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

Labelling and Turkish-language Information

Which information must be in Turkish, what the label warns about and what a non-compliant label does at customs. The guide to Turkish-language information duties.

Düzenlemeye tabi ürünler ve ambalajlarıTürkçe etiket ve kullanım bilgisi yükümlülüğü olan ürünlerEtiket tasarım ve onay süreçleri
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Operations & Compliance

CE, Declaration of Conformity and Technical File Check

What a declaration of conformity must contain, what the technical file carries, and how declaration-product matching is verified. The CE document set control guide.

CE işaretli ürünlerUygunluk beyanı düzenlenen ürünlerTeknik dosya tutma yükümlülüğü olan üretici ve ithalatçılar
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Operations & Compliance

Pre-shipment Document Preparation Timeline

Why the document calendar is built backward from the shipment date, which document is ready at which stage, and where the critical path runs. The pre-dispatch planning guide.

Tüm ticari ithalat sevkiyatlarıKontrol kapsamındaki düzenlemeye tabi ürünlerSevk öncesi belge hazırlık süreçleri
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Laboratory Equipment & Consumables

PPE, Medical Device or General-use Product?

Is a surgical mask a medical device, an FFP respirator PPE, and can it be both? How intended use sets status and which documents come from which regime.

Kişisel koruyucu donanım ve korunma ürünleriTıbbi cihaz sınırındaki koruyucu ürünlerGenel kullanıma yönelik koruyucu eşya
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Laboratory Equipment & Consumables

Laboratory Plasticware Import and Classification

Under which position are petri dishes, pipette tips and centrifuge tubes declared, when sterile plasticware gains medical status, and what volumetric marks require.

Plastik laboratuvar kapları ve sarflarıPipetler, pipet uçları ve ölçüm kaplarıSteril ve steril olmayan plastik sarf ürünleri
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Laboratory Equipment & Consumables

Gloves, Tubes, Swabs and Syringes: Product Scope

Are gloves, tubes, swabs and syringes medical devices or consumables? Scope decisions, GTİP splits, ÜTS registration and the sterile document set.

Tıbbi eldivenler ve muayene eldivenleriVakumlu tüpler ve numune kaplarıSwab ve numune alma setleri
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Laboratory Equipment & Consumables

Medical Freezers and Cooling System Imports

Which GTİP covers medical freezers, what the refrigerant gas and energy labelling rules demand, and how validation and installation are planned. The cooling import guide.

Laboratuvar ve medikal tip dondurucularSoğuk saklama dolapları ve derin dondurucularSoğutucu sistemler, üniteler ve aksamları
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Phones, Tablets & Connected Devices

Separate Controls for Adapters, Batteries and Accessories

Why adapters and batteries are inspected separately from the main product, what the battery communiqué requires and how in-box accessories are declared. The guide to accessory controls.

Şarj adaptörleri ve güç kaynaklarıPiller ve akümülatörlerAna ürünle birlikte veya ayrı ithal edilen aksesuarlar
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Phones, Tablets & Connected Devices

Radio Equipment Conformity and the CE Technical File

What radio equipment conformity requires, what enters the technical file and how frequency compatibility is verified. The radio layer of the CE file.

Telsiz ekipmanı sayılan tüm ürünlerWi-Fi ve Bluetooth özellikli cihazlarCE teknik dosyası hazırlanan bağlantılı ürünler
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