{"id":7554,"date":"2022-11-21T01:28:28","date_gmt":"2022-11-21T01:28:28","guid":{"rendered":"https:\/\/cinmed.me\/regulativa\/regulativa-medicinskih-sredstava\/"},"modified":"2026-02-26T09:39:01","modified_gmt":"2026-02-26T08:39:01","slug":"medical-devices","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/legislation\/medical-devices\/","title":{"rendered":"Medical devices"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7554\" class=\"elementor elementor-7554 elementor-1115\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b1cc3b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b1cc3b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wider\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-b11a068\" data-id=\"b11a068\" 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-ce4b035 elementor-widget elementor-widget-image\" data-id=\"ce4b035\" 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=\"800\" height=\"450\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/11\/Regulativa-medicinskih-sredstava.jpg\" class=\"attachment-large size-large wp-image-1915\" alt=\"\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/11\/Regulativa-medicinskih-sredstava.jpg 800w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/11\/Regulativa-medicinskih-sredstava-300x169.jpg 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/11\/Regulativa-medicinskih-sredstava-768x432.jpg 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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-bdcac82 elementor-widget elementor-widget-heading\" data-id=\"bdcac82\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Medical devices<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-89369d3 elementor-widget elementor-widget-text-editor\" data-id=\"89369d3\" 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<ul><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2025\/07\/Law-on-Medical-Devices.pdf\" target=\"_blank\" rel=\"noopener\">Law on medical devices<\/a> (\u201cOfficial Gazette of Montenegro\u201d, No. 024\/19)<\/li><li><a href=\"\/wp-content\/uploads\/2022\/11\/Zakon-o-upravnom-postupku.pdf\" target=\"_blank\" rel=\"noopener\">Law on administrative procedure<\/a> <i>(&#8220;Official Gazette of Montenegro&#8221; No 056\/14, 020\/15, 040\/16 and 037\/17<\/i>) \u2013 document in Montenegrin;<\/li><\/ul><p><b>Note<\/b>: <em>this act is applied to all procedures initiated upon 1 July 2017<\/em><\/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-a94a495 elementor-widget elementor-widget-heading\" data-id=\"a94a495\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Rulebooks<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-65f098d elementor-widget elementor-widget-text-editor\" data-id=\"65f098d\" 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 (&#8220;Official Gazette of Montenegro&#8221;, No. 24\/19)<\/p><ul><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2024\/03\/Pravilnik-o-osnovnim-zahtjevima-za-medicinska-sredstva_za-prevod-na-engleski-jezik.pdf\" target=\"_blank\" rel=\"noopener\">Rulebook on basic requirements for medical devices <\/a>(Official gazette of Montenegro, No 008\/24)<\/li><li><p><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/05\/Pravilnik-o-obiljezavanju-ms_eng.pdf\" target=\"_blank\" rel=\"noopener\">Rulebook on labelling and content of the instructions for use for a medical device <\/a>(Official gazette of Montenegro, No 047\/23)<\/p><\/li><li><p><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/05\/Pravilnik-o-blizim-uslovima-i-nacinu-oglasavanja-medicinskih-sredstava-za-mariju.pdf\">Rulebook on more detailed conditions and manner of advertising of medical devices <\/a>(Official Gazette of Montenegro, No. 042\/23)<\/p><\/li><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/05\/Rulebook-on-recognition-of-foreign-documents-and-CE-mark-and-on-registra....pdf\" target=\"_blank\" rel=\"noopener\">Rulebook on recognition of foreign documents and CE mark and on registration of medical devices<\/a> (Official Gazette of Montenegro, No. 85\/22, 126\/22)<\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2024\/11\/Rulebook-on-more-detailed-conditions-and-method-of-determining-the-fulfillment-of-conditions-for-the-retail-sale-of-medical-devices.pdf\" target=\"_blank\" rel=\"noopener\">Rulebook on more detailed conditions and method of determining the fulfillment of conditions for the retail sale of medical devices<\/a> (Official Gazette of Montenegro, No. 57\/22, 126\/22, 99\/24)<\/li><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/05\/Rulebook-on-mored-detailed-conditions-for-import-of-medical-devices-that....pdf\" target=\"_blank\" rel=\"noopener\">Rulebook on more detailed conditions for import of medical devices that are not registered<\/a> (Official Gazette of Montenegro, No. 73\/22, 126\/22)<\/li><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/05\/Rulebook-on-more-detailed-conditions-and-manner-of-determining-the-fulfillment-of-conditions-for-the-wholesale-of-medical-devices.pdf\" target=\"_blank\" rel=\"noopener\">Rulebook on more detailed conditions and manner of determining the fulfillment of conditions for the wholesale of medical devices<\/a> (Official Gazette of Montenegro, No. 132\/21, 72\/22)<\/li><\/ul>\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-187e71c elementor-widget elementor-widget-heading\" data-id=\"187e71c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Good Distribution Practice guidelines for Medical Devices<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-84a926f elementor-widget elementor-widget-text-editor\" data-id=\"84a926f\" 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><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/GUIDELINES-OF-GOOD-DISTRIBUTION-PRACTICE-FOR-MEDICAL-DEVICES.pdf\" target=\"_blank\" rel=\"noopener\">Guidelines on Good Distribution Practice for Medical Devices<\/a> (published on 13.12.2021.)<\/p>\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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-c99dd92\" data-id=\"c99dd92\" 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-d1b992c elementor-widget elementor-widget-shortcode\" data-id=\"d1b992c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"relative pt-10 rounded bg-primary pb-72\">\n\t<h1 class=\"ml-10 text-4xl text-white \">Search <span class=\"font-bold\">register<\/span><\/h1>\n\t<div class=\"mt-8 \">\n\t\t<h3 class=\"mb-4 ml-10 text-secondary text-medium \">Here you can search for medicines in our register<\/h3>\n\t\t<div class=\"relative inline-block w-4\/5 ml-10 text-left\" style=\"width:80%\">\n\t\t\t<div>\n\t\t\t\t<select onchange=\"javascript:handleSelect(this)\" class=\"block h-[52px] text-[18px] text-light appearance-none w-full bg-white py-3 px-4 pr-8 rounded leading-tight focus:outline-none focus:bg-white focus:border-none\">\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\">Choose register<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/register-of-medicines-for-human-use\/\">Register of medicines for human use<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/register-of-veterinary-medicines\/\">Register of veterinary medicines<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/medical-devices\/register-of-medical-devices\/\">Register of medical devices<\/option>\n\t\t\t\t<\/select>\n\n\t\t\t\t<script type=\"text\/javascript\">\n\t\t\t\t\tfunction handleSelect(elm) {\n\t\t\t\t\t\twindow.location = elm.value;\n\t\t\t\t\t}\n\t\t\t\t<\/script>\n\t\t\t\t<img decoding=\"async\" style=\"top:22px;\" class=\"absolute right-[15px] top-[22px] \" src=\"\/wp-content\/uploads\/2022\/11\/strelca-copy-8.png\" \/>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n\t<img decoding=\"async\" class=\"absolute bottom-[30px] w-[380px]\" src=\"\/wp-content\/uploads\/2022\/11\/nele.png\" \/>\n<\/div>\n\n\n<div class=\"relative px-10 pt-10 mt-10 rounded pb-72 bg-light-yellow\">\n\t<div class=\"mt-8 md:mt-0\">\n\t\t<h1 class=\"text-3xl text-primary \">Sign up for<\/h1>\n\t\t<h1 class=\"mb-5 text-3xl font-bold text-primary\">Newsletter<\/h1>\n\t\t  \n  \n  <div class=\"\n    mailpoet_form_popup_overlay\n      \"><\/div>\n  <div\n    id=\"mailpoet_form_1\"\n    class=\"\n      mailpoet_form\n      mailpoet_form_shortcode\n      mailpoet_form_position_\n      mailpoet_form_animation_\n    \"\n      >\n\n    <style type=\"text\/css\">\n     #mailpoet_form_1 .mailpoet_form {  }\n#mailpoet_form_1 .mailpoet_column_with_background { padding: 10px; }\n#mailpoet_form_1 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       <\/p>\n        <p class=\"mailpoet_validate_error\"\n                style=\"display:none;\"\n                >        <\/p>\n      <\/div>\n    <\/form>\n\n      <\/div>\n\n  \t<\/div>\n\t<img decoding=\"async\" class=\"absolute bottom-0 left-0 w-[380px] \" src=\"\/wp-content\/uploads\/2022\/11\/newsletter.png\" \/>\n<\/div>\t\t<div class=\"elementor-shortcode\"><\/div>\n\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<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Medical devices Law on medical devices (\u201cOfficial Gazette of Montenegro\u201d, No. 024\/19) Law on administrative procedure (&#8220;Official Gazette of Montenegro&#8221; No 056\/14, 020\/15, 040\/16 and 037\/17) \u2013 document in Montenegrin; Note: this act is applied to all procedures initiated upon 1 July 2017 Rulebooks In accordance with the Law on Medical Devices (&#8220;Official Gazette of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7551,"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-7554","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical devices - Cinmed<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cinmed.me\/regulativa\/regulativa-medicinskih-sredstava\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical devices - Cinmed\" \/>\n<meta property=\"og:description\" content=\"Medical devices Law on medical devices (\u201cOfficial Gazette of Montenegro\u201d, No. 024\/19) Law on administrative procedure (&#8220;Official Gazette of Montenegro&#8221; No 056\/14, 020\/15, 040\/16 and 037\/17) \u2013 document in Montenegrin; Note: this act is applied to all procedures initiated upon 1 July 2017 Rulebooks In accordance with the Law on Medical Devices (&#8220;Official Gazette of [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/cinmed.me\/regulativa\/regulativa-medicinskih-sredstava\/\" \/>\n<meta property=\"og:site_name\" content=\"Cinmed\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-26T08:39:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/11\/Regulativa-medicinskih-sredstava.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"450\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" 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