{"id":284,"date":"2022-01-17T18:42:20","date_gmt":"2022-01-17T17:42:20","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=284"},"modified":"2023-07-03T12:43:23","modified_gmt":"2023-07-03T11:43:23","slug":"clinical-trials","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/medical-devices\/clinical-trials\/","title":{"rendered":"Clinical Trials"},"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:1248px;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_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:7.68%;--awb-width-medium:25%;--awb-order-medium:0;--awb-spacing-right-medium:7.68%;--awb-spacing-left-medium:7.68%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-font-size:16px;--awb-text-transform:none;--awb-text-color:var(--awb-color1);--awb-text-font-family:&quot;Source Sans Pro&quot;;--awb-text-font-style:normal;--awb-text-font-weight:700;\" id=\"navigacija_naslov\"><p>Medical devices<\/p>\n<\/div><nav class=\"awb-menu awb-menu_column awb-menu_em-hover mobile-mode-collapse-to-button awb-menu_icons-left awb-menu_dc-yes mobile-trigger-fullwidth-off awb-menu_mobile-toggle awb-menu_indent-left mobile-size-full-absolute loading mega-menu-loading awb-menu_desktop awb-menu_dropdown awb-menu_expand-right awb-menu_transition-fade\" style=\"--awb-font-size:14px;--awb-items-padding-bottom:0.5em;--awb-color:#0d4873;--awb-active-color:#0d4873;--awb-main-justify-content:flex-start;--awb-mobile-justify:flex-start;--awb-mobile-caret-left:auto;--awb-mobile-caret-right:0;--awb-fusion-font-family-typography:&quot;Source Sans Pro&quot;;--awb-fusion-font-style-typography:normal;--awb-fusion-font-weight-typography:700;--awb-fusion-font-family-submenu-typography:inherit;--awb-fusion-font-style-submenu-typography:normal;--awb-fusion-font-weight-submenu-typography:400;--awb-fusion-font-family-mobile-typography:inherit;--awb-fusion-font-style-mobile-typography:normal;--awb-fusion-font-weight-mobile-typography:400;\" aria-label=\"meni_med_sredstva\" data-breakpoint=\"1024\" data-count=\"0\" data-transition-type=\"fade\" data-transition-time=\"300\"><button type=\"button\" class=\"awb-menu__m-toggle awb-menu__m-toggle_no-text\" aria-expanded=\"false\" aria-controls=\"menu-meni_med_sredstva\"><span class=\"awb-menu__m-toggle-inner\"><span class=\"collapsed-nav-text\"><span class=\"screen-reader-text\">Toggle Navigation<\/span><\/span><span class=\"awb-menu__m-collapse-icon awb-menu__m-collapse-icon_no-text\"><span class=\"awb-menu__m-collapse-icon-open awb-menu__m-collapse-icon-open_no-text fa-bars fas\"><\/span><span class=\"awb-menu__m-collapse-icon-close awb-menu__m-collapse-icon-close_no-text fa-times fas\"><\/span><\/span><\/span><\/button><ul id=\"menu-meni_med_sredstva\" class=\"fusion-menu awb-menu__main-ul awb-menu__main-ul_column\"><li  id=\"menu-item-279\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-279 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"279\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Medical devices<\/span><\/a><\/li><li  id=\"menu-item-283\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-283 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"283\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/registration-in-the-register-of-medical-devices\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Registration in the Register of Medical Devices<\/span><\/a><\/li><li  id=\"menu-item-289\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-289 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"289\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/expert-opinions\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Expert opinions<\/span><\/a><\/li><li  id=\"menu-item-806\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-806 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"806\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/a-group-of-generic-medicinal-products\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">A group of generic medicinal products<\/span><\/a><\/li><li  id=\"menu-item-807\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-807 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"807\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/advertising-of-medical-devices\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Advertising of medical devices<\/span><\/a><\/li><li  id=\"menu-item-808\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-808 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"808\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  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class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Clinical Trials<\/span><\/a><\/li><li  id=\"menu-item-292\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-292 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"292\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/medical-devices-vigilance\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Medical Devices Vigilance<\/span><\/a><\/li><li  id=\"menu-item-809\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-809 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"809\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/reporting-an-adverse-reaction-to-a-medical-device-incident\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Reporting an adverse reaction to a medical device (INCIDENT)<\/span><\/a><\/li><li  id=\"menu-item-810\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-810 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"810\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span 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fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Complaints<\/span><\/a><\/li><li  id=\"menu-item-297\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-297 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"297\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/search-for-medical-devices\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Search for medical devices<\/span><\/a><\/li><li  id=\"menu-item-299\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-299 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"299\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/search-for-veterinary-medical-devices\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Search for veterinary medical devices<\/span><\/a><\/li><li  id=\"menu-item-306\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-306 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"306\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/search-for-medical-device-manufacturers\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Search for medical device manufacturers<\/span><\/a><\/li><li  id=\"menu-item-304\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-304 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"304\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/search-for-authorized-representatives-of-medical-device-manufacturers\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Search for authorized representatives of medical device manufacturers<\/span><\/a><\/li><li  id=\"menu-item-811\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-811 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"811\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/important-notices\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Important notices<\/span><\/a><\/li><\/ul><\/nav><\/div><\/div>\n<div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-flex-column\" style=\"--awb-padding-right:50px;--awb-bg-size:cover;--awb-width-large:75%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.56%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:2.56%;--awb-width-medium:75%;--awb-order-medium:0;--awb-spacing-right-medium:2.56%;--awb-spacing-left-medium:2.56%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><nav class=\"fusion-breadcrumbs fusion-breadcrumbs-1\" style=\"--awb-breadcrumb-sep:&#039;\/&#039;;\" aria-label=\"Breadcrumb\"><ol class=\"awb-breadcrumb-list\"><li class=\"fusion-breadcrumb-item awb-breadcrumb-sep\" ><a href=\"https:\/\/www.alims.gov.rs\/english\" class=\"fusion-breadcrumb-link\"><span >Home<\/span><\/a><\/li><\/ol><\/nav><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-five\"><h5 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><h5>Clinical Trials<\/h5><\/h5><\/div><div class=\"fusion-text fusion-text-2\" style=\"--awb-text-transform:none;\"><p>Clinical trials of medical devices are carried out based on the following:<br \/>\n1. <strong>Authorization<\/strong> for conducting or <strong>certificate of registration<\/strong> of a clinical trial (CT) issued by the Agency and<br \/>\n2. <strong>Positive opinion given by the Ethics Committee of Serbia (ECS)<\/strong><br \/>\nin accordance with the Law on Medical Devices (\u201cOfficial Gazette of RS\u201d, No. 105\/2017) and the regulations adopted for its implementation.<br \/>\n<strong>The request for authorization or certificate of registration of a clinical trial and the request for the opinion of the Ethics Committee of Serbia are submitted through the Agency concurrently..<\/strong><\/p>\n<p><em>II. Types of requests submitted to the Agency regarding CT of medical devices:<\/em><\/p>\n<p>A) <strong>Request for authorization of a clinical trial of a medical device<\/strong><br \/>\n(issuance of a <strong>license for authorization<\/strong> of a clinical trial of a medical device)<\/p>\n<p>Prior to the start of a clinical trial, the sponsor submits to the Agency a request with the documentation for the authorization of a clinical trial of a medical device for the following medical devices:<br \/>\n\u2022 <strong>class IIa which are for long-term use or invasive;<\/strong><br \/>\n<strong>\u2022 class IIb;<\/strong><br \/>\n<strong>\u2022 class III;<\/strong><br \/>\n<strong>\u2022 active implantable medical devices (AIMD).<\/strong><\/p>\n<p>*An EOS application is submitted concurrently<\/p>\n<p>B) <strong>Registration of a clinical trial of a medical device<\/strong><\/p>\n<p>(issuance <strong>of certificate of receipt of registration<\/strong>)<\/p>\n<p>The sponsor reports to the Agency the implementation of:<\/p>\n<p>1) <strong>post-marketing non-interventional<\/strong> clinical trial of a medical device;<\/p>\n<p>2) clinical trial of <strong>Class I<\/strong> medical devices;<\/p>\n<p>3) clinical trial of class <strong>IIa medical devices that are not<\/strong><br \/>\n<strong>intended for long-term use or are invasive;<\/strong><\/p>\n<p>4) Performance evaluation studies of <strong>in vitro diagnostic medical devices<\/strong>;<\/p>\n<p>*An EOS application is submitted concurrently<\/p>\n<p>C) <strong>Non-commercial clinical trial of a medical device (academic clinical trial of a medical device)<\/strong><\/p>\n<p>The instructions from item No. A) and B) shall apply, depending on the type of application submitted to the Agency.<\/p>\n<p>*An EOS application is submitted concurrently<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":273,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-284","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/284","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/comments?post=284"}],"version-history":[{"count":3,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/284\/revisions"}],"predecessor-version":[{"id":822,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/284\/revisions\/822"}],"up":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/273"}],"wp:attachment":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/media?parent=284"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}