Turkey medical device registration timeline
Source-linked clocksTurkish Medicines and Medical Devices Agency (TİTCK) review clocks and end-to-end planning ranges, using the EU-aligned (I, Is, Im, Ir, IIa, IIb, III) classification system.
1 pathways1 of 1 clocks verifiedvalidity Indefinite (registration does not expire)MDSAP not acceptedreviewed 2026-08-29mevzuat.gov.tr
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I (non-sterile, non-measuring, non-reusable)(Self-declaration, then ÜTS registration) Art. 52(6) of the Tıbbi Cihaz Yönetmeliği: a Class I manufacturer draws up the declaration of conformity itself once the Annex II and III technical documentation is prepared, so no body and no TİTCK review stand between the file and the market | 0 days | 6-9 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesTurkey Medical Device Registration Process
Step-by-step TİTCK registration process. Total estimated timeline: 6-9 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by TİTCK. Appoint a Turkish Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to TİTCK including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksTİTCK reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. TİTCK may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, TİTCK issues Turkey market authorization certificate.
Summary: The Turkey medical device registration process through Turkish Medicines and Medical Devices Agency (TİTCK) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Prior approval recognition
CE Mark (EU MDR)The Tıbbi Cihaz Yönetmeliği transposes EU MDR essentially verbatim, so a CE certificate from an EU notified body is directly usable for the ÜTS filing and there is no separate Turkish product approval to shorten. One divergence matters going forward: from 25 February 2027 the EU notified body issuing that certificate is capped at 170 days by Regulation (EU) 2026/977, while a Turkish-designated body issuing the same certificate stays uncapped because Turkey has not transposed it.None published
FDA 510(k)/PMAUsable as supporting technical evidence only. Market entry runs on a CE or Turkish notified-body certificate, and a US clearance substitutes for neither.None published
Key requirements
- Local Authorized Representative (TR Representative) required for foreign manufacturers
- CE marking accepted for imports; Turkish labeling and UDI requirements apply
- Clinical investigation (Art. 70): TİTCK decides within 10 days whether the study falls under the regulation and whether the file is complete, within 5 days of receiving clarifications, and notifies the authorisation within 45 days of the validity date, extendable by 20 days to consult experts
- Substantial amendments (Art. 75) may be implemented no earlier than 38 days after notification, extendable by 7 days for expert consultation; post-market clinical follow-up studies that add invasive or burdensome procedures need 30 days prior notice (Art. 74)
- Coordinated multi-country assessment (Art. 78): 6 days to settle the coordinating country, 10 days for completeness, a draft report at 26 days, comments to 38 days and the final report at 45 days, extendable by 50 days for Class IIb and III expert consultation, with the single decision notified 5 days later
- Sales-centre certificate for importers/manufacturers: 15 business days, extension 45 business days
Primary regulator sources
Reviewed 2026-08-29. End-to-end totals remain planning estimates.
Keep researching this market
More Turkey medical device resources
Continue with this market
Source-linked review clocks verified against TİTCK publications · full review 2026-08-29 · row IDs are stable — cite as registration-timeline:turkey:class-i