IN COUNTRY RepresentatIon

Ardis Global

In-country representation as registration holder for medical devices.

Medical devices intended to be sold in Turkey must be registered by the manufacturer’s own office in Turkey or through a distributor incorporated in the country. As a result, for a foreign company to market its medical device in Turkey, they should either open their own subsidiary in Turkey or find an authorized representative in the Turkish market.

All medical devices must be registered with the MoH in the UTS (Product Tracking System ) and registrations and notifications must be made to TITUBB (Turkiye Drugsand Medical Devices National Database).

 Registration in the UTS must be submitted by a local representative in Turkey, who is called the “Registration Holder.”

The local representative must be a registered entity in Turkey and must have a
company registration in the EBS (Electronic Application System). Thus, foreign
manufacturers without an establishment in Turkey must appoint an in-country
representative to list their devices in the UTS.

Ardis, as a local representative, serves its customers as a registry holder who is authorized to register medical devices and carry out all relevant procedures in Turkey.

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