{"id":290,"date":"2022-01-17T19:06:11","date_gmt":"2022-01-17T18:06:11","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=290"},"modified":"2023-07-03T12:55:52","modified_gmt":"2023-07-03T11:55:52","slug":"medical-devices-vigilance","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/medical-devices\/medical-devices-vigilance\/","title":{"rendered":"Medical Devices Vigilance"},"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  href=\"https:\/\/www.alims.gov.rs\/english\/turnover-and-consumption-of-medical-supplies\/\" 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\">Turnover and consumption of medical supplies<\/span><\/a><\/li><li  id=\"menu-item-286\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-286 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"286\"><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\/clinical-trials\/\" 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\">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 class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/surveillance\/\" 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\">Surveillance<\/span><\/a><\/li><li  id=\"menu-item-295\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-295 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"295\"><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\/complaints\/\" 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\">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>Medical Devices Vigilance<\/h5><\/h5><\/div><div class=\"fusion-text fusion-text-2\" style=\"--awb-text-transform:none;\"><p>The Medicines and Medical Devices Agency of Serbia, in accordance with the Law on Medical Devices (\u201cOfficial Gazette of the RS\u201d No. 105\/2017) and the Rulebook on Vigilance (\u201cOfficial Gazette of the RS\u201d, No. 3\/2019), organizes and monitors the vigilance medical devices.<\/p>\n<p><strong>Medical device vigilance<\/strong> is a set of activities related to the collection, evaluation, understanding and response to the knowledge about the risks arising from the use or application of a medical device, and especially with regard to reporting incidents in order to improve and protect the health and safety of patients and users and other persons and, if necessary, to provide information that reduces the likelihood \u00a0of recurrence of such incident in another place or that mitigates the consequences of that incident.<\/p>\n<p>An <strong>incident<\/strong> is any malfunction or deterioration of characteristics or performance of a medical device, as well as inadequacy in labeling or instructions for use.<br \/>\nThe applicable Law prescribes the obligation to appoint and report to the Agency <strong>a vigilance coordinator appointed by the healthcare institution<\/strong>. The vigilance coordinator informs the Agency and the manufacturer and\/or the manufacturer\u2019s authorized representative, of any incidents after the medical device has been marketed.<br \/>\nThe Agency has established a system for coordinators of healthcare institutions in the medical device vigilance system in June 2022, and an IT solution related to the use of ePortal MS is to be used during registration.<\/p>\n<p>Other ways of reporting an adverse reaction to a medical device: healthcare professionals, manufacturers and other users can report via <a href=\"https:\/\/www.alims.gov.rs\/medicinska-sredstva\/prijava-nezeljene-reakcije-na-medicinsko-sredstvo\/\" target=\"_blank\" rel=\"noopener\">a form<\/a>\u00a0&#8211; by email or by phone<\/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-290","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/290","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=290"}],"version-history":[{"count":3,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/290\/revisions"}],"predecessor-version":[{"id":825,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/290\/revisions\/825"}],"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=290"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}