Omega Depot Regulatory Intelligence

Türkiye Import & Regulatory Knowledge Hub

Operational guidance grounded in official sources, with review dates, product scope and direct regulatory citations.

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Operations & Compliance

Importer of Record and Responsibility Matrix

Who the importer of record is, which responsibilities cannot be delegated and how the matrix is built. The responsibility map of the import chain.

Kayıt sahibi ithalatçılar ve distribütörlerÜretici temsilcilikleriTüm düzenlemeye tabi ürün ithalatı
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Laboratory Equipment & Consumables

Centrifuge and Laboratory Equipment Import

Which GTİP lines cover centrifuges and analysers, how CE and communiqué controls work for laboratory equipment, and why the equipment-versus-consumable split matters.

Santrifüjler ve ayırma ekipmanlarıAnaliz ve ölçüm cihazlarıGenel amaçlı laboratuvar ekipmanları
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Phones, Tablets & Connected Devices

Commercial Import of Mobile Phones

Which document chain does commercial phone import require? Surveillance, CE control, IMEI registration and Turkish-language requirements in one file.

Ticari amaçla ithal edilen cep telefonlarıHücresel bağlantılı akıllı cihazlarİletişim amaçlı tüketici elektroniği
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IVD & Laboratory Kits

IVD, RUO or Chemical: Classifying Laboratory Kits

Is the kit an IVD, RUO or a chemical? Which regulatory regime the intended-use claim triggers, how the GTİP is chosen and how the import file is built.

Laboratuvar kitleri ve reaktiflerRUO etiketli araştırma ürünleriGenel kimyasal preparatlar ve tanı amaçlı kullanılan materyaller
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Medical Devices

Medical Device Import Controls under Communiqué 2026/16

How communiqué 2026/16 inspects medical device imports, which documents TAREKS requests and how ÜTS registration ties into customs. The annual control frame.

Tıbbi cihaz ve tıbbi cihaz bileşenleriIVD (in vitro tanı) cihazları ve aksesuarlarıCE işaretli düzenlemeye tabi sağlık teknolojisi ürünleri
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Medicines & IMP

IMP Import into Türkiye for Clinical Trials

Which permit chain governs investigational medicinal product import, which document customs asks for, and what depot and labelling require. The end-to-end guide to IMP supply.

Klinik araştırmalarda kullanılan araştırma ilaçları (IMP)Plasebo ve klinik tedarik kapsamındaki ilaç formlarıAraştırma amacıyla getirilen etkin madde ve formülasyon örnekleri
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TAREKS & Product Safety

TAREKS Applications: Evidence, Risk and Timing

How to prepare a TAREKS conformity declaration, which documents to upload and which routes the risk analysis opens. Evidence, risk and timing before the customs declaration.

Ürün güvenliği ve denetimi tebliğleri kapsamındaki ürünlerKlinik araştırma ve laboratuvar amaçlı düzenlemeye tabi ürünlerCE işaretli elektrikli ekipman, makine ve oyuncaklar
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