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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Phones, Tablets & Connected Devices

IMEI, MCKS and Device Registration

How IMEI registration is done, how commercial and personal processes diverge, and what happens to unregistered devices. The practical guide to the device registration regime.

IMEI kaydı gerektiren telefonlar ve hücresel tabletlerMerkezi cihaz kayıt sistemine tabi cihazlarKayıt durumları ve şebeke erişimi yönetilen cihazlar
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Phones, Tablets & Connected Devices

Cellular vs Wi-Fi-only Tablet Import

Is importing a cellular tablet the same as a Wi-Fi one? Where IMEI registration is mandatory and whether radio conformity applies to both. The operational counterpart of the difference.

Hücresel bağlantılı tabletlerYalnız Wi-Fi çalışan tabletlerBağlantılı tüketici cihazları ve okuyucular
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IVD & Laboratory Kits

Biological Samples and Temperature-controlled Kit Logistics

How biological samples are packaged, how temperature-controlled kits are shipped and how reverse logistics is recorded. The moving half of the diagnostic chain.

Biyolojik numune taşıma ve paketleme hizmetleriSıcaklık kontrollü kit sevkiyatlarıNumune geri lojistiği ve saha toplama materyalleri
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IVD & Laboratory Kits

Multi-component Kit Classification and Documentation

Is the kit as a whole or its components classified, how are multi-vendor components documented and how is the set declaration built? The file rules of multi-component kits.

Çok bileşenli tanı kitleri ve setleriFarklı üreticilerden bileşen içeren setlerKitlerle birlikte teslim edilen yazılım ve sarflar
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IVD & Laboratory Kits

Reagents, Calibrators and Control Materials

What the statuses of reagents, calibrators and control materials determine, how traceability is proven and how the import file is built. The three legs of the diagnostic chain.

Tanı amaçlı reaktifler ve preparatlarKalibratörler ve metrolojik izlenebilirlik materyalleriKontrol materyalleri ve iç kalite kontrol ürünleri
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IVD & Laboratory Kits

IVDR Scope and Risk Classes

Where IVDR scope begins, how risk classes A to D are determined and how the class shapes conformity assessment. The class map of diagnostic products.

In vitro tanı cihazları ve kitleriPerformans değerlendirme ürünleriTanı amacıyla kullanılan yazılım ve aletler
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Medical Devices

Importing Devices for Clinical Investigations

Which permit governs investigational device import, when a device without CE may enter, and how labelling and records run. The rules of clinical investigation device supply.

Klinik araştırma amaçlı getirilen tıbbi cihazlarCE dışı veya araştırma sürümü cihazlarPerformans değerlendirmesi için gelen IVD ürünleri
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Medical Devices

Sterile, Measuring and Single-use Devices

Why sterile, measuring and single-use devices get special treatment. The notified body, sterilisation evidence and the limits of reuse.

Steril teslim edilen tıbbi cihazlar ve setlerÖlçüm fonksiyonlu cihazlarTek kullanımlık ürünler ve yeniden kullanım riskleri
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Medical Devices

Medical Device Classification under the MDR Framework

Device or not, class I or class III? How to read the MDR classification rules, what the class changes and how a classification error hits the import.

Tıbbi cihaz tanımına giren tüm ürünlerSınırda kalan wellness ve genel amaçlı ürünlerCihaz aksesuarları ve yazılım bileşenleri
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