D01
Authority & regime
- Competent authority
- TİTCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu), the Ministry of Health agency defined as 'Kurum' in the regulation, executes the Turkish Medical Device Regulation.
1 source-linked fact
Checked 2026-08-25
TITCK · EuropeTurkey medical device regulatory resources
Every Turkey dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.
6 free resources23/25 topics with records5 regulations trackedAug 2026 fees reviewed
Everything we track for Turkey
Medical device regulations
Browse official TITCK regulations and guidance documents.
AI medical device classifier
Describe your device and get a preliminary TITCK risk class with an explanation and source links.
Additional certification and licence checker
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Turkey requirements.
Medical device regulation news
Follow recent TÄ°TCK / ÃœTS policy, guidance, safety, and compliance updates.
Government registration fees
Review current TÄ°TCK and ÃœTS medical-device tariff evidence.
Registration timeline
Which Turkish steps carry a deadline, and why the notified body assessment does not.
Changes after registration
Explore questions and sources →Common questions about changing a registered medical device in Turkey. Each question separates published rules from details still awaiting verification.
- Does changing a device brand name or logo require an update? →Source-linked rules available
- How do I update a manufacturer's name without changing the legal entity? →Source-linked rules available
- What changes when the manufacturer's office address changes? →Source-linked rules available
- Does a catalogue or reference code change affect registration or UDI? →Source-linked rules available
- Can a registration transfer to a different legal entity? →Source-linked rules available
- Can several changes be filed together? →Source-linked rules available
Structured regulatory requirements
Explore all 79 source-linked facts →23 of 25 research dimensions currently covered · 16 official sources · latest verification 2026-10-21
Market entry
Verified
Open details →
D02
Legal basis & guidance
- Entry into force and repeal (MD Regulation)
- The Medical Device Regulation's other provisions entered into force on 26 May 2021 and it repealed the 2011 MDD based Tıbbi Cihaz Yönetmeliği and the Active Implantable Devices Regulation (…
- Legal basis of the Medical Device Regulation
- The Tıbbi Cihaz Yönetmeliği (RG 02.06.2021, No. 31499 Mükerrer) was prepared on the basis of Article 4 of Law No. 7223 (Product Safety and Technical Regulations Law) and Articles 508 and 79…
8 source-linked facts
Checked 2026-08-25
D03
Device definition & scope
- In-house (health-institution) manufacturing exemption
- Devices manufactured and used within health institutions are exempt from the Regulation's requirements except the Annex I general safety and performance requirements, provided all Madde 5(5…
- Medical device definition
- A medical device is defined (mirroring EU MDR) as an instrument whose principal intended function is not achieved by pharmacological, immunological or metabolic means, covering diagnosis, p…
3 source-linked facts
Checked 2026-08-25
D04
Classification rules
- EU-aligned general medical-device classification.
- Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III
1 maintained scheme
Checked 2026-08-25
D05
Registration pathways
- Conformity-assessment routes by class
- Before placing a device on the market, manufacturers apply the conformity assessment procedures of Annexes IX to XI; class III devices undergo Annex IX assessment (or Annex XI part A plus A…
- Free-sale certificate issued by the Kurum
- For export purposes, on request of a manufacturer or authorised representative established in Turkey, the Kurum issues a serbest satış sertifikası stating the registered workplace and that…
3 source-linked facts
Checked 2026-08-25
D06
Reliance & recognition
- EUDAMED use became mandatory — TİTCK duyuru 2026/KKB-1
- TİTCK duyuru 2026/KKB 1 (04.05.2026, Medical Device Registration and Coordination Department) announces that use of the EUDAMED database system has become mandatory and sets out the effect…
- Presumption of conformity via EU harmonized standards
- Devices conforming to harmonized standards (or relevant sections) whose reference numbers have been published in the Official Journal of the European Union are presumed to conform to the Re…
4 source-linked facts
Checked 2026-09-15
D07
Economic-operator roles
- If the authorised representative changes, document the handover
- The manufacturer, incoming authorised representative and, where practicable, outgoing representative agree the end/start of mandates, last date for the former representative in supplied inf…
- If the authorised representative changes, document the handover
- The manufacturer, incoming authorised representative and, where practicable, outgoing representative agree the end/start of mandates, last date for the former representative in supplied inf…
8 source-linked facts
Checked 2026-10-21
D08
Establishment, import & distribution
- Sales-center authorization by provincial directorate
- Medical device sales centers (satış merkezi) must obtain an authorization certificate (yetki belgesi) from the provincial health directorate (müdürlük): documents are reviewed within 15 bus…
- Sales centers must stop selling unsafe devices
- Sales centers must immediately stop selling devices that the Kurum has announced as unsafe or non compliant within market surveillance and the warning system, return them to the manufacture…
2 source-linked facts
Checked 2026-08-25
D09
Dossier requirements
- UTS document legalization and translation rules
- For importer company registration of declarations of conformity / EU declarations in UTS, the original document must be apostilled by the competent authority of the manufacturer's country (…
- Document authentication and translation require the activation qualification
- The guide describes importer certificate/declaration authentication and Turkish translation procedures and a distinct authorised representative mandate/EUDAMED actor printout route. The man…
2 source-linked facts
Checked 2026-10-21
D10
Official forms & portals
- Local-manufacturer CFS uses the current sample workbook
- For an export CFS requested by a local manufacturer, use ÜTS’s CFS application and the sample Excel downloaded from that application. Populate device barcodes and English product names matc…
- Separate CFS route for a Türkiye-established EU authorised representative
- A foreign manufacturer’s Türkiye established EU authorised representative registered in the specified ÜTS activity category requests the export CFS by an EBS petition. Its product list is a…
4 source-linked facts
Checked 2026-10-21
Submission & evidence
D11
Label, IFU & language
- Align changed identity across labels and declaration
- Labels identify the device name or trade name and the manufacturer’s name, registered trade name or trademark and registered business address; an authorised representative is identified whe…
- Declaration of conformity translation
- Where the EU declaration of conformity is drawn up in other languages, a Turkish translation must be annexed to it.
6 source-linked facts
Checked 2026-10-21
D12
QMS, audit & inspection
- Notified-body designation oversight
- The Kurum designates Turkish notified bodies and withdraws the designation if the notified body ceases its activities; notified body identification data follow the EU NANDO references (Madd…
1 source-linked fact
Checked 2026-08-25
D13
Standards, testing & ancillary approvals
- Medical-device CE conformity
- Electrical safety
- Radio Equipment Regulation CE conformity
- Wireless / radio
- BTK market surveillance
- Wireless / radio
4 maintained overlays
D14
Fees
- Medical-device product registration
- TRY 201–335
- Medical-device document registration - EC certificate or declaration of conformity
- TRY 335
18 maintained fee lines · 1 related fact
Checked 2026-08-25
D15
Review clocks
- Class I (non-sterile, non-measuring, non-reusable) · Self-declaration, then ÜTS registration
- 0 days
1 maintained pathway · 4 related facts
Checked 2026-10-21
D16
Approval validity & renewal
- Separate existing placed stock from further legacy placing
- The transitional provisions allow devices lawfully placed on the market under the applicable legacy provisions to continue being made available or put into service. Further legacy placing r…
- Separate existing placed stock from further legacy placing
- The transitional provisions allow devices lawfully placed on the market under the applicable legacy provisions to continue being made available or put into service. Further legacy placing r…
3 source-linked facts
Checked 2026-10-21
Lifecycle & post-market
D17
Change control
- CFS grouping, copies and the state at issuance
- A CFS application contains no more than 1000 devices. Do not mix MDR, IVDR and legacy regime groups; MDR/IVDR products in one application share the same Basic UDI DI. Different destination…
- Notified-body change agreement contents
- Where a manufacturer terminates a notified body contract and contracts another notified body for conformity assessment, detailed arrangements for the change must be clearly defined in an ag…
9 source-linked facts
Checked 2026-10-21
D18
UDI, listing & traceability
- New UDI-DI test for trade name or model changes
- A change that could cause misidentification or ambiguity in traceability requires a new UDI DI, in particular a change in device name/trade name or device version/model. A commercial order…
- New UDI-DI test for trade name or model changes
- A change that could cause misidentification or ambiguity in traceability requires a new UDI DI, in particular a change in device name/trade name or device version/model. A commercial order…
6 source-linked facts
Checked 2026-10-21
D19
Clinical investigation & performance
- Clinical investigation application validation (10 days)
- After receiving an application, the Kurum notifies the sponsor within 10 days whether the clinical investigation falls within the Regulation's scope and whether the application file is comp…
- Ethics committee review
- Clinical investigations are reviewed by an ethics committee from the list established with Kurum approval and published on the Kurum website; at least one lay member serves in the ethical r…
2 source-linked facts
Checked 2026-08-25
D20
Special access & derogation
- Devices without CE mark (custom-made, investigational)
- No barrier is placed on supplying devices without CE marking: investigational devices meeting the conditions of Articles 62 80 and Annex XV, and custom made devices complying with Article 5…
- Public-health waiver
- Upon a duly justified request, the Kurum may permit the placing on the market or putting into service of a specific device in the interest of public health, patient safety or health, in the…
2 source-linked facts
Checked 2026-08-25
D21
Manufacturer PMS
- PSUR update frequency by class
- Manufacturers of class IIb and class III devices update the periodic safety update report at least once per year; class IIa manufacturers update it where needed and at least once every 2 ye…
- Post-market surveillance system part of QMS
- The post market surveillance system is an integral part of the manufacturer's quality management system referred to in Article 10(9).
2 source-linked facts
Checked 2026-08-25
D22
Vigilance & incident reporting
- IVD incident deadlines (conditional)
- Under the IVD Regulation, serious incidents are reported no later than 15 days after the manufacturer becomes aware, and immediately — not more than 2 days — for a serious public health thr…
- MDR-mirrored incident deadlines (conditional)
- Serious incidents must be reported via the electronic system without undue delay and no later than: 15 days after awareness; 2 days for a serious public health threat; 10 days for death or…
3 source-linked facts
Checked 2026-08-25
D23
Recall, FSCA & market surveillance
- Measures for non-compliance without unacceptable risk
- Where a device is non compliant without presenting an unacceptable risk, the economic operator must end the non compliance within a reasonable period; if it does not, the Kurum takes all ap…
- Measures for unacceptable risk
- Where evaluation shows a device presents an unacceptable risk, the Kurum requires the manufacturer, authorised representative and other economic operators, within a reasonable period notifi…
2 source-linked facts
Checked 2026-08-25
D24
Advertising, claims & promotion
- Consumer advertising restrictions and internet-sales channel
- Consumer directed advertising is prohibited for devices sold/applied only in hearing aid centers, custom prosthesis orthesis centers, opticians or dental prosthetics laboratories, and for d…
- Device presentation audience restriction
- Devices may not be presented to persons other than health professionals and technical staff working in medical device fields within health institutions and organizations.
2 source-linked facts
Checked 2026-08-25
D25
Submission communications & appeal
- Objection procedure for clinical investigation decisions
- For clinical investigations, the sponsor may object to Kurum decisions (including validation/scope determinations) through the objection procedure established by the Kurum.
1 source-linked fact
Checked 2026-08-25
Government fees
Full fee schedule (18 lines) →TITCK / UTS registration fees in TRY · reviewed 2026-08-25
| Fee line | Amount | Provenance |
|---|---|---|
| Medical-device product registration | TRY 201–335 | Verified |
| Medical-device document registration - EC certificate or declaration of conformity | TRY 335 | Verified |
| Medical-device and class determination | TRY 51,527 | Verified |
| Free-sale certificate - 1–50 products | TRY 3,349 | Verified |
14 more fee lines on the full schedule · 18 of 18 rows source-verified
Registration timeline
Full registration timeline →Turkish Medicines and Medical Devices Agency (TITCK) review clocks and planning ranges · EU-aligned (I, Is, Im, Ir, IIa, IIb, III) classification
| Class / pathway | Review clock | Planning total | 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 Classes Is, Im and Ir still need a notified body, but only for sterility, the metrological function or reprocessing respectively, and no period binds that assessment TİTCK does not run a product approval at all: the Turkish step is registration of the economic operator and the device in ÜTS, which is a filing rather than a review The sales-centre (satış merkezi) certificate that a Turkish importer or distributor needs is a separate establishment licence, issued in 15 business days with a 45-business-day extension; it is not a device review clock | 0 days | 6-9 months | Verified |
- 1Pre-Submission Preparation(1-3 months)
- 2Application Submission(1-2 weeks)
- 3Administrative Review(2-4 weeks)
- 4Technical Evaluation(0 days)
- 5Registration Approval(1-2 weeks)
Latest regulation news
All Turkey regulation news →Newest official TITCK headlines from the daily-refreshed feed — every row links directly to the authority publication.
Nov 5T/TÄ°TCK / ÃœTSTÄ°TCK Updates Guideline KYS-KLVZ-01 on Communication, Cooperation, and Information Sharing for Medical DevicesTurkeyNov 4T/TÄ°TCK / ÃœTSTÄ°TCK Notice to Medical Device Manufacturers on EUDAMED SS(C)P Management and MDCG GuidanceTurkeyNov 2T/TÄ°TCK / ÃœTSTITCK Announcement 2026/KKB-2 on Uploading Manufacturer Declarations and CE Certificates via E-Signature to ÃœTSTurkeyOct 5T/TÄ°TCK / ÃœTSTITCK Issues Regulatory Notice on Market Surveillance and Vigilance for Medical Devices and IVDsTurkey
TurkeyNov 4T/TÄ°TCK / ÃœTSTÄ°TCK Notice to Medical Device Manufacturers on EUDAMED SS(C)P Management and MDCG GuidanceTurkeyNov 2T/TÄ°TCK / ÃœTSTITCK Announcement 2026/KKB-2 on Uploading Manufacturer Declarations and CE Certificates via E-Signature to ÃœTSTurkeyOct 5T/TÄ°TCK / ÃœTSTITCK Issues Regulatory Notice on Market Surveillance and Vigilance for Medical Devices and IVDsTurkeyKey regulations
All 5 Turkey regulations →Official TITCK rules and guidance · 5 of 5 documents linked to official sources
IVD Medical Device Regulation, Official Gazette No. 31499İn Vitro Tanı Amaçlı Tıbbi Cihaz Yönetmeliği — consolidated national body
GeneralVerifiedFormal annexes to the Türkiye IVD Medical Device RegulationFormal annexes to the Türkiye IVD Medical Device Regulation
GeneralVerifiedFormal annexes to the Türkiye Medical Device RegulationFormal annexes to the Türkiye Medical Device Regulation
GeneralVerifiedMedical Device Regulation, Official Gazette No. 31499Tıbbi Cihaz Yönetmeliği — consolidated national body
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