TR 
EN 
As per the new announcement of Turkish Medicines and Medical Devices Agency (“the Agency”) regarding the Communiqué on the Import of Medical Diagnostic Kits No. 2020/19 (the Communiqué”) published on the Official Gazette dated April 2, 2020 No. 31087; a physical or electronic letter of conformity letter has to be issued by the Agency for the custom procedures of certain human medical diagnostic kits. Accordingly:
(i) A preliminary permit will be issued for the products placed on the market only within the scope of the In-vitro Medical Diagnostic Devices Regulation (“the Regulation”).
(ii) Laboratory products for general use (environment, food, chemistry etc.), raw materials used in kit production and borderline products are not covered by the relevant Communiqué and a preliminary permit will not be issued for these products.
(iii) Import preliminary permit applications will be made only through the Electronic Information Management System (“EBS”) as per the Agency’s announcement regarding the import applications of medical diagnostic kits dated April 3, 2020.
(iv) The products for which an application for import preliminary permit will be submitted must be registered in the Product Tracking System (“ÜTS”).
For all products that are in the scope of the Regulation and are currently registered in ÜTS as Covid-19 diagnostic kit as of the date of the announcement:
(i) The General Directorate of Public Health’s (“the General Directorate”) opinion will be taken in terms of comparative compliance tests, which demonstrate that the product meets the relevant Regulation requirements in terms of basic safety and performance parameters. Products that are approved by the General Directorate will continue to be registered at ÜTS.
(ii) For products that are not given a positive opinion by the General Directorate, companies that register these products with ÜTS will be given a revision period and will be asked to perform the relevant studies within this period.
For the product applications that are not registered in the ÜTS as of the publication date of the announcement; at the product registration stage, relevant companies will be asked to submit a letter of conformity by the General Directorate regarding comparative compliance tests in terms of basic safety and performance parameters of the products. In this regard, an import license will be issued for the products that will be the basis for the tests to be carried out by the General Directorate.
Along with the “Announcement Amending the Announcement No. 2019 / KK-9 on Medical Device and Document Registration Applications No. 2020 / KK-2” dated February 5, 2020, “Provisional Announcement No. 2020 / KK-5 Regarding Documents Required to be Apostilled or Embassy / Consulate Approved No 2020 / KK-2” dated March 26,2020 will be applicable for the document registration applications of Covid-19 diagnostic kits. For the products that are within the scope of the Communiqué and are not a Covid-19 diagnostic test, no additional studies will be required for ÜTS registration.
