A new Communiqué on the Import of Medical Diagnostic Kits No. 2020/19 was
published on the Official Gazette dated April 2, 2020 No. 31087. Accordingly,
for the custom procedures of temporary import regime of “the reagents used in laboratories
or diagnostics, standard reference materials defined as proprietary reagents
and dosed or packaged immune products
for retail sale” which are used for human medical diagnostics; a physical or
electronic letter of conformity issued by the Turkish Medicines and Medical
Devices Agency is sought by the customs administrations.
The provisions of this Communiqué do not apply to companies authorized by
the Ministry of Health and to the declarations registered before the date of
this Communiqué.
Additionally, applications to be made within the scope of the Communiqué
on the Import Control of Medical Devices No. 2020/16 published in the repeating
Official Gazette dated December 27, 2019 No. 30991 for the items described
above will be submitted after the letter of conformity is received from the
Agency.