The Communiqué on the Import of Medical Diagnostic Kits (“Communiqué“) was published in the Official Gazette No. 31087 on April 2, 2020. According to the Communiqué, the import of reagents, standard (reference) substances and certain immunity products (collectively, “medical test kits“), which may also be used for COVID-19 tests, are now subject to the Turkish Pharmaceuticals and Medical Devices Authority’s (“TİTCK“) approval. The TİTCK announced the procedures for import approval applications in the scope of the Communiqué.
The TİTCK will issue approval letters for products placed on the market in the scope of the Regulation on In-Vitro Diagnostic Medical Devices (“Regulation“). Products to be imported further to the TİTCK’s approval must be registered with the Product Tracking System (tr. ÜTS).
With respect to products registered as “COVID-19 test kits” in the ÜTS, the General Directorate of Public Health must initially give its positive opinion that the products meet the conditions under the Regulation. As for the COVID-19 kits that are not registered with the ÜTS, the General Directorate of Public will issue a conformity letter for the completion of the ÜTS registration and import approval application. Detailed information on the import approval applications and ÜTS registrations of COVID-19 medical diagnostic kits is available online here (in Turkish)
Import approval applications will be made through the Electronic Application System (tr. EBS) under the Medical Diagnostic Kit Import Application section. Applicants must add the relevant product to the system by entering the product number and indicate the country of import. As customs declarations are issued separately for each country, import approval applications should also be made separately for each country. Applicants must then fill out and e-sign the application petition on the TİTCK’s website and upload the petition to the system.
If the application is approved by the TİTCK, the system will automatically assign a Single Window System (tr. TPS) number and the number will be sent to the applicant’s email address registered in the system. The TPS number will be valid for six months. Detailed information on import approval application through the EBS is available online here (in Turkish).
The TİTCK continues to take active steps to protect the public against the COVID-19 pandemic in Turkey. Any real or legal persons wishing to import COVID-19 test kits must apply to the TİTCK for import approval. Accordingly, all relevant persons and companies must comply with the TİTCK’s instructions for import approval applications and follow the TİTCK’s announcements in this regard.
Please refer to https://www.esin.av.tr/coronavirus-desk/ for our client alerts regarding the legal consequences of COVID-19 on other areas.