{"id":273,"date":"2022-01-17T18:27:26","date_gmt":"2022-01-17T17:27:26","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=273"},"modified":"2023-05-25T10:41:18","modified_gmt":"2023-05-25T09:41:18","slug":"medical-devices","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/medical-devices\/","title":{"rendered":"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 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<\/h5><\/h5><\/div><div class=\"fusion-title title fusion-title-2 fusion-sep-none fusion-title-text fusion-title-size-four\"><h4 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><h4>General Medical Devices<\/h4><\/h4><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-bottom:10px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;border-color:var(--awb-color3);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-2\" style=\"--awb-text-transform:none;\"><p>General medical device means any instrument, apparatus, appliance and product intended to be used, alone or in combination, for human beings for the following purpose:<\/p>\n<p>1) Diagnosis, prevention, monitoring, treatment or alleviation of disease,<br \/>\n2) Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,<br \/>\n3) Investigation, replacement or modification of the anatomy or of a physiological process,<br \/>\n4) Control of conception,<br \/>\nA medical device is also considered to be a device which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.<br \/>\nGeneral medical devices include accessories which are not considered to be a medical device by definition and refer to products which when used together with the medical device enable the functioning of such medical device in accordance with its intended purpose specified by the manufacturer.<br \/>\nGeneral medical devices also include custom-made devices which are specifically manufactured in accordance with the prescription of the appropriate health-care professional intended for the sole use of a particular patient.<\/p>\n<p>General medical devices are classified as follows:<br \/>\n1) Based on the risk for the user:<br \/>\n\u2013 Class I \u2013 Medical devices with the low level of risk for the user;<br \/>\n\u2013 Class II(a) \u2013 Medical devices with a medium level of risk for the user;<br \/>\n\u2013 Class II(b) \u2013 Medical devices with a high level of risk for the user;<br \/>\n\u2013 Class III \u2013 Medical devices with the highest level of risk for the user.<br \/>\n2) Based on the nature of a medical device, its connection to an energy source and other characteristics, medical devices can be:<br \/>\n\u2013 Non-invasive;<br \/>\n\u2013 Invasive; and<br \/>\n\u2013 Active.<br \/>\n3) Based on the duration of application in or on the human body, medical devices can be:<br \/>\n\u2013 Transient use (intended for continuous use no longer than 60 minutes);<br \/>\n\u2013 Short-term use (intended for continuous use for no more than 30 days);<br \/>\n\u2013 Long-term use (intended for continuous use for no less than 30 days).<\/p>\n<\/div><div class=\"fusion-title title fusion-title-3 fusion-sep-none fusion-title-text fusion-title-size-four\"><h4 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><h4>In vitro Diagnostic Medical Devices<\/h4><\/h4><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-bottom:10px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;border-color:var(--awb-color3);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-3\" style=\"--awb-text-transform:none;\"><p><em>In vitro diagnostic medical devices<\/em> include any reagents, reagent products, control and calibration materials, reagent kits, instruments, apparatuses, equipment or systems, used independently or in combination, intended to be used in <em>In vitro<\/em> conditions for the examination of samples, including blood and tissue samples from the human body, in order to obtain the following information:<\/p>\n<p>\u2022 Concerning physiological or pathological state;<br \/>\n\u2022 Concerning congenital abnormalities;<br \/>\n\u2022 For determining the safety and compatibility of a potential recipient;<br \/>\n\u2022 For monitoring therapeutic measures.<\/p>\n<p>Specimen containers are considered to be in vitro diagnostic medical devices, i.e. vacuum\u2010type device or non-vacuum-type for the primary containment and preservation of samples derived from the human body for the purpose of in vitro diagnostic examination.<br \/>\nA self-testing device refers to any in vitro diagnostic medical device intended to be used by an unskilled person in their environment.<br \/>\nPerformance evaluation device refers to any in vitro diagnostic medical device intended to be a subject of one or more studies for performance evaluation conducted in medical analysis laboratories or in any other appropriate environment outside its own premises.<br \/>\nCalibrator and control material refer to any substance, material or product intended for determining measuring proportions or testing performance properties of a certain device in relation to its originally intended purpose.<br \/>\nIn vitro diagnostic medical devices do not include products intended for general laboratory use, unless these products are specifically intended for use in in vitro diagnostic testing by the manufacturer.<\/p>\n<p>Classification of &lt;em Diagnostic Medical Devices&lt;\/em<\/p>\n<p>1) A list:<br \/>\n\u2013 Reagents and reagent products including the materials for control and calibration used for determining the following blood types: ABO blood group system, Rhesus Factor (C, c, D, E, e) \u201canti\u2010Kell\u201d;<br \/>\n\u2013 Reagents and reagent products including the materials for control and calibration used for detection, confirmation and quantisation of HIV infection markers (HIV 1 and 2), HTLV I and II, and Hepatitis B, C, D in human samples.<\/p>\n<p>2) B list:<br \/>\n\u2013 Reagents and reagent products, as well as the materials for control and calibration used for determining of the following blood types: \u201canti\u2010Duffy\u201d and \u201canti\u2010Kidd\u201d;<br \/>\n\u2013 Reagents and reagent products, as well as the materials for control and calibration used for detection of the unacceptable anti\u2010erythrocyte antibodies;<br \/>\n\u2013 Reagents and reagent products, as well as the materials for control and calibration used in detecting and quantifying similar infections: Rubella, Toxoplasmosis, and the like in human samples;<br \/>\n\u2013 Reagents and reagent products, as well as the materials for control and calibration used for the diagnosis of hereditary diseases (Phenylketonuria);<br \/>\n\u2013 Reagents and reagent products, as well as the materials for control and calibration used for detecting human infections (Cytomegalovirus and Chlamydia);<br \/>\n\u2013 Reagents and reagent products, as well as the materials for control and calibration used for determining HLA tissue groups (DR, A, B);<br \/>\n\u2013 Reagents and reagent products, materials for control and calibration, as well as the control materials for determining tumour markers (PSA);<br \/>\n\u2013 Reagents and reagent products, as well as the materials for control and calibration, and the software for determining the specificity of the hereditary risk for trisomy 21;<br \/>\n\u2013 Products for self\u2010diagnosis, as well as the materials for control and calibration (products for measuring blood sugar levels);<br \/>\n3) In vitro diagnostic medical devices for SELF\u2010TESTING;<br \/>\n4) OTHER in vitro diagnostic medical devices.<\/p>\n<\/div><div class=\"fusion-title title fusion-title-4 fusion-sep-none fusion-title-text fusion-title-size-four\"><h4 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><h4>Active Implantable Medical Devices<\/h4><\/h4><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-bottom:10px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;border-color:var(--awb-color3);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-4\" style=\"--awb-text-transform:none;\"><p>Active implantable medical devices are the products whose actions depend on the source of electricity or any other energy sources that are not powered directly from the human body or gravity, and are intended to be either fully or partially introduced into the human body by surgical intervention, or to be permanently placed in the body openings.<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-273","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/273","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=273"}],"version-history":[{"count":4,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/273\/revisions"}],"predecessor-version":[{"id":693,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/273\/revisions\/693"}],"wp:attachment":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/media?parent=273"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}