On April 14, 2020, the Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK“) published the Approval Application Guidelines for the Import and Export of Certain Medical Devices Due to the COVID-19 Outbreak. The TİTCK prepared the guidelines by gathering all of its announcements issued during the COVID-19 outbreak in relation to approval procedures. The Guidelines are available online here (in Turkish).
As part of the measures to fight COVID-19, the import and export of certain products are subject to the TİTCK’s approval to ensure the accessibility to safe products; the procurement management of critical products necessary for COVID-19 treatments; the smooth functioning of health services; and the protection of public health.
In this regard, companies must obtain the TİTCK’s approval for the export of personal protection equipment such as protective masks; liquid-proof aprons and goggles; and products placed on the market pursuant to the Regulation on Medical Devices such as medical and surgical masks, sterile medical gloves, intubation tubes and intensive care monitors; and the import of certain medical diagnosis kits.
Approval applications will be made through the Electronic Application System (tr. EBS). Products that fall under the medical devices regulations must be registered with the Product Tracking System (tr. ÜTS) for approvals.
As customs declarations are issued separately for each country, 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 TİTCK approves the application, 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 for import approvals will be valid for six months, whereas the TPS number for export approvals will be valid for 15 days.
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 or export the relevant personal protection equipment and medical materials must apply to the TİTCK for import/export 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 The Esin Attorney Partnership Coronavirus Helpdesk for our client alerts regarding the legal consequences of COVID-19 on other areas.