Recent Development

The Turkish Medicines and Medical Devices Agency (“TİTCK”) recently announced that the registration pages of the Product Tracking System (“ÜTS”) for medical devices are now available.

Background

The TİTCK and the Scientific and Technological Research Council of Turkey ("TÜBİTAK") executed an agreement on January 7, 2014, establishing the ÜTS. The ÜTS registers, tracks, and inspects medical devices which are produced in or imported to Turkey. The TİTCK had previously announced that the Turkish National Data Bank for Medicines and Medical Devices’ data (“TİTUBB”) would be transferred to the ÜTS upon its launch.

What the Announcement Says

The TİTCK has announced that as of June 7, 2017, the TİTUBB will no longer accept new data entries and that the ÜTS is accepting registration applications starting on June 12, 2017. In this regard, as of June 12, 2017;

  • The data relating to the medical devices which are already registered with the TİTUBB will be temporarily transferred to the ÜTS to be reevaluated by their producers or importers;
  • Producers and importers will be able to apply for company registration as well as product registration for their temporarily saved products and any other new products on the ÜTS;
  • Producers and importers will be able to activate their accounts through their TİTUBB registration numbers; and
  • Producers and importers can only submit applications for free trade certificates to the ÜTS.

The TİTCK also published ÜTS guidelines on its website.

Conclusion

Medical device companies should take note of the new dates and procedures with regard to the use of the ÜTS and closely follow the TİTCK’s website for any further guidelines.