Competent authority
authority.competent-authority
TİTCK / ÜTS
TITCK · structured requirements
🇹🇷 Turkey medical device regulatory data
Explore the medical device requirements currently available for Turkey, organized by topic and linked to official sources.
3 facts3 dimensions2 official sourceslatest verification 2026-08-13
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
Market-access route or official registration surface
registration.market-access-route
CE-marked devices and economic operators register in ÜTS under the EU-aligned framework; separate local sales/service obligations can apply.
Reliance & recognition
Which foreign decisions or evidence can be reused, with what effect and conditions?
EU CE under MDR/IVDR — customs union free circulation
reliance.reliance-edge-eu-ce-to-turkiye-approval-eu-ce-mdr-ivdr-turkiye
- Target
geo:tur
- SourceApproval
EU CE under MDR/IVDR
- EdgeType
Customs Union Free Circulation
- MarketAccessStrength
Direct With Local Obligations
- RegulatoryLayer
Product Marketing
- LocalApplicationRequired
No
- TargetDecisionRetained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- Turkish UTS, language, economic-operator, and surveillance obligations remain
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