{"id":7511,"date":"2022-11-24T14:08:59","date_gmt":"2022-11-24T14:08:59","guid":{"rendered":"https:\/\/cinmed.me\/medicinska-sredstva\/proizvodnja\/"},"modified":"2023-03-29T05:18:36","modified_gmt":"2023-03-29T05:18:36","slug":"manufacturing","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/medical-devices\/manufacturing\/","title":{"rendered":"Manufacturing"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7511\" class=\"elementor elementor-7511 elementor-1612\" 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=\"840\" height=\"420\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-840x420-1.jpg\" class=\"attachment-large size-large wp-image-4557\" alt=\"Proizvodnja medicinskih sredstava\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-840x420-1.jpg 840w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-840x420-1-300x150.jpg 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-840x420-1-768x384.jpg 768w\" sizes=\"(max-width: 840px) 100vw, 840px\" \/>\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-8ab3f95 elementor-widget elementor-widget-text-editor\" data-id=\"8ab3f95\" 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>Manufacturing of medical devices may be carried out only by registered legal and natural persons, in accordance with the Law on medical devices.<\/p><p>\u00a0<\/p><p>Manufacturing of medical devices shall include the design, manufacturing, packaging and labeling, quality assurance system, storage, placing on the market and distribution of medical devices. The activity of the manufacturing of medical devices also include the sale of these products to legal entities that carry out wholesale of medical devices.<\/p><p>\u00a0<\/p><p>Registration of the manufacturer shall not be required for legal and natural persons who assemble or adapt medicinal devices of a specific intended purpose that are already on the market and are intended for a particular patient.<\/p><p>\u00a0<\/p><p>Manufacturing of medical devices shall be carried out in accordance with the established system of quality assurance of the medical device manufacturing, proven by the manufacturer by way of a certificate issued by the certified body.<\/p><p>Manufacturer shall manufacture medical devices in accordance with the essential requirements and the decision issued by the Institute. Manufacturer shall provide insurance against harmful effects that may arise when using a medical device, in accordance with the Insurance Law.<\/p><p>\u00a0<\/p><p>Manufacturer\u2019s registration may refer to the entire process or parts of the process of a medical device manufacture. The decision on the manufacturer\u2019s registration shall be issued for an indefinite period.<\/p><p>\u00a0<\/p><p>Manufacturer shall continuously supply the market with medical devices from its program in accordance with the decision on the registration of medical devices.<\/p><p>\u00a0<\/p><p>\u00a0Manufacturer must meet special conditions, as follows:<\/p><ul><li>to provide conditions in terms of space and equipment for the manufacturing of medical devices, in accordance with the essential requirements for the medical device whose manufacture he performs;<\/li><li>to have at least one employee responsible for manufacture;<\/li><li>to have at least one person responsible for quality and vigilance;<\/li><li>to ensure that the medical device is designed in accordance with the essential requirements;<\/li><li>to classify the medical device in the appropriate risk class, prepare the prescribed technical documentation and implement, or ensure the implementation of the applicable conformity assessment procedure;<\/li><li>to issue a declaration of conformity, where applicable, and mark the medical device with a marking of conformity in accordance with the Law;<\/li><li>to keep the technical documentation and the declaration of conformity after placing the medical device on the market for at least five years, and for implantable medical devices for at least 15 years;<\/li><li>to have in place the procedures ensuring the maintenance of conformity of the medical device manufacture with the essential requirements and technical standards;<\/li><li>to label the medical device and attach the instructions for use in accordance with the Law;<\/li><li>to take the necessary corrective measures in the event of established non-conformity;<\/li><li>for a medical device, except for a custom-made medical device or investigational medical device, to establish and maintain, and to keep proper records of non-compliant medical devices and those withdrawn from the market;<\/li><li>to have a plan for the withdrawal of a medical device from the market;<\/li><li>to keep records on the type and quantity of sold medical devices in Montenegro; <\/li><li>to provide other conditions for the manufacture in accordance with the Law<\/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-e1caf8c elementor-widget elementor-widget-heading\" data-id=\"e1caf8c\" 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\">Instructions and forms<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b6e1152 elementor-widget elementor-widget-text-editor\" data-id=\"b6e1152\" 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=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/03\/INSTRUCTION-FOR-APPLICANTS-FOR-THE-REGISTRATION-OF-MANUFACTURERS-OF-MEDICAL-DEVICES-THAT-DO-NOT-HAVE-SEAT-RESIDENCE-IN-MONTENEGRO-.pdf\" target=\"_blank\" rel=\"noopener\">Instruction for applicants for the registration of manufacturers of medical devices that do not have seat-residence in Montenegro<\/a> (<em>updated on March 24, 2023<\/em>)<\/li><li><a href=\"\/wp-content\/uploads\/2022\/11\/Za851.69-03-IMS-Zahtjev-za-registraciju-izmjenu-registracije-brisanje-iz-registra-proizvo_a_a-medicinskih-sredstava-koji-nemaju-sjedi_te-boravak-prebivali_te-u-CG.docx\" target=\"_blank\" rel=\"noopener\">Application form for registration\/amendment to registration\/removal from the register of manufacturers that do not have seat-residence in Montenegro<\/a> <em>(updated on December 1, 2021) \u2013 <\/em>document in Montenegrin<\/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-d7285c8 elementor-widget elementor-widget-heading\" data-id=\"d7285c8\" 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\">Register of manufacturers of 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-20b630d elementor-widget elementor-widget-text-editor\" data-id=\"20b630d\" 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><strong>Decision on the registration for medical devices manufacturing in Montenegro has been issued to following manufacturers (updated: 08.06.2020.)<\/strong><strong>:<\/strong><\/p><p><b>\u00a0<\/b><\/p><hr \/><p><b>Hemomont d.o.o., Podgorica<\/b><br \/>address: Ilije Plamenca b.b.<br \/>tel: +382 20 662 300<\/p><p>\u00a0<\/p><p>for following medical devices of class IIa:<br \/>&#8211; lubricant eye drops<\/p><p>\u00a0<\/p><p>for following medical devices of class IIb:<br \/>&#8211; sterile nasal spray<\/p><p>\u00a0<\/p><hr \/><p><b>Rudo Montenegro d.o.o., Podgorica<\/b><br \/>address: Bul. Crnogorskih serdara b.b.<br \/>tel: +382 20 624 448<\/p><p>\u00a0<\/p><p>for following medical devices of class I, custom-made, for a particular patient:<\/p><p>-prostheses for lower extremities<br \/>-prostheses for upper extremities<br \/>-apparatuses for upper and lower extremities<br \/>-spinal orthosis<br \/>-orthoses for upper and lower extremities (longuette)<br \/>-orthopedic shoes<br \/>-anatomical insoles.<\/p><p>\u00a0<\/p><hr \/><p><b>Spark d.o.o., Nik\u0161i\u0107<\/b><\/p><p>address: Serdara \u0160\u0107epana b.b.<br \/>tel: +382 40 242 135, fax 242 096<\/p><p>\u00a0<\/p><p>for following medical devices of class I:<\/p><p>-surgical gown<br \/>-surgical uniform<br \/>-surgical sheet with and without slots<br \/>-surgical compress<\/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-ceecb70 elementor-widget elementor-widget-heading\" data-id=\"ceecb70\" 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\">Register of manufacturers of medical devices that do not have seat\/residence in Montenegro <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-845b3fa elementor-widget elementor-widget-text-editor\" data-id=\"845b3fa\" 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><em>Page is under construction<\/em><\/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-937c37e elementor-widget elementor-widget-shortcode\" data-id=\"937c37e\" 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=\"sidebar-menu-wrapper\">\r\n        <div class=\"sidebar-menu-header\">\r\n            <img decoding=\"async\" class=\"sidebar-menu-header-icon\" src=\"\/wp-content\/uploads\/2022\/11\/3.png\" \/>\r\n            <P><a class=\"sidebar-menu-header-title\" href=\"\">Medical devices<\/a><\/P>\r\n        <\/div>\r\n        <div class=\"sidebar-items-background\">\r\n            <div class=\"sidebar-items-wrapper\">\r\n                <div class=\"menu-medicinska-sredstva-container\"><ul id=\"menu-medicinska-sredstva\" class=\"list-none\t\"><li id=\"menu-item-7267\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7267 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/registracija\/\">Registration<\/a><\/li>\n<li id=\"menu-item-7268\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7268 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/promet-na-veliko\/\">Wholesale of medical devices<\/a><\/li>\n<li id=\"menu-item-15734\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-15734 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/interventni-uvoz\/\">Emergency import<\/a><\/li>\n<li id=\"menu-item-7269\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7269 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/promet-na-malo\/\">Retail sale of medical devices<\/a><\/li>\n<li id=\"menu-item-7270\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7270 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/proizvodnja\/\">Manufacturing<\/a><\/li>\n<li id=\"menu-item-15733\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-15733 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/registracija-proizvodaca-medicinskih-sredstava-koji-nemaju-sjediste-boravak-prebivaliste-u-crnoj-gori\/\">Registration of manufacturers of medical devices that do not their have headquarters\/temporary-permanent residence in Montenegro<\/a><\/li>\n<li id=\"menu-item-7271\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7271 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/oglasavanje\/\">Advertising<\/a><\/li>\n<li id=\"menu-item-7272\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7272 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/obiljezavanje\/\">Labelling<\/a><\/li>\n<li id=\"menu-item-7266\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7266 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/viliganca\/\">Vigilance<\/a><\/li>\n<li id=\"menu-item-7273\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7273 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/klinicko-ispitivanje\/\">Clinical investigation<\/a><\/li>\n<li id=\"menu-item-7276\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7276 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/registar-medicinskih-sredstava\/\">Register of medical devices<\/a><\/li>\n<\/ul><\/div>            <\/div>\r\n        <\/div>\r\n    <\/div>\r\n\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<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      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{#mailpoet_form_1 .mailpoet_form_column:last-child .mailpoet_paragraph:last-child {margin-bottom: 0}} \n    <\/style>\n\n    <form\n      target=\"_self\"\n      method=\"post\"\n      action=\"https:\/\/cinmed.me\/wp-admin\/admin-post.php?action=mailpoet_subscription_form\"\n      class=\"mailpoet_form mailpoet_form_form mailpoet_form_shortcode\"\n      novalidate\n      data-delay=\"\"\n      data-exit-intent-enabled=\"\"\n      data-font-family=\"\"\n      data-cookie-expiration-time=\"\"\n    >\n      <input type=\"hidden\" name=\"data[form_id]\" value=\"1\" \/>\n      <input type=\"hidden\" name=\"token\" value=\"59e8bb3825\" \/>\n      <input type=\"hidden\" name=\"api_version\" value=\"v1\" \/>\n      <input type=\"hidden\" name=\"endpoint\" value=\"subscribers\" \/>\n      <input type=\"hidden\" name=\"mailpoet_method\" value=\"subscribe\" \/>\n\n      <label class=\"mailpoet_hp_email_label\" style=\"display: none !important;\">Please leave this field empty<input type=\"email\" 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class=\"mailpoet_bounce2\"><\/span><span class=\"mailpoet_bounce3\"><\/span><\/span><\/div>\n\n      <div class=\"mailpoet_message\">\n        <p class=\"mailpoet_validate_success\"\n                style=\"display:none;\"\n                >Thank you for subscribing!\n        <\/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>Manufacturing of medical devices may be carried out only by registered legal and natural persons, in accordance with the Law on medical devices. \u00a0 Manufacturing of medical devices shall include the design, manufacturing, packaging and labeling, quality assurance system, storage, placing on the market and distribution of medical devices. The activity of the manufacturing of [&hellip;]<\/p>\n","protected":false},"author":1,"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-7511","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>Manufacturing - Cinmed<\/title>\n<meta name=\"description\" content=\"Register of manufacturers of medical devicesRegister of manufacturers of medical devices that do not have seat\/residence in Montenegro\" \/>\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\/en\/medical-devices\/manufacturing\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Manufacturing - 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