{"id":15707,"date":"2024-04-24T09:09:29","date_gmt":"2024-04-24T07:09:29","guid":{"rendered":"https:\/\/cinmed.me\/medical-devices\/interventni-uvoz\/"},"modified":"2026-03-19T14:08:10","modified_gmt":"2026-03-19T13:08:10","slug":"interventni-uvoz","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/medical-devices\/interventni-uvoz\/","title":{"rendered":"Emergency import"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"15707\" class=\"elementor elementor-15707 elementor-15696\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3ca1b3a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3ca1b3a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-28611e1\" data-id=\"28611e1\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9e6cb7e elementor-widget elementor-widget-image\" data-id=\"9e6cb7e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2024\/04\/interventni-uvoz.jpg\" class=\"attachment-large size-large wp-image-15698\" alt=\"\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2024\/04\/interventni-uvoz.jpg 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2024\/04\/interventni-uvoz-150x150.jpg 150w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/>\t\t\t\t\t\t\t\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-b373f52 elementor-widget elementor-widget-text-editor\" data-id=\"b373f52\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In accordance with the Law on medical devices, the Institute may approve import of medical devices that are not registered in following cases:<\/p><ul><li>In case of urgent medical need for a specific patient or group of patients, and no registered medical device is available on the market of Montenegro that can in an equally safe manner help patient or group of patients in question;<\/li><li>In case of insufficient quantities of registered medical devices of relevant purpose on the market of Montenegro to address the needs of public health protection;<\/li><li>for research purposes;<\/li><li>for clinical trials;<\/li><li>in case of natural disasters, or<\/li><li>other emergency situations.<\/li><\/ul><p>\u00a0<\/p>\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-bc1bd6b elementor-widget elementor-widget-text-editor\" data-id=\"bc1bd6b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Emergency import may include unregistered medical devices that are donations or humanitarian aid, as well as unregistered medical devices that have been on the market or in use.<\/p><p>The import of an unregistered medical device may be proposed by a health institution, a scientific and research institution, a social and child welfare institution providing health care, a humanitarian organization, a state administration body responsible for defense affairs, a state administration body responsible for health affairs, and a state administration body responsible for internal affairs. An application for import authorisation for unregistered medical device on behalf and for the account of the import proposer shall be submitted to the Institute by a legal person possessing a wholesale authorisation for medical devices &#8211; wholesaler. The application may be submitted for import of one unregistered medical device for the needs of several import proposers or for several unregistered medical devices for the needs of one import proposer. The application shall be submitted using the Form available on the Institute&#8217;s website.<\/p>\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-80f6d3f elementor-widget elementor-widget-text-editor\" data-id=\"80f6d3f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Within 30 days from the date of receipt of a complete application the Institute shall issue a decision approving or rejecting the application for issuance of import authorisation for unregistered medical device.<\/p><ul><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/Obrazac-zahtjev-za-izdavanje-odobrenja-za-uvoz-medicinskih-sredstava-koja-nijesu-registrovana.docx\">Application form for requesting authorization to import medical devices that are not registered<\/a>\u00a0<em>(a\u017eurirano 25.1.2023. godine<\/em>)<\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/03\/Za851.166-02-IMS-Obrazlozeni-predlog-izjava-predlagaca-za-uvoz-medicinskih-sredstava-koja-nijesu-registrovana.docx\">Reasoned proposal \/ statement by the applicant for the import of unregistered medical devices<\/a>\u00a0<em>(a\u017eurirano 3.3.2023. godine<\/em>)<\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/03\/Documentation-required-for-issuance-of-import-authorisation-for-medical-devices-that-are-not-registered.pdf\" target=\"_blank\" rel=\"noopener\">Documentation required for issuance of import authorisation for medical devices that are not registered<\/a><em>(a\u017eurirano 18.3.2026.)<\/em><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ad1eb4e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ad1eb4e\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ab03345\" data-id=\"ab03345\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>In accordance with the Law on medical devices, the Institute may approve import of medical devices that are not registered in following cases: In case of urgent medical need for a specific patient or group of patients, and no registered medical device is available on the market of Montenegro that can in an equally safe [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":7507,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"cinmed-template-custom.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-15707","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - 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