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ÜTS DOCUMENT REGISTRATION

Get the necessary UTS documents for your medical device products with expert support.

UTS PRODUCT REGISTRATION

Register your medical devices, imported or manufactured products in ÜTS in accordance with the legislation.

ÜTS COMPANY REGISTRATION

Complete your company registration with the Turkish Medicines and Medical Devices Agency quickly and accurately.

UTS consultancy

We are with you in the ÜTS registration and certification processes,

Medical Device Product Registration Consultancy

Medical Device UTS Production/Import Notifications

Medical Device Sales Center Authorization Certificate

ÜTS Document - Sworn Translation

Medical Device Document Registration Consultancy

Medical Device UTS Import/Issuance Notifications

Medical Device UTS Product Movements

Cosmetics UTS Registration Consultancy

ÜTS Company Registration Consultancy

Preparing an MDR Declaration of Conformity

Medical Device UTS Inventory Notifications

Preparation of CE Declaration of Conformity

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Frequently Asked Questions (FAQ)

1. How to register a company on ÜTS?

For ÜTS company registration, you can log in via the Electronic Application System (EBS) with your e-Government password, e-signature or mobile signature. Then, a new company record is created from the "My Company Applications" screen. After the application is completed with the necessary documents, it is approved by TİTCK and transactions can be carried out via the ÜTS portal.

2. What is a medical device document registration?

Medical device document registration is the process of defining the device in the ÜTS system according to the CE certificate, technical file and product class. This registration ensures that the device is registered in the ÜTS with the necessary documents before it is placed on the market.

3. What documents are required for medical device product registration?

Tıbbi cihaz ürün kaydı için gerekli belgeler şunlardır:

  • CE Belgesi

  • Uygunluk Beyanı

  • Kullanım Kılavuzu

  • Teknik Dosya Özeti

  • GTIN barkod bilgileri

  • Üretici veya ithalatçıya ait evraklar​

Bu belgeler, ÜTS üzerinden yapılan başvuru sırasında sisteme yüklenmelidir.

4. How should the MDR declaration of conformity be prepared?

The MDR (EU 2017/745) declaration of conformity must be prepared based on the technical file according to the risk class of the product. This declaration is usually issued by the manufacturer and states that the device complies with the relevant regulations.

5. What is the ÜTS import/export notification?

The receiving/giving notification in ÜTS is made for the purpose of tracking stock movements (sales, returns, transfers). The notification is made via e-signature through the system, depending on which company the product is given to. The other party must also make a receiving notification in the same way.

6. How to submit production/import notification to ÜTS?

Üretici veya ithalatçı firma, ürünün GTIN ve parti/lot bilgileriyle birlikte ÜTS portalı üzerinden üretim veya ithalat bildiriminde bulunmalıdır. Bu işlem, ürünün piyasaya arz edilmeden önce yapılması gereken zorunlu bir adımdır. ​

7. When should inventory notification be made?

Inventory notification must be made via ÜTS based on GTIN of the products in stock at the end of the year or in the periods determined by TİTCK. This notification is important for stock tracking and control.

8. How are product movements controlled in ÜTS?

The entire movement history of the product (receiving, giving, selling, etc.) can be tracked using the GTIN number via the ÜTS portal. This allows the product to be tracked throughout the supply chain.

9. What is a sales center authorization certificate?

This is a document that companies that will sell medical devices must obtain from the Provincial Health Directorate. Medical devices cannot be sold without this document. The documents and process required for the document application are determined by the relevant directorate.

10. What information should the CE declaration of conformity contain?

The CE declaration of conformity must include the product name, manufacturer information, declaration of conformity date, relevant regulation reference and manufacturer signature. In addition, the declaration must be based on the technical file.

11. Does my product have to be registered in the ÜTS system?

The registration requirement is determined by examining the product's definition, intended use and regulatory counterparts. Even if the risk class is low, ÜTS registration is mandatory for most medical devices.

12. What is a GTIN and why is it needed?

GTIN (Global Trade Item Number) allows products to be uniquely identified worldwide. The GTIN number is mandatory for product registration in ÜTS and increases the traceability of the product.

13. Is it possible to register for ÜTS without a CE certificate?

No, ÜTS registration cannot be made without a CE certificate for medical devices. The CE certificate is a document that shows that the product complies with the relevant regulations and forms the basis of the registration process.

14. Is ÜTS registration mandatory for cosmetic products?

No, ÜTS registration is not mandatory for cosmetic products. However, product notification must be made through the Cosmetic Product Notification System (KÜBİS) run by the Turkish Medicines and Medical Devices Agency (TİTCK). This notification must be made before the product is placed on the market.

15. Which documents require a sworn translation?

Documents prepared in a foreign language must be translated into Turkish under a sworn document. These documents include CE certificates, technical files, authorization documents and other official documents. Sworn translations must be notarized.

16. How should production documents be prepared within the scope of MDR?

Under the MDR (EU 2017/745), the documents that manufacturers must prepare are:

  • Risk Analysis

  • Clinical Evaluation Report

  • Post-Market Surveillance Plan

  • Declaration of Conformity

These documents must be prepared and included in the CE certification process in order to prove the safety and performance of the product.

17. Are foreign documents valid in Turkey?

Documents issued abroad must be translated into Turkish with a sworn translation and apostilled if necessary in order to be valid in Türkiye. In this way, they become acceptable by TİTCK.

18. How does an importer company register to ÜTS?

Importer companies must create a company record via the ÜTS portal. After the application is made with the necessary documents, they are approved by TİTCK and become active in the system. During this process, the authorized person of the company must have an e-signature.

19. How should product labeling be in accordance with ÜTS?

Ürün etiketlerinde aşağıdaki bilgilerin bulunması gerekmektedir:

  • Ürün Adı

  • Üretici Bilgileri

  • GTIN (Global Ticari Ürün Numarası)

  • CE İşareti

  • UDI (Unique Device Identification)

  • Kullanım Amacı​

Bu bilgiler, ürünün izlenebilirliğini ve güvenliğini sağlamak amacıyla etiket üzerinde açıkça belirtilmelidir.

20. Where to get GTIN number?

GTIN number is obtained from GS1 Turkey in Türkiye. A separate GTIN definition must be made for each product variant. GTIN number can be obtained by applying through GS1 Türkiye's official website.

21. Can the records entered into ÜTS be updated?

Yes, some records entered into the ÜTS system can be updated. Changes can be made in areas such as product information and stock quantities. However, some changes may require a re-application. Therefore, the relevant TİTCK guides should be reviewed before the update process.

ÜTS Registration & Consultancy Services Price Offer Form

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