.info\/en\/services\/conformity-assessment-for-medical-devices\/","title":{"rendered":"Conformity assessment of medical devices"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"1510\" class=\"elementor elementor-1510\" data-elementor-post-type=\"page\">\n\t\t\t\t<section class=\"elementor-element elementor-element-59c4e6b cst-med-dev-hero e-flex e-con-boxed e-con e-parent\" data-id=\"59c4e6b\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-c37596d e-con-full e-flex e-con e-child\" data-id=\"c37596d\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-3abedcd e-con-full cst-breadcrums-box e-flex e-con e-child\" data-id=\"3abedcd\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-894bbd0 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=\"894bbd0\" 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-95cce80 cst-breadcrumbs js-cst-breadcrumbs elementor-widget-mobile__width-initial elementor-widget elementor-widget-hfe-breadcrumbs-widget\" data-id=\"95cce80\" 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-970cb41 e-con-full e-flex e-con e-child\" data-id=\"970cb41\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7cc9240 e-con-full e-flex e-con e-child\" data-id=\"7cc9240\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-67eee99 cst-hero-title elementor-widget elementor-widget-heading\" data-id=\"67eee99\" 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\">Conformity assessment <span class=\"cst-color-text\">for medical devices<\/span><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ff853ae elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"ff853ae\" 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 help your medical business meet standards and successfully launch products on the Ukrainian market<\/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-aee75ad e-con-full e-flex e-con e-child\" data-id=\"aee75ad\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-aa3f96b e-con-full cst-btn-group-wp red js-cst-btn-group e-flex e-con e-child\" data-id=\"aa3f96b\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e303044 cst-phone-btn cst-button-icon no-icon-tablet cst-primary-btn js-cst-phone blur elementor-tablet-align-justify elementor-widget-tablet__width-initial elementor-align-justify elementor-widget__width-initial elementor-widget elementor-widget-button\" data-id=\"e303044\" 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=\"#\">\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\">+38 093 414 02 22<\/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-4cf1580 cst-phone-btn cst-button-icon cst-primary-arrow-btn js-cst-phone-icon blur elementor-widget elementor-widget-button\" data-id=\"4cf1580\" 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=\"#\">\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=\"M11.7925 14.742L9.25195 12.2057C8.43422 11.3893 8.43422 10.0657 9.25195 9.24935C9.98275 8.51977 10.071 7.36701 9.45987 6.53498L7.37385 3.69514C6.75631 2.85444 5.53346 2.76108 4.79506 3.49826C3.67086 4.62058 2.91814 6.10588 3.00713 7.6906C3.44184 15.4326 9.49836 20.6079 16.3476 20.993C17.9183 21.0813 19.3811 20.3229 20.4935 19.2123C21.2429 18.4642 21.148 17.2252 20.2933 16.5995L17.4726 14.5344C16.6392 13.9242 15.4845 14.0124 14.7537 14.742C13.936 15.5583 12.6102 15.5583 11.7925 14.742Z\" stroke=\"#D78861\" 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<div class=\"elementor-element elementor-element-53374ff e-con-full cst-btn-group-wp js-cst-btn-group blue e-flex e-con e-child\" data-id=\"53374ff\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-595a1a8 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=\"595a1a8\" 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-6910c0c cst-primary-arrow-btn js-cst-open-form-btn elementor-widget elementor-widget-button\" data-id=\"6910c0c\" 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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/section>\n\t\t<section class=\"elementor-element elementor-element-579a967 cst-about-section e-flex e-con-boxed e-con e-parent\" data-id=\"579a967\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-b519f00 e-con-full e-flex e-con e-child\" data-id=\"b519f00\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7338196 cst-about-title-top elementor-widget elementor-widget-heading\" data-id=\"7338196\" 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\">Procedure <\/span>of conformity assessment<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f70076f elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"f70076f\" 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\">In order to import and sell medical devices in Ukraine, it is necessary to undergo a conformity assessment procedure, which is determined in accordance with the Technical Regulations<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4731b70 elementor-widget elementor-widget-heading\" data-id=\"4731b70\" 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\">THE CHOICE OF REGULATIONS DEPENDS ON THE TYPE OF PRODUCT:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c70b53d elementor-widget elementor-widget-shortcode\" data-id=\"c70b53d\" 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-rule-list cst-reset-list\">\r\n                                    <li class=\"cst-item\">\r\n                    <p class=\"cst-title\">General medical devices<\/p>\r\n                    <p class=\"cst-rule\">CMU Resolution No. 753<\/p>\r\n                <\/li>\r\n                            <li class=\"cst-item\">\r\n                    <p class=\"cst-title\">In vitro diagnostic devices<\/p>\r\n                    <p class=\"cst-rule\">CMU Resolution No. 754<\/p>\r\n                <\/li>\r\n                            <li class=\"cst-item\">\r\n                    <p class=\"cst-title\">Active implantable medical devices<\/p>\r\n                    <p class=\"cst-rule\">CMU Resolution No. 755<\/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 class=\"elementor-element elementor-element-329582e cst-methods-title elementor-widget elementor-widget-heading\" data-id=\"329582e\" 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\">Methods<\/span> of conformity assessment<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0c50a3b elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"0c50a3b\" 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\">Assessment procedures depend on the risk class and characteristics of the product<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c24e419 elementor-widget elementor-widget-heading\" data-id=\"c24e419\" 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\">WE OFFER SEVERAL OPTIONS FOR DIFFERENT TYPES OF PRODUCTS:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c47ea2 elementor-widget elementor-widget-shortcode\" data-id=\"1c47ea2\" 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                        <a href=\"https:\/\/medical-hub.info\/en\/services\/conformity-assessment-for-medical-devices\/self-declaration\/\"\r\n                            class=\"cst-service-name\">Self-declaration<\/a>\r\n\r\n                        <div class=\"cst-desc-box\">\r\n                            <p class=\"cst-service-note\">Used for low-risk products<\/p>\r\n                            <p class=\"cst-service-decs\">\r\n                                The manufacturer or its authorized representative prepares technical documentation, completes a checklist, and draws up a declaration of conformity. It is important to note that the declaration does not require additional confirmation by a conformity assessment body                            <\/p>\r\n                        <\/div>\r\n                    <\/div>\r\n                <\/li>\r\n                            <li class=\"cst-item\">\r\n                    <div class=\"cst-box\">\r\n                        <a href=\"https:\/\/medical-hub.info\/en\/services\/conformity-assessment-for-medical-devices\/conformity-assessment-through-audit\/\"\r\n                            class=\"cst-service-name\">Conformity assessment by audit<\/a>\r\n\r\n                        <div class=\"cst-desc-box\">\r\n                            <p class=\"cst-service-note\">For products with a higher risk<\/p>\r\n                            <p class=\"cst-service-decs\">\r\n                                The procedure involves auditors visiting the manufacturer to check the quality management system. The audit is conducted by a Ukrainian conformity assessment body, which issues a certificate valid for five years upon successful completion. Based on the certificate, the manufacturer draws up a declaration of conformity                            <\/p>\r\n                        <\/div>\r\n                    <\/div>\r\n                <\/li>\r\n                            <li class=\"cst-item\">\r\n                    <div class=\"cst-box\">\r\n                        <a href=\"https:\/\/medical-hub.info\/en\/services\/conformity-assessment-for-medical-devices\/recognition-of-results\/\"\r\n                            class=\"cst-service-name\">Recognition of the results of the European notified body<\/a>\r\n\r\n                        <div class=\"cst-desc-box\">\r\n                            <p class=\"cst-service-note\">If there are appropriate agreements between the Ukrainian and European bodies, the results of conformity assessment can be recognized<\/p>\r\n                            <p class=\"cst-service-decs\">\r\n                                This reduces the amount of necessary procedures and costs, but the Ukrainian certificate is valid only for the period of validity of the European certificate                            <\/p>\r\n                        <\/div>\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\t\t\t<\/div>\n\t\t\t\t<\/section>\n\t\t<div class=\"elementor-element elementor-element-e92d09e cst-contact-us-section e-flex e-con-boxed e-con e-parent\" data-id=\"e92d09e\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-d9702c6 e-con-full e-flex e-con e-child\" data-id=\"d9702c6\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-e3d04fa e-con-full e-flex e-con e-child\" data-id=\"e3d04fa\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3d1cd80 cst-contact-title elementor-widget elementor-widget-heading\" data-id=\"3d1cd80\" 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\"><span class=\"cst-color-text\">Need help<\/span>, <br \/>\r\nor have questions?<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5cbe470 elementor-widget elementor-widget-heading\" data-id=\"5cbe470\" 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\">Leave a request and we will contact you shortly<\/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-fd158d3 e-con-full e-flex e-con e-child\" data-id=\"fd158d3\" data-element_type=\"container\" 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