{"id":281,"date":"2022-01-17T18:39:01","date_gmt":"2022-01-17T17:39:01","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=281"},"modified":"2023-06-20T11:36:30","modified_gmt":"2023-06-20T10:36:30","slug":"registration-in-the-register-of-medical-devices","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/medical-devices\/registration-in-the-register-of-medical-devices\/","title":{"rendered":"Registration in the Register of Medical Devices"},"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 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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\" 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class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><h5>Registration in the Register of Medical Devices<\/h5><\/h5><\/div><div class=\"fusion-text fusion-text-2\" style=\"--awb-text-transform:none;\"><p>Within the system of health-care service provision, and for the purposes of disease prevention, diagnosis, treatment, and rehabilitation of the Serbian population, it is necessary to provide the widest range of quality, safe and efficient medical devices and thus prevent marketing of low-grade and unregistered products.<\/p>\n<p>Legally regulated marketing of medical devices in Serbia has been carried out since 1993, when the field of production and marketing of medical devices was regulated for the first time in our country by the Law on Production and Trade of Medicines. Based on the Law on Medicinal Products and Medical Devices, adopted in 2010, medical devices were registered in the Register, as a requirement for their marketing in our country.<\/p>\n<p>The new Law on Medical Devices was adopted in 2017, and its full implementation began at the end of 2018. In accordance with the applicable Law and by-laws adopted for its implementation (<a href=\"https:\/\/www.alims.gov.rs\/regulativa\/medicinska-sredstva\/pravilnici\/\" target=\"_blank\" rel=\"noopener\">regulations<\/a>), ALIMS&#8217; activities in the field of medical devices are carried out in electronic form, in accordance with the law governing electronic operations. The application for registration of a medical device is submitted by the manufacturer, or by the authorized representative of the manufacturer of medical devices.<\/p>\n<p>ALIMS maintains the \u201cRegister of Medical Devices\u201d, including all relevant data related to medical devices registered in the Republic of Serbia. Also, ALIMS registers in the \u201cRegister of Manufacturers\u201d all foreign manufacturers (including their representative offices and \u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0458\u0430 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0430\u0432\u0430<br \/>\nRegistration in the Register of Medical Devices Within the system of health-care service provision, and for the purposes of disease prevention, diagnosis, treatment, and rehabilitation of the Serbian population, it is necessary to provide the widest range of quality, safe and efficient medical devices and thus prevent marketing of low-grade and unregistered products.<\/p>\n<p>Legally regulated marketing of medical devices in Serbia has been carried out since 1993, when the field of production and marketing of medical devices was regulated for the first time in our country by the Law on Production and Trade of Medicines. Based on the Law on Medicinal Products and Medical Devices, adopted in 2010, medical devices were registered in the Register, as a requirement for their marketing in our country.<\/p>\n<p>The new Law on Medical Devices was adopted in 2017, and its full implementation began at the end of 2018. In accordance with the applicable Law and by-laws adopted for its implementation (regulations), ALIMS&#8217; activities in the field of medical devices are carried out in electronic form, in accordance with the law governing electronic operations. The application for registration of a medical device is submitted by the manufacturer, or by the authorized representative of the manufacturer of medical devices.<\/p>\n<p>ALIMS maintains the \u201cRegister of Medical Devices\u201d, including all relevant data related to medical devices registered in the Republic of Serbia. Also, ALIMS registers in the \u201cRegister of Manufacturers\u201d all foreign manufacturers (including their representative offices and branches), whose medical devices are registered in the Republic of Serbia, as well as all domestic manufacturers of medical devices. Registration of a medical device is submitted on Form 1 with the appropriate documentation and proof of payment. The application may refer to the registration of multiple medical devices having the same category and risk class, manufactured by the same manufacturer, which are covered by the same certificates of conformity. The trade of registered medical devices is carried out based on a valid decision on registration.<\/p>\n<p>ALIMS issues a decision on registration of a medical device, valid 60 days after the expiry of the validity term of the certificate of conformity. Medical devices can be marketed for a maximum of 90 days from the date of expiry of the decision on registration of a medical device.<\/p>\n<p>In accordance with the Law, ALIMS may authorize the trade of unregistered medical devices, only at the request of import proponent (health care institution, private practice, social welfare institution, humanitarian organization, patient association and the ministry responsible for defense affairs and the ministry responsible for emergency situations).<\/p>\n<p>ALIMS also issues approvals for clinical trials of medical devices and monitors their safety, i.e. vigilance, as well as the surveillance of medical devices in the market.<\/p>\n<p>ALIMS regularly publishes on its official website the &#8220;Register of Medical Devices&#8221;, the &#8220;Register of Manufacturers&#8221; and the &#8220;Register of Authorized Representatives of Manufacturers of Medical Devices&#8221;.<\/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-281","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/281","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=281"}],"version-history":[{"count":3,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/281\/revisions"}],"predecessor-version":[{"id":769,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/281\/revisions\/769"}],"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=281"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}