{"id":20942,"date":"2022-05-30T14:04:38","date_gmt":"2022-05-30T12:04:38","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=20942"},"modified":"2022-05-30T14:04:38","modified_gmt":"2022-05-30T12:04:38","slug":"turkey-customs-union-agreement-to-market-medical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/05\/30\/turkey-customs-union-agreement-to-market-medical-devices\/","title":{"rendered":"TURKEY: Customs Union Agreement to market medical devices"},"content":{"rendered":"\n<p>On 13 April 2022, the European Commission\npublished the notice (<em>Notice To Stakeholders<\/em>) <strong>to regulate trade\nrelations between Turkey and the European Union<\/strong> and ratify the provisions\nof the <strong>Customs Union Agreement.<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/05\/turchia-ue-customs-union-agreement-1024x536.jpg\" alt=\"TURKEY: Customs Union Agreement to market medical device\" class=\"wp-image-20925\"\/><figcaption>TURKEY: Customs Union Agreement to market medical device<\/figcaption><\/figure>\n\n\n\n<p>Turkey, not being an EU member state, needs a\ncustoms union agreement to remove trade barriers and ensure the free movement\nof medical devices and in vitro diagnostic devices in the European Union.<\/p>\n\n\n\n<p>The\nestablishment of the Customs Union took place gradually and the alignment of\nTurkish legislation to the MDR (EU) 2017\/745 and the IVDR (EU) 2017\/746 was\nconfirmed by the EU-Turkey Customs Union Committee by the declarations of 21\nMay 2021 and 13 September 2021.<\/p>\n\n\n\n<p>With the\nnotice of last April, additional requirements regarding, for example<strong>, the\nappointment of the Authorized Representative<\/strong> and <strong>the certifications\nissued by the Notified Bodies,<\/strong> have been made official.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What is the impact for companies?<\/strong><\/h2>\n\n\n\n<p>The Notice To Stakeholders focuses\non two main aspects of the Customs Union Agreement between the European Union\nand Turkey:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Appointment of an Authorised Representative <\/strong><\/li><\/ul>\n\n\n\n<p><strong>Manufacturers based in Turkey <\/strong>are not required to appoint a\nEuropean Authorised Representative to market their devices in the EU;as\nwell as<strong> Manufacturers based in the European Union <\/strong>are not required to\nappoint an Authorized Representative in Turkey to export their devices in the\nTurkish market.With regard to<strong> Manufacturers located outside both\nTurkey and the EU, <\/strong>in order to place their DM or IVD on the market in these\ntwo territories, they shall appoint an Authorized Representative in Turkey<strong>\nor <\/strong>in Europe.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Notified bodies<\/strong><\/li><\/ul>\n\n\n\n<p>Turkey is authorised to designate\nNotified Bodies in accordance with EU Regulations 2017\/745 and 2017\/746; it\nfollows that Notified Bodies established in Turkey have the same rights and\nobligations as NBs established in the EU. The Notice To Stakeholders published\nby the European Commission confirms that medical devices and IVDs covered by a\ncertificate duly issued by a Turkish Notified Body, can circulate freely in the\nEuropean Union, and also states that DM and IVD certified by a Notified Body\nbased in the EU can move freely in Turkey.<\/p>\n\n\n\n<p>Thanks to agreements with the\nEuropean Union, the marketing of medical devices and IVDs in Turkey is\ncertainly facilitated. This does not mean, however, that there are no further <strong>pre-market\nregulatory requirements<\/strong> to place devices on the territory. We would like to\nrecall, for example, that all medical devices and IVDs must be registered in\nthe <strong>online database of the Turkish Ministry<\/strong> (TITUBB, Turkish Drug and\nMedical Device National Databank) in order to be sold in Turkey.<\/p>\n\n\n\n<p><strong>&gt;&gt;&gt; Do you need support to market your\ndevices in Turkey?<\/strong><\/p>\n\n\n\n<p>Rely on Thema experts for a <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\"><strong>strategic-regulatory consulting<\/strong><\/a>. Thanks to a constant professional\nupdate, Thema professionals will allow you to access the market in a faster and\nmore competitive way.<\/p>\n\n\n\n<p><strong>&gt;&gt;&gt; Are you a Manufacturer based\noutside the EU and Turkey and want to export your devices to these territories?\n<\/strong><\/p>\n\n\n\n<p>Choose Thema as your <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/european-authorised-representative-service\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"European Authorized Representative (si apre in una nuova scheda)\">European Authorized Representative<\/a><\/strong> and you will be independent in the regulatory process: in case of interruption of the relationship with your Distributor you will not have to worry about any obstacle to the sale of your devices and your business opportunities will increase.<\/p>\n\n\n\n<p><a href=\"mailto:sales@thema-med.com\"><strong>Contact our Customer Service <\/strong><\/a>for more information on our services!<\/p>\n\n\n\n<p><em>Source:<\/em><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/latest-updates\/notice-stakeholders-eu-turkey-customs-union-agreement-field-medical-devices-2022-04-13_en\">Notice to stakeholders. EU-Turkey\nCustoms Union Agreement in the field of medical device, European Commission, 13\naprile 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 13 April 2022, the European Commission published the notice (Notice To Stakeholders) to regulate trade relations between Turkey and the  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-20942","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>TURKEY: Customs Union Agreement to market medical 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