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Legal Alerts

December 19, 2016

TİTCK Advises Medical Device Companies on the New Product Tracking System

Legal Alerts
Healthcare

Recent development

The Turkish Medicines and Medical Devices Agency (“TİTCK”) recently announced on its website the requirements for medical device companies regarding the Product Tracking System (“ÜTS”), which will soon be adopted for use.

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 ÜTS will soon be launched, and the Turkish National Data Bank for Medicines and Medical Devices’ data (“TİTUBB”) will be transferred to the ÜTS.

What the announcement says

The TİTCK announced requirements for medical device companies during the process of data transfer from the TİTUBB to the ÜTS.
Prior to the data transfer, licenses obtained by the companies in accordance with the Regulation on the Sales, Advertisement and Promotion of Medical Devices (the “Regulation”) and their Central Registry Record System (“MERSIS”) numbers will be verified. In the event of any missing or incorrect information, the data transfer will not be carried out for the relevant company.
The TİTCK, therefore, requires companies to take the following actions to prevent interruptions in the transfer process:

  • To ensure the information provided in the MERSIS is accurate, such as, tax numbers, information on the company official (their Turkish National Identity Number) and contact details of the company, either from the website http://mersis.gumrukticaret.gov.tr or Provincial Commercial Registries.
  • To have available the relevant information on the companies’ licenses within the scope of the Regulation and Core Resource Management System (“ÇKYS”) numbers.

The TİTCK continues to provide companies with detailed information and guidelines regarding ÜTS procedures on its website.

Actions to consider

Medical device companies should take note of these new requirements and take the necessary steps to prevent any problems that may arise regarding the data transfer to the ÜTS.