Who files the ÜTS registration, and who does not
Medical devices placed on the Turkish market must be registered in ÜTS, the national device database operated by the Turkish Medicines and Medical Devices Agency (TİTCK). The registration is filed by the economic operator established in Türkiye, the importer or the distributor, from its own ÜTS account. It is not filed by a foreign manufacturer, and it is not filed by an authorised representative on a manufacturer's behalf.
Who this is for
Companies established in Türkiye that hold a medical device sales centre authorisation certificate (tıbbi cihaz satış merkezi yetki belgesi) and are responsible for their own ÜTS records. We advise on company registration, document registration, product registration and TİTCK notifications.
Who this is not for
Manufacturers established outside Türkiye looking for a party to place their devices on the Turkish market. We do not act as importer or distributor, and we do not take that role.
Separate from the mandate
This is a separate engagement, under a separate contract, priced separately. It is not included in the annual authorised representative fee. The Article 11 mandate is an appointment that is valid on both sides of the EU-Türkiye Customs Union. That is a question of where the representative may be established, not a market-entry service.
Where it runs
ÜTS registration consultancy is handled through our Turkish-language site, medexmedikal.com.
FAQs
Is ÜTS registration included in the annual authorised representative fee?
No. Article 11 representation and ÜTS registration consultancy are separate services under separate contracts, and the annual fee covers Article 11 representation only. The ÜTS record itself is filed by the Türkiye-established economic operator that places the device on the market, your importer or distributor, from its own account.
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