To export medical devices to Türkiye, register the product and company in TİTCK's UTS system, appoint a Turkish authorized representative, and prepare technical, quality system and country-of-origin approval documents. CE documentation can serve as the main technical basis.
Direct Answer
To export medical devices to Türkiye, the product and company must be registered in the UTS system operated by the Turkish Medicines and Medical Devices Agency (TİTCK). Depending on the risk classification, the manufacturer must submit a technical file, quality system evidence, and proof of approval in the country of origin. A Turkish authorized representative is responsible for registration and post-market obligations. Türkiye's regulatory framework is closely aligned with the EU MDR, so CE documentation can generally serve as the main technical basis.
Key Requirements
- Competent authority: Turkish Medicines and Medical Devices Agency (TİTCK) — https://www.titck.gov.tr/
- System: UTS (Ürün Takip Sistemi), the Product Tracking System
- Local requirement: An authorized representative established in Türkiye
- Core documents: (1) technical file; (2) CE/quality system evidence; (3) proof of approval in the country of origin; (4) Turkish-language labels and instructions for use
- Regulatory alignment: Closely aligned with the EU MDR
Professional Notes
Official TİTCK website: https://www.titck.gov.tr/
Verification date: 2026-11-02.
Frequently Asked Questions
Do I still need to register in Türkiye if I have a CE certificate?
Yes. A CE certificate provides the technical basis, but Türkiye still requires registration in the UTS system and an authorized representative to assume the relevant obligations.
Must labels be in Turkish?
Yes. Turkish-language labeling is required, and the specific format should follow TİTCK requirements.
Source and Disclaimer
Sources: the official website and regulatory pages of the authority listed above; verification date: 2026-11-02.
This article summarizes regulatory information and does not constitute legal advice. The latest requirements of the competent authority prevail.
Ameli is an overseas registration work platform for medical device companies. It is not a CRO and not an authorized representative.
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