Medical Device Registration in Turkey: Why a Foreign Manufacturer Cannot Register Alone
Updated: Aug 30
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.
Three routes, and what each one costs you
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.
Appoint a Turkish authorised representative
A representative established in Turkey registers as your authorised representative, holds the mandate, and files on your behalf. Your devices are registered under the mandate rather than under a commercial partner, and the registration does not move if you change distributor.
Under the EU–Türkiye Customs Union arrangement, an authorised representative may be nominated in Turkey or in the Union, and a single appointment covers both markets. For a manufacturer already appointing an EU authorised representative, this route adds Turkey without a second contract.
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.
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.
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
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.
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