Medical devices intended to be sold in Turkey must be registered either through a local office or an authorized representative incorporated in the country Foreign manufacturers without a presence in Turkey need a local representative to fulfill this requirement. Ardis, as an in-country representative, holds the registration on behalf of foreign companies and manages all necessary procedures with Turkish authorities.

 

Key requirements include:

 

1) 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 Drugs and Medical Devices National Database).

2) A local representative, known as the "Registration Holder," must submit UTS registrations.

3) The local representative must be a registered entity in Turkey and must have a company registration in the EBS  (Electronic Application System).