Authorised representative for medical devices in Türkiye

By Mesut Can Güroy, sworn English–Turkish translator · Updated 31 October 2026

A manufacturer established outside Türkiye and the EU cannot place a medical device or IVD on the Turkish market on its own. It needs an authorised representative, appointed in writing and recorded in ÜTS. This guide explains when that applies, what the mandate has to say, what the representative does, and how the role differs from the importer and the distributor.

When you need one

Under Article 11(1), a manufacturer that is not established in Türkiye or in an EU Member State may place a device on the Turkish market only after designating a sole authorised representative. Because Türkiye's device regulations follow the EU texts under the Customs Union, an EU-established representative is accepted. Law No. 7223 on product safety defines an authorised representative as one established in Türkiye, so if you are relying on an EU representative, confirm the current TİTCK practice for your device class with your importer or adviser.

TİTCK announcement 2023/KK-6 of 29 November 2023 deals with exactly this case: a manufacturer outside Türkiye and the EU, and the EU authorised representative it has appointed. The agreement or mandate between them is declared to TİTCK through ÜTS.

What the mandate has to say

• It is a written document, and it takes effect when the representative accepts it in writing.
• It covers at least all devices in the same generic device group. One group cannot have two representatives.
• It sets out the tasks the representative carries out for the manufacturer. The representative gives TİTCK a copy on request.

What the representative does

Article 11(3) lists the tasks the mandate must allow the representative to carry out. They include:

• checking that the declaration of conformity and the technical documentation have been drawn up, and that the conformity assessment has been carried out;
• keeping copies of the technical documentation, the declaration of conformity and the certificates available to TİTCK;
• complying with the registration obligations, including ÜTS, and checking the manufacturer's UDI and registration obligations;
• providing TİTCK, on request, with the information and documents that show conformity, in Turkish and/or an official EU language;
• passing on requests for samples or access to the device, and cooperating on corrective and preventive action;
• forwarding complaints and suspected incident reports to the manufacturer at once;
• terminating the mandate if the manufacturer acts against its obligations, and informing TİTCK and the notified body of the termination and the reasons.

The core manufacturer obligations stay with the manufacturer and cannot be handed to the representative: conformity assessment, technical documentation, the quality management system and post-market surveillance among them.

Liability

Under Article 11(5), if the manufacturer has not complied with its general obligations, the authorised representative is legally liable for defective devices on the same basis as the manufacturer, jointly and severally with it. That is why representatives look closely at the technical file before they accept a mandate, and why the contract usually deals with indemnities and product liability insurance.

In the EU MDR the representative must also have a person responsible for regulatory compliance permanently and continuously at its disposal (Article 15(6)). The Turkish regulation follows the same model, so expect the same question from TİTCK.

Changing representative

A change of representative is agreed between the manufacturer, the outgoing representative where possible, and the incoming one. The agreement covers the end and start dates, how long the outgoing representative may still appear on labels, the handover of documents, and who passes on complaints received afterwards. The ÜTS records have to be updated at the same time, or a recall can reach the wrong company.

Representative, importer, distributor: who does what

One company can hold more than one role, but each role needs its own basis. An importer becomes your authorised representative only through a written mandate that it accepts.

Translation is where the roles often blur. Supplying the Turkish information required by Annex I is not in itself a modification of the device. But an importer or distributor that translates the labelling or IFU has to say so on the device or its packaging, run a quality management system with procedures that keep the translation accurate and up to date, and notify the manufacturer and TİTCK at least 28 days before supplying the relabelled device, with a notified body certificate for that system. Most manufacturers avoid this by supplying the Turkish text themselves, under their own change control.

The documents that need Turkish

• The authorised distributor letter and the declaration of conformity are uploaded to ÜTS with a sworn Turkish translation. Our guide to ÜTS documents lists the rest.
• The labelling and IFU have to be in Turkish before the device is placed on the market. See our guide to Turkish labelling requirements.
• Technical documentation and other evidence of conformity are provided to TİTCK on request, in Turkish and/or an official EU language.

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: Tıbbi Cihaz Yönetmeliği, Official Gazette 31499, 2 June 2021; TİTCK announcement 2023/KK-6, 29 November 2023; TİTCK announcement 2022/KK-1; TİTCK.