{"id":222,"date":"2022-11-08T12:04:54","date_gmt":"2022-11-08T11:04:54","guid":{"rendered":"http:\/\/kvalitet.co.rs\/?page_id=222"},"modified":"2026-02-13T22:42:26","modified_gmt":"2026-02-13T21:42:26","slug":"potvrde-medicinska-sredstva","status":"publish","type":"page","link":"https:\/\/kvalitet.co.rs\/en\/potvrde-i-sertifikati\/potvrde-medicinska-sredstva\/","title":{"rendered":"Medical Devices"},"content":{"rendered":"<h3>Designation for conformity assessment of medical devices<\/h3>\n<p>Kvalitet a.d. is FIRST conformity assessment body\u00a0 designated by the Serbian Ministry of Health as a according to <a href=\"http:\/\/kvalitet.co.rs\/dokumenta\/zakoni\/medicinska-sredstva\/Pravilnik-medicinska-sredstva.pdf\">Rulebook on medical devices <\/a>(MDD):<\/p>\n<ul>\n<li><a href=\"http:\/\/kvalitet.co.rs\/dokumenta\/resenja\/Resenje-o-imenovanju-medicinska-sredstva.pdf\">Designation from Ministry of Health dated February 13th 2026.<\/a><\/li>\n<\/ul>\n<p>Our Scope of accreditation you can find <a href=\"http:\/\/kvalitet.co.rs\/dokumenta\/akreditacije\/04-001-Obim-akreditacije-vazeci.pdf\"><strong>here<\/strong><\/a> (in Serbian).<\/p>\n<p>Our accreditation scope includes next subgroups of products:<\/p>\n<ul>\n<li>MD 0105 Inactive ophthalmic agents <\/li>\n<li>MD 0106 Inactive instruments <\/li>\n<li>MD 0202 Inactive orthopedic implants<\/li>\n<li>MD 0301 Bandages and wound dressings<\/li>\n<li>MD 0402 Dental materials<\/li>\n<li>MD 0403 Dental implants<\/li>\n<li>MD 1102 Respiratory devices, including hyperbaric chamber devices for oxygen therapy, inhalation and anesthesia <\/li>\n<li>MD 1103 Devices for stimulation or inhibition <\/li>\n<li>MD 1104 Active surgical devices <\/li>\n<li>MD 1111 Software<\/li>\n<li>MD 1302 Devices for monitoring vital physiological parameters<\/li>\n<li>MD 1402 Devices using non-ionizing radiation <\/li>\n<li>MD 1403 Devices for hyperthermia\/hypothermia <\/li>\n<li>MDS 7006 Medical devices in sterile condition<\/li>\n<li>MDS 7009 Medical devices using biologically active coatings and\/or materials that are completely or partially absorbed<\/li>\n<\/ul>\n<h3>Application Forms<\/h3>\n<p>If you are interested in our medical certification services, please fill out the Questionnaire below and send it to us by email <a href=\"mailto:medicinskasredstva@kvalitet.co.rs\">medicinskasredstva@kvalitet.co.rs<\/a>.<\/p>\n<p>Please note that completing the Questionnaire is not a formal application, but merely a form of interest in our services.<\/p>\n<ul>\n<li><a href=\"http:\/\/kvalitet.co.rs\/dokumenta\/formulari\/medicinskasredstva\/UpitnikMDv1.6.docx\" target=\"_blank\" rel=\"noopener\">Questionnaire, request for quotation for evaluation of compliance of medical devices (in Serbian) <\/a><\/li>\n<\/ul>\n<h3 id=\"napomene\">The procedure for conformity assessment of medical devices<\/h3>\n<p>The procedure for conformity assessment of medical devices is given in the next documents (in serbian):<\/p>\n<ul>\n<li><a href=\"http:\/\/kvalitet.co.rs\/dokumenta\/pravilnici\/Pravilnik-za-ocenjivanje-usaglasenosti-proizvoda.pdf\" target=\"_blank\" rel=\"noopener\">Z00PR04 Rulebook for conformity assessment of products<\/a> <\/li>\n<li><a href=\"http:\/\/kvalitet.co.rs\/dokumenta\/formulari\/medicinskasredstva\/S03PC01.pdf\" target=\"_blank\" rel=\"noopener\">S03PC01 Conformity assessment with basic requirements for medical devices<\/a><\/li>\n<\/ul>\n<p>Instructions for using certification documents and for informing about changes<\/p>\n<p>Instructions for using the certification documents and for informing about the changes can be found in the following document:<\/p>\n<ul>\n<li><a href=\"http:\/\/kvalitet.co.rs\/dokumenta\/formulari\/medicinskasredstva\/S03UP02.pdf\" target=\"_blank\" rel=\"noopener\">S03UP02 Instructions for using certification documents and for informing about changes<\/a><\/li>\n<\/ul>\n<h3 id=\"napomene\">Register of issued and valid certificates of medical devices<\/h3>\n<ul>\n<li><a href=\"http:\/\/kvalitet.co.rs\/dokumenta\/formulari\/medicinskasredstva\/RegistarIzdatihSertifikataMSeng.pdf\" target=\"_blank\" rel=\"noopener\">Register of issued and valid certificates of medical devices <\/a><\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>Designation for conformity assessment of medical devices Kvalitet a.d. is FIRST conformity assessment body\u00a0 designated by the Serbian Ministry of Health as a according to Rulebook on medical devices (MDD): Designation from Ministry of Health dated February 13th 2026. Our Scope of accreditation you can find here (in Serbian). Our accreditation scope includes next subgroups [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":317,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-222","page","type-page","status-publish","hentry"],"translation":{"provider":"WPGlobus","version":"2.12.2","language":"en","enabled_languages":["sr","en"],"languages":{"sr":{"title":true,"content":true,"excerpt":false},"en":{"title":true,"content":true,"excerpt":false}}},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.1 (Yoast SEO v21.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Devices - \u041a\u0432\u0430\u043b\u0438\u0442\u0435\u0442 \u0430.\u0434. \u041d\u0438\u0448<\/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:\/\/kvalitet.co.rs\/potvrde-i-sertifikati\/potvrde-medicinska-sredstva\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Devices - \u041a\u0432\u0430\u043b\u0438\u0442\u0435\u0442\" \/>\n<meta property=\"og:url\" content=\"https:\/\/kvalitet.co.rs\/potvrde-i-sertifikati\/potvrde-medicinska-sredstva\/\" \/>\n<meta property=\"og:site_name\" content=\"\u041a\u0432\u0430\u043b\u0438\u0442\u0435\u0442\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-13T21:42:26+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/kvalitet.co.rs\/potvrde-i-sertifikati\/potvrde-medicinska-sredstva\/\",\"url\":\"https:\/\/kvalitet.co.rs\/potvrde-i-sertifikati\/potvrde-medicinska-sredstva\/\",\"name\":\"Medical Devices - \u041a\u0432\u0430\u043b\u0438\u0442\u0435\u0442 \u0430.\u0434. \u041d\u0438\u0448\",\"isPartOf\":{\"@id\":\"https:\/\/kvalitet.co.rs\/#website\"},\"datePublished\":\"2022-11-08T11:04:54+00:00\",\"dateModified\":\"2026-02-13T21:42:26+00:00\",\"description\":\"\u041a\u0432\u0430\u043b\u0438\u0442\u0435\u0442 \u0430.\u0434. \u041d\u0438\u0448 \u0458\u0435 \u043e\u0434 \u0441\u0442\u0440\u0430\u043d\u0435 \u041c\u0438\u043d\u0438\u0441\u0442\u0430\u0440\u0441\u0442\u0432\u0430 \u0437\u0434\u0440\u0430\u0432\u0459\u0430 8. \u0458\u0430\u043d\u0443\u0430\u0440\u0430 2020. \u0433\u043e\u0434\u0438\u043d\u0435 \u0438\u043c\u0435\u043d\u043e\u0432\u0430\u043d \u043a\u0430\u043e \u0442\u0435\u043b\u043e \u0437\u0430 \u043e\u0446\u0435\u045a\u0438\u0432\u0430\u045a\u0435 \u0443\u0441\u0430\u0433\u043b\u0430\u0448\u0435\u043d\u043e\u0441\u0442\u0438 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0430\u0432\u0430 ...\",\"breadcrumb\":{\"@id\":\"https:\/\/kvalitet.co.rs\/potvrde-i-sertifikati\/potvrde-medicinska-sredstva\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/kvalitet.co.rs\/potvrde-i-sertifikati\/potvrde-medicinska-sredstva\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/kvalitet.co.rs\/potvrde-i-sertifikati\/potvrde-medicinska-sredstva\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/kvalitet.co.rs\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Certificates and Confirmations\",\"item\":\"https:\/\/kvalitet.co.rs\/potvrde-i-sertifikati\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Medical Devices\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/kvalitet.co.rs\/#website\",\"url\":\"https:\/\/kvalitet.co.rs\/\",\"name\":\"\u041a\u0432\u0430\u043b\u0438\u0442\u0435\u0442\",\"description\":\"Kvalitet a.d. 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