Update on the Medical Devices Regulations in Turkey

All kinds of manufacturing, marketing, and after-sales activities of medical devices are highly regulated in Turkey. The main framework for ensuring safety and compliance with the technical specifications is governed by the Law on Product Safety and Technical Specifications No. 7,223, which is an umbrella legislation covering all products intended to be placed on the market, supplied, or placed on the Turkish market.

Further to above, general rules and principles of medical devices are provided in Regulation on Medical Devices (“Regulation”) and Regulation on Medical Devices for In Vitro Diagnosis (“IVD Regulation”) which have been prepared in full harmony with European Medical Device Regulation numbered 2017/745 (“MDR”) and In Vitro Diagnostic Medical Device Regulation numbered 2017/746 (“IVDR”), respectively, in line with Turkey’s aim of full harmonization with the EU regulations.

Subsequently, amendments to Regulation (EU) No 2023/607 of the European Parliament and of the Council of 20 March 2023 and Regulation (EU) No 2024/1860 of the European Parliament and of the Council of 9 July 2024, aimed at reducing the risk of non-supply in the field of medical devices, were reflected in the Regulation and the IVD Regulation on 2 April 2023 and 17 August 2024 respectively. In other words, Turkish medical device legislation is almost fully in line with the EU medical device regulation, except for a few additional requirements in registration and sales of medical devices.

Besides the Law and regulations described above, there is also a specific regulation on advertisement and promotion activities of medical devices in Turkey, which is the Regulation on Sales, Advertisement, and Promotion of the Medical Devices (“Promotion Regulation”).

The Promotion Regulation requires that a medical device bearing the CE mark must be registered with the Product Tracking System (“ÜTS”) of the Ministry of Health to be placed in the Turkish market. No medical device can be marketed in Turkey without being registered on the ÜTS. The registration must be made by a Turkish entity placing the medical device on the Turkish market, such as a manufacturer, an affiliate, a distributor, or a local partner that is established in Turkey.

Additionally, only entities that are established in Turkey and authorized by the Ministry of Health as a medical device sales center may sell medical devices. In other words, foreign companies cannot directly launch their products to the market since the Promotion Regulation requires medical device sales centers to be established in Turkey. Therefore, foreign entities need a local distributor, which will be authorized as a medical device sales center to register and market their medical devices in Turkey.

Violation of the Promotion Regulation by conducting sales, advertisement, and promotion activities without obtaining an authorization certificate and/or failure to register products with the ÜTS may result in facing sanctions. The Ministry of Health’s Medicines and Medical Devices Agency is authorized to impose an administrative fine and/or order cease of activity upon determination of conducting marketing activities without obtaining an authorization certificate from the Ministry of Health as a medical device sale center by an inspection that is conducted either ex officio or upon complaint of third parties.

First published by Legal Industries Review Türkiye Edition 6 N°2 in Sep 04, 2024.