Medical Device Registration in Turkey: Why a Foreign Manufacturer Cannot Register Alone
Updated: Oct 20
A manufacturer established outside Turkey cannot place a medical device on the Turkish market by filing the paperwork itself. This is not a policy preference or a service being sold — it is a structural feature of how medical device registration in Turkey works, and it catches almost every manufacturer approaching the market for the first time.
Why medical device registration in Turkey has two stages
The system has two stages, and the first one blocks you
ÜTS, the Product Tracking System operated by the Turkish Medicines and Medical Devices Agency, separates registration into company registration and product registration. Product registration cannot begin until company registration is complete.
Company registration requires a Turkish tax number, a MERSİS record confirming the company exists in the Turkish trade registry, and a qualified electronic signature belonging to an authorised person. None of these are available to an entity that has no legal presence in Turkey.
So the obstacle is not the device file. It is the identity of the filer.
How a foreign manufacturer can sell medical devices in Turkey: three routes
Establish a Turkish subsidiary
A company incorporated in Turkey obtains a tax number and MERSİS record as a matter of course, and can register as manufacturer, importer or distributor in ÜTS. This gives you full control and no dependency on a third party. It also gives you a Turkish corporate entity with its own accounting, tax filings and responsible manager obligations.
This is the right answer for manufacturers with meaningful Turkish revenue. It is a heavy answer for a manufacturer testing the market.
Appoint a Turkish importer or distributor
The importer registers itself in ÜTS and registers your devices under its own record. This is the fastest route and requires no investment from you.
It also means your market access sits inside a commercial relationship. If the distributor is replaced, the registrations move. Manufacturers who have been through a distributor change once rarely want to be in that position again.
Register under a licensed Turkish registration holder
Your devices are registered in ÜTS under a Turkish company that holds a medical device sales centre licence and an ÜTS firm record but does not import. The registration holder then grants ÜTS import notification rights to each importer you choose. TİTCK's guide on single-movement notifications (Article 7) states that an import notification may be made by the importer and also by a dealer the importer has authorised.
This is how you sell medical devices in Turkey through several importers at once. When you change distributor, the registrations stay where they are; only the import authorisation moves to the new company.
What you sign is a letter of authorisation naming the registration holder. In ÜTS it is filed as an authorised distributor certificate. The ÜTS registration guide (TCKKD-KLVZ-03, Article 23) lists what it must contain: the manufacturer's name and address, the authorised company, the product scope, the start date and any end date, and the manufacturer's signature and stamp. Exclusivity is not on that list, and you decide the term.
Each importer still needs its own sales centre licence and ÜTS firm record (the guide requires both for importer and dealer firm types, Article 5), its own TAREKS user for customs clearance, and its own name and address on the device or its packaging (Article 13(3) of the Turkish Medical Device Regulation).
Medex acts as registration holder in this model and, on request, as your authorised representative too. See ÜTS registration consultancy for Türkiye.
The authorised representative is a separate requirement
If you are established outside the EU and Türkiye, you need an authorised representative whichever route you choose. Under the EU-Türkiye Customs Union arrangement the authorised representative may be established in Turkey or in the Union, and a single appointment covers both markets.
The authorised representative does not hold your ÜTS registration. The registration sits with the Turkish company whose account it is filed under. The mandate is uploaded to ÜTS together with the declaration of conformity, as described below. See EU authorised representative and Türkiye.
Medex is registered in EUDAMED as an authorised representative (SRN TR-AR-000057550). If you need one, we can take on that role as well, so the ÜTS registration and the authorised representative mandate sit with one company and you deal with a single contact for both. See our EU authorised representative service and pricing.
What is filed once the company record exists
Product registration requires the CE certificate where a notified body is involved, the EU declaration of conformity, product catalogue and label information, EMDN codes and UDI-DI data for each variant. The declaration of conformity is the document that most often causes a file to come back — its content must match the record being created. The full document set a foreign manufacturer should prepare is listed in our note on ÜTS registration for foreign manufacturers.
Registrations also have to be kept current. Changes to the responsible manager, to certificates or to the device itself are notified events, not optional updates.
A point worth stating plainly
Turkish registration obligations do not sit with the local partner alone. Where a manufacturer is established abroad, the importer or distributor carries obligations in parallel — appointing a local partner does not transfer your responsibility for the device, and it does not make the declaration of conformity someone else's document. Only the manufacturer draws up the declaration of conformity.
Beyond the two registration stages, five practical points decide whether a Turkish file goes through without findings.
The legal basis: MDR and IVDR in Turkish law
Türkiye does not run a separate national approval regime for medical devices. Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) were carried into Turkish law as the Tıbbi Cihaz Yönetmeliği (Medical Device Regulation) and the İn Vitro Tanı Amaçlı Tıbbi Cihaz Yönetmeliği (In Vitro Diagnostic Medical Device Regulation), both published in the Resmî Gazete of 2 June 2021, issue 31499 (mükerrer). The device regulation applies from 26 May 2021 and the IVD regulation from 26 May 2022, the same dates as in the Union. Both were amended by a regulation published in the Resmî Gazete of 29 July 2022, issue 31907. TİTCK is the competent authority.
The link to the EU is the EU-Türkiye Customs Union. In its Notice to Stakeholders on the EU-Türkiye Customs Union Agreement in the field of medical devices (March 2022, published on the Commission's health portal on 13 April 2022), the Commission records that the Customs Union Joint Committee confirmed, in statements of 21 May 2021 and 13 September 2021, that Turkish legislation is aligned with the MDR and the IVDR. The notice also states that a notified body established in Türkiye has the same rights and obligations as one established in the EU, and that certificates issued on either side are valid on the other.
So a device lawfully CE marked under the MDR or IVDR can be placed on the Turkish market without a second conformity assessment. What it still needs is a Turkish registration in ÜTS. The full Customs Union chain of instruments is set out in our note on the Customs Union basis for a Türkiye-based authorised representative.
Turkish-language labels and IFU
MDR Article 10(11) requires the information supplied with the device to be in the official language determined by the country where it is made available to the user or patient. In Türkiye that language is Turkish, and ÜTS registration guidance expects a Turkish label to be uploaded where the original label is not in Turkish. The Turkish text has to match the device and the documents: model names, reference numbers and the CE marking with notified body number should be the same on the label, the IFU, the declaration and the ÜTS entry.
A common cause of findings is a label or product image that shows other models or barcodes that are not part of the registration. Keep each uploaded label specific to the registered device. Wider EU language rules are covered in our note on label language requirements.
Sworn translation and apostille
TİTCK's ÜTS registration guide (TCKKD-KLVZ-03) sets out how a foreign manufacturer's documents are accepted. The EU declaration of conformity and the notified body certificate are uploaded with an apostille, consular legalisation, an e-Apostille or a verifiable electronic signature (Articles 8 and 12). A letter of authorisation follows the same routes (Article 23(4)). The authorised representative mandate is the exception: the original is uploaded with a sworn Turkish translation, and no apostille or consular legalisation is required (Article 12(7)(c)).
Every document that is not in Turkish is uploaded together with a translation by a Turkish sworn translator. Medex holds a sworn translator registration and prepares these translations in-house.
The sales centre authorisation for the Turkish distributor
A Turkish company that sells medical devices must hold a medical device sales centre authorisation certificate (Tıbbi Cihaz Satış Merkezi yetki belgesi) under the Tıbbi Cihaz Satış, Reklam ve Tanıtım Yönetmeliği (Medical Device Sales, Advertising and Promotion Regulation). The application is handled through the provincial health authorities and requires, among other things, suitable premises and qualified staff, including a responsible manager and sales and promotion personnel.
This is a requirement for the Turkish company, not for the foreign manufacturer. When you assess an importer, ask to see its sales centre authorisation and its ÜTS firm record before you sign the distribution agreement.
Import clearance: TAREKS
ÜTS registration does not clear goods through customs on its own. Under the Turkish Communiqué on the Import Inspection of Medical Devices (2026/16), all import inspection of medical devices is handled through TAREKS, the risk-based control system of the Ministry of Trade, and a company that wants to import must be defined in TAREKS with at least one authorised user (Article 4). The documents uploaded for each consignment include the EU declaration of conformity and notified body certificates with certified Turkish translations, and the Turkish label and instructions for use (Annex 2).
The TAREKS application is made by the company that actually imports the consignment. In the registration-holder model described above, that is the importer you authorised, not the registration holder.
After registration: ÜTS movement notifications
ÜTS is a tracking system, not only a register. After a device is registered, its movements are notified in the system. TİTCK publishes a separate guide on these single-movement notifications (Tıbbi Cihazların Ürün Takip Sistemi Tekil Hareket Bildirimlerine İlişkin Kılavuz). In practice this covers:
Import notifications, made by the importer when devices enter Türkiye, with the country of import and customs tariff data.
Transfer notifications, made when devices are given to another company and accepted by the receiving company.
Notifications of delivery to health institutions or end users, where the device group requires them.
Notifications only work if the product records are correct.
If your company is established in Türkiye and needs help with firm, document and product registration and notifications, see our ÜTS registration consultancy for Türkiye. Foreign manufacturers can also read our note on ÜTS registration for foreign manufacturers and the EU authorised representative and Türkiye page.
A Turkish-language version of this guide, with the regulatory text quoted in full, is available on our Turkish site: yabancı üretici Türkiye satış modelleri.
Sources
Tıbbi Cihaz Yönetmeliği, Resmî Gazete 2 June 2021, No 31499 (repeated issue)
Türkiye İlaç ve Tıbbi Cihaz Kurumu — ÜTS registration guidance
Decision No 1/2006 of the EC–Türkiye Association Council
Notice to Stakeholders — EU-Türkiye Customs Union in the field of medical devices, European Commission, March 2022
TİTCK, Tıbbi Cihazların Ürün Takip Sistemine Kayıt Süreçlerine İlişkin Kılavuz (TCKKD-KLVZ-03), 13 May 2026, Articles 5, 12 and 23
TİTCK, Tıbbi Cihazların Ürün Takip Sistemi Tekil Hareket Bildirimlerine İlişkin Kılavuz, Article 7
Tıbbi Cihazların İthalat Denetimi Tebliği (Ürün Güvenliği ve Denetimi: 2026/16), Article 4 and Annex 2
Who wrote this
Medex is established in Ankara, registered in EUDAMED as an authorised representative under SRN TR-AR-000057550, and registered with the Turkish Medicines and Medical Devices Agency. We are not a law firm and do not provide legal advice. Send us your device list and we will respond in writing.
Medex is the local legal entity for manufacturers entering the Turkish market, and under the EU–Türkiye Customs Union a single authorised representative appointment covers both markets.The Turkish side of the process — ÜTS company, document and product registration — is handled by our Turkish practice. Step-by-step guidance in Turkish is available on medexmedikal.com ÜTS registration guide.
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