Regulatory services Turkey
Since 1995, a customs union has been in place between Turkey and the EU. It does not only mean that products can flow freely in case they are produced in either the EU or Turkey.
It also resulted in alignment of (regulatory) frameworks. Both the customs union and the alignment with EU MDR and IVDR (since 2021) have made it easier to market medical devices in the Turkish market.
Simplifications due to alignment
As mentioned, Turkish medical device and IVD regulations have been reconciled with the existing EU frameworks (MDR, IVDR) under the guidance of the Turkish medicines and medical device agency (TITCK). CE marking of products is required and enough to commercialize products in Turkey. No additional conformity assessment is needed.
Several other documents like EC certificate, DoC documents and Design Examination Certificate are also required depending on the classification of the products.
The procedure for obtaining the CE Mark may differ depending on the risk class of medical devices according to Article 52 of Regulation (EU) 2017/745. Article 52 of Regulation (EU) 2017/745.For Class I medical devices other than custom-made or investigational devices, manufacturers can declare their compliance with the MDR requirements by issuing an EU declaration of conformity (article 19, MDR) and independently proceed with the CE Mark. For Class I sterile devices (Is) or surgical instruments with measuring function (Im) or reusable ones (Ir), IIa, IIb and III (including custom-made implantable devices), the intervention of the Notified Body is always required.
In order to distribute, import and sell medical devices in Turkey, it is necessary to have a local medical device sales center license in Turkey. Manufacturers that have no local presence in Turkey must appoint a local Authorized Representative (AR) who is responsible for the registration and becomes the license holder (LH). The owner of the registration is the Local Authorized Representative.
Finally, customs restrictions are eliminated. EUDAMED (the European Database on Medical Devices) registration of devices and vigilance notifications do apply to Turkey as well. Usage of the Turkish database is not anymore required for this.
In order to sell devices and issue devices in Turkey, it is mandatory to register the products in the UTS system in Turkey.
Additional requirements
Despite the alignment between the EU and Turkey regulatory framework, specific requirements exist in case a manufacturer wants to commercialize their products in Turkey:
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Device registration: only those devices that are registered in the Turkish Product Tracking System (ÜTS or TITUBB, Turkish Drug and Medical Device National Databank) can be commercialized in Turkey (in line with article 14 of the Turkish regulation). Until EUDAMED is fully operational, this article will remain leading (after a so-called transition period, EUDAMED registration is required);
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Article 34 of the Turkish MDR states that registration of a Turkish importer is required. They must be based in Turkey and registered in ÜTS;
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Sales of medical devices and IVD in Turkey can only take place through sales centers that are authorized by the Turkish department of health. This applies as well to advertising and sales promotion activities. These sales centers need staff and an appointed competent person, trained by the department of health. Apart from low-risk devices (which may be sold as well through unauthorized outlets), medical devices may only be sold through authorized sales centers;
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As far as advertising of devices is concerned, the rule is that devices may not be advertised that may be sold only through the authorized sales centers, are generally available on prescription and are intended only for professional usage;
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Relevant information (for instance the IFU) accompanying medical devices and IVD must be provided in the Turkish language.
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Classification
Product classification basically follows the EU. This means medical devices are classified as I, IIa, IIb and III respectively. IVDs belong either to an A, B, C or D class dependent on the risk.
Timeframe
UTS product registration takes place within 1-2 months after all apostilled documents and documents such as labels, images, IFU etc. are provided to the local representative.
License validity
The license expires when the CE certificate and the Design Examination Certificate, which may be required depending on the product class, expires.
Medical device categories that cannot be registered, sold, tracked or reported with only CE marking
It is necessary to provide an EC certificate obtained under the MDR (+ Design Examination Certificate for high-risk products) and DoC documents. These documents and products must be registered in the TITCK Product Tracking System (UTS). Medical devices registered in the UTS system can be monitored for import, sale, tracking, and reporting through the system.
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Medical device manufacturers who do not yet hold an EC certificate under Regulation (EU) 2017/745 (MDR):
If these manufacturers have applied to an approved body under Regulation (EU) 2017/745 (MDR) before 26 May 2024 and have signed a contract with this approved body before 26 September 2024, they can extend the validity period of their current certificates (Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD)) through local Authorized Representatives via the TITCK EYS system and the UTS system. The extension periods for each product class are specified below:
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26 May 2026 for Class III custom-made implantable devices
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31 December 2027 for Class III devices and Class IIb implantable devices excluding Well-established technologies (WET) such as sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors
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31 December 2028 for other Class IIb devices, Class IIa devices, and Class I devices placed on the market in sterile condition or with a measuring function
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31 December 2028 for devices that do not require the involvement of a notified body under MDD but do under MDR (e.g., Class I devices qualifying as reusable surgical instruments)
