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
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6 free resources23/25 requirements covered3 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 TİTCK / ÜTS policy, guidance, safety, and compliance updates.
Government registration fees
Review current TİTCK and ÜTS medical-device tariff evidence.
Registration timeline
Which Turkish steps carry a deadline, and why the notified body assessment does not.
Structured regulatory requirements
Explore all 55 source-linked facts →23 of 25 research dimensions currently covered · 14 official sources · latest verification 2026-09-07
Market entry
Verified
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D02
Legal basis & guidance
- 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…
- 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- The Medical Device Regulation's other provisions entered into force on 26 May 2021 and it repealed the 2011 MDD based Tıbbi Cihaz Yönetmeliği and the Active Implantable Devices Regulation (…
8 source-linked facts
Checked 2026-08-25
D03
Device definition & scope
- 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…
- Software and information-society services in scope
- A device supplied to a person via information society services is covered by the Regulation; providers must supply a copy of the EU declaration of conformity on request, and the Kurum may r…
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
- Market-access route (CE + UTS)
- Market access = EU style conformity assessment with CE marking under the Regulation, plus national registration duties in the ÜTS (Ürün Takip Sistemi) imposed on manufacturers, authorised r…
- 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…
3 source-linked facts
Checked 2026-08-25
D06
Reliance & recognition
- 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…
- EU CE under MDR/IVDR — customs union free circulation
- target: geo:tur · sourceApproval: EU CE under MDR/IVDR · edgeType: customs union free circulation · marketAccessStrength: direct with local obligations · regulatoryLayer: product marketing…
3 source-linked facts
Checked 2026-08-25
D07
Economic-operator roles
- Manufacturer quality management system
- Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system ensuring compliance with the Regulation, proportionate to th…
- Manufacturer information/documentation language
- Manufacturers provide, on request, all information and documentation needed to demonstrate device conformity in Turkish and/or the relevant EU official languages.
5 source-linked facts
Checked 2026-08-25
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 (…
1 source-linked fact
Checked 2026-08-25
D10
Official forms & portals
- UTS national registration system and process guide
- The ÜTS (Ürün Takip Sistemi) is the national product tracking infrastructure for devices produced in or imported into Turkey; company, document and device registration processes are governe…
- Clinical investigations portal (KAP)
- TİTCK operates the clinical investigations portal at kap.titck.gov.tr for clinical investigation submissions under the Medical Device Regulation.
2 source-linked facts
Checked 2026-08-25
Submission & evidence
D11
Label, IFU & language
- Implant card language
- Information supplied with implantable devices (implant card) is presented in Turkish and, where necessary, together with its English version.
- Declaration of conformity translation
- Where the EU declaration of conformity is drawn up in other languages, a Turkish translation must be annexed to it.
4 source-linked facts
Checked 2026-08-25
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
Checked 2026-09-07
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 · 1 related fact
Checked 2026-08-29
D16
Approval validity & renewal
- Notified-body certificate validity (max 5 years)
- Certificates issued by notified bodies remain valid for the period specified in the certificate, not exceeding 5 years, and may be extended at the manufacturer's application for additional…
1 source-linked fact
Checked 2026-08-25
Lifecycle & post-market
D17
Change control
- 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…
- Supply-interruption notification duty
- Where a manufacturer (other than for custom made devices) foresees an interruption or cessation of supply of a device, other than for reasons of bankruptcy, that could result in serious har…
2 source-linked facts
Checked 2026-08-25
D18
UDI, listing & traceability
- UDI system scope and Commission database
- The UDI System (established and controlled by the Commission, defined in Annex VI Part C) enables identification of devices other than custom made and investigational devices and facilitate…
- UDI data required in UTS registration
- Device registration in UTS requires mandatory UDI fields, including the UDI issuing agency (UDI Tahsis Kuruluşu) and the UDI DI number; the authorized UDI issuing agencies are GS1, HIBCC, I…
3 source-linked facts
Checked 2026-08-25
D19
Clinical investigation & performance
- 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…
- 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…
2 source-linked facts
Checked 2026-08-25
D20
Special access & derogation
- 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…
- 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…
2 source-linked facts
Checked 2026-08-25
D21
Manufacturer PMS
- 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).
- 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…
2 source-linked facts
Checked 2026-08-25
D22
Vigilance & incident reporting
- 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…
- Operative 2010 warning-system deadlines (medical devices)
- Under the operative 2010 Tebliğ, events in Turkey are reported to the Ministry electronically: immediately for a serious public health threat (2 days where force majeure exists); immediatel…
3 source-linked facts
Checked 2026-08-25
D23
Recall, FSCA & market surveillance
- 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…
- 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…
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 (TİTCK) 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) | 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)
Key regulations
All 3 Turkey regulations →Official TITCK rules and guidance · 3 of 3 documents linked to official sources
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