The EU-aligned framework
The Turkish Medical Device Regulation mirrors the EU framework — with the Declaration of Conformity and PRRC-equivalent requirements.
Free field guide · PDF
Türkiye TITCK Medical Device Registration2026 Field Guide
The EU-aligned framework, ÜTS registration, and the authorized representative rule — with the SGK reimbursement reality.
- ÜTS registration
- 1 mo
- Regulation
- EU-aligned
- Official fee
- No fee
Sourced from the Turkish regulation and TİTCK registration practice.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — the Turkish regulation and TİTCK registration practice.
ÜTS registration timeline
Document application in ~1 week, ÜTS registration in ~1 month — currently with no official fee required.
The SGK reality
SUT codes, Tekil Takip unit tracking, and how the SGK reimbursement price sets your ceiling.
Sources & scope
- Medium, execution log: medical device registration in Turkey via ÜTS.
- Lexology, new Turkish medical device regulation aligned with EU regulations.
- mddionline.com, accessing Turkey's medical device market.
- bicakhukuk.com, medical device rules and regulations in Turkey.
This guide is market-access intelligence, not regulatory or legal advice. TİTCK pathways, ÜTS procedures, and reimbursement rules are product-specific — professional review is required before business use.
Market Access Strategy Session
Türkiye on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your TİTCK route — authorized representative selection, ÜTS registration, and the SGK reimbursement plan.
Professional review is required before business use.
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