TITCK Simplifies Medical Device and IVD Registration in Türkiye

The Turkish Medicines and Medical Devices Agency (TİTCK) has introduced a significant simplification to the registration process for medical devices and IVD products in Türkiye.

Under the updated guidance, manufacturers can now submit electronic versions of key registration documents, including electronically signed CE Certificates issued by Notified Bodies and electronically signed Declarations of Conformity (DoC). As a result, apostilled documents, hard-copy originals, and international courier shipments are no longer required for registration purposes.

This regulatory update is expected to streamline registration procedures, reduce administrative burden and costs, and accelerate market access for manufacturers seeking to place medical devices and IVD products on the Turkish market.

The change represents another important step toward the digitalization and modernization of regulatory processes in Türkiye.

🔗For further details, please refer to the official TİTCK guidance