Recent Developments
The Turkish Medicines and Medical Devices Agency (“TİTCK“) published the Guideline on the Registration of Technical Service Providers and Relevant Technical Personnel (“Guideline“) on March 7, 2019. The Guideline sets out the principles and procedures regarding the registration of technical service providers and relevant technical personnel to the Product Tracking System (ÜTS).
What’s New?
Pursuant to the TİTCK’s Circular No. 2019/1, technical service providers and relevant technical personnel of medical devices subject to the after-sales maintenance and repair process must register with the ÜTS. Accordingly, the Guideline provides companies with easy and convenient instructions regarding the registration procedures on the ÜTS. Companies can follow these instructions, which are elucidated with system screenshots and step-by-step explanations in the Guideline, to effectuate their registrations through the ÜTS.
By requiring technical service providers and technical personnel to register with the ÜTS, the TİTCK aims to track corrective actions regarding after-sales services for medical devices, such as maintenance and repair, in order to ensure patient and product safety.
The Guideline is available on the TİTCK’s website (in Turkish).
Conclusion
The TİTCK continues to provide guidance for medical device companies. Companies should follow the TİTCK’s announcements and make their required registrations through the ÜTS regarding technical service providers and technical personnel by following the instructions in the Guideline.
