ÜTS registration: which documents need a Turkish translation
Before a medical device or IVD can be sold in Türkiye, the device and the companies that handle it have to be registered in ÜTS, the national product tracking system run by TİTCK. For an imported device, most of the paperwork behind that record comes from the manufacturer, in English, and a good part of it has to go in with a Turkish translation. This guide sets out which documents those are, what TİTCK asks for, and where registrations usually stall.
In short
- ÜTS (Ürün Takip Sistemi) is the register for medical devices and economic operators in Türkiye. It also tracks each unit through the supply chain.
- A manufacturer outside Türkiye does not make the record itself. A firm registered in Türkiye, usually the importer, does, with the manufacturer's documents.
- Under TİTCK announcement 2022/KK-1, foreign documents such as the declaration of conformity, the ISO 13485 certificate and the authorised distributor letter are uploaded with a sworn Turkish translation, and most need an apostille or consular legalisation.
- The instructions for use are uploaded twice: the current original from the technical file and its Turkish version.
- Since 13 May 2026, registration follows TİTCK's new ÜTS registration guide (TCKKD-KLVZ-03).
What ÜTS is
The Turkish Medical Device Regulation follows the EU MDR, including its rules on unique device identification (Article 27) and on registering devices and economic operators (Articles 29 and 31). ÜTS is where Türkiye carries those obligations out. It holds the records of manufacturers, importers, distributors and authorised representatives, and a record for each device, keyed to its barcode (UDI-DI).
ÜTS also tracks units after registration. Production or import, each transfer between companies, use on a patient, export and recall are notified to the system by serial or lot number. A device that is not registered cannot move through that chain, and public hospitals and SGK reimbursement rely on the ÜTS record.
Who makes the record
ÜTS accounts belong to firms registered in Türkiye, through their MERSİS or tax records, and applications are signed by the firm's authorised signatories. For an imported device, the record is normally made by the Turkish importer. The manufacturer issues an authorised distributor letter (Yetkili Distribütörlük Belgesi) naming that importer for the devices it covers.
If the manufacturer is established outside both Türkiye and the EU, it also needs an authorised representative, and the mandate is declared in ÜTS. Our guide to authorised representatives in Türkiye covers that part.
The documents, and what Türkiye asks for
TİTCK announcement 2022/KK-1 sets out, document by document, what an importer uploads for a foreign manufacturer's device. In outline:
| Document | What is uploaded |
|---|---|
| EU declaration of conformity | The original with an apostille or Turkish consular legalisation, and a sworn Turkish translation. |
| Notified body certificate (MDR/IVDR or legacy) | The complete certificate with all annexes, apostilled or legalised (or a notarised copy where it can be verified online), with a sworn translation if it is not in Turkish. The data entered in ÜTS must match the certificate exactly. |
| ISO 13485 certificate | Apostille or legalisation, and a sworn Turkish translation. |
| Authorised distributor letter | Apostille or legalisation, and a sworn Turkish translation. |
| System or procedure pack statement (Article 22) | Apostille or legalisation, and a sworn Turkish translation. |
| Instructions for use | The current original from the technical file and its Turkish translation. A multilingual IFU that already includes Turkish is uploaded in full. The revision date is recorded in ÜTS. |
| Label | The original label, together with the packaging where label information appears on it. |
The apostille or legalisation has to come from the manufacturer's country, or, for a manufacturer outside the EU, from the country of its EU authorised representative. The 2026 guide adds an upload option for each original (e-signed, e-apostilled or unsigned); unsigned originals are also sent to TİTCK on paper.
A sworn translation (yeminli tercüme) is made by a translator who has taken an oath before a Turkish notary and who signs and stamps the translation. Ask your importer whether a notarised copy is also wanted for a given file, because practice differs between documents.
Where registrations stall
- Data that does not match. TİTCK compares the ÜTS entry with the certificate. A manufacturer name, address or device name that was translated, abbreviated or re-spelled in one place and not another is enough for a query. Proper names stay exactly as they appear on the certificate.
- A Turkish IFU one revision behind. The Turkish file has to correspond to the current original in the technical file, and both are uploaded side by side.
- Stamps left out. The translation should cover the whole document, including stamps, signatures and the apostille.
- The wrong country on the apostille. It has to match the manufacturer's country, or the EU representative's country for non-EU manufacturers.
- Variants. Each size, model or configuration is a separate device record with its own barcode, so a Turkish IFU that covers several variants has to name them in the same way as the records.
A checklist for the importer and the manufacturer
- Agree who owns each ÜTS record: the firm, the device records, and the authorised representative's mandate.
- Collect the declaration of conformity, notified body certificate with annexes, ISO 13485 certificate and authorised distributor letter, with apostilles from the right country.
- Have the foreign documents translated by a sworn translator, stamps and apostille included, with names and addresses kept exactly as on the certificate.
- Translate the current IFU and check it against the revision held in the technical file.
- Check that the device names and variants in the IFU, on the label and in the ÜTS entry are the same.
- Put the Turkish files under change control, so a new certificate or IFU revision triggers an update in ÜTS.
Need ÜTS documents in Turkish?
We have two sworn English–Turkish translators on the team. We translate declarations of conformity, certificates, distributor letters and IFUs for ÜTS, a second translator revises every file, and standard delivery is 48 hours.
Request a quote See a translation sample (PDF)This guide is general information, not legal or regulatory advice. Requirements change and depend on your device, its classification and current TİTCK practice, so confirm your obligations with your regulatory adviser, importer or notified body.
Sources: TİTCK announcement 2022/KK-1; TİTCK ÜTS registration guide TCKKD-KLVZ-03, in force 13 May 2026 (summary); Tıbbi Cihaz Yönetmeliği, Official Gazette 31499, 2 June 2021; TİTCK; ÜTS. Related: Turkish labelling requirements for medical devices and IVDs.