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 market accessTurkey medical device registration resources
Research TITCK registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Turkey medical device resource.
6 free resources23/25 topics with records3 regulations trackedAug 2026 fees reviewed
Everything we track for Turkey
Browse by resource instead →Medical device regulations
Browse official TITCK regulations and guidance documents.
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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 56 source-linked facts →23 of 25 research dimensions currently covered · 14 official sources · latest verification 2026-09-15
Market entry
Verified
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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- The Medical Device Regulation's other provisions entered into force on 26 May 2021 and it repealed the 2011 MDD based Tıbbi Cihaz Yönetmeliği and the Active Implantable Devices Regulation (…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
- China NMPA approval: no recognition regime
- statement: Türkiye's Tıbbi Cihaz Yönetmeliği (national transposition of EU MDR 2017/745) allows a device to be placed on the Turkish market only if it meets the Regulation's requirements, d…
- 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…
4 source-linked facts
Checked 2026-09-15
D07
Economic-operator roles
- Authorised representative
- Non Turkish manufacturers must mandate an authorised representative established in Turkey; the authorised representative provides information to the Kurum in Turkish and/or an EU official l…
- Distributor verification duties
- Before making a device available, distributors verify that it is CE marked with an EU declaration of conformity drawn up, that the manufacturer supplied information accompanies the device,…
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
- Clinical investigations portal (KAP)
- TİTCK operates the clinical investigations portal at kap.titck.gov.tr for clinical investigation submissions under the Medical Device Regulation.
- 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…
2 source-linked facts
Checked 2026-08-25
Submission & evidence
D11
Label, IFU & language
- Declaration of conformity translation
- Where the EU declaration of conformity is drawn up in other languages, a Turkish translation must be annexed to it.
- Electronic IFU permitted for professional users
- The 2026 amendment to the electronic IFU communiqué (RG 22.04.2026, No. 33232) allows instructions for use to be provided electronically instead of paper for professional users, keeps paper…
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
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 carrier application dates
- UDI carrier application dates: non reusable devices — implantable and class III from 26/5/2021, class IIa and IIb from 26/5/2023, class I from 26/5/2025; reusable devices that bear the UDI…
- 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…
3 source-linked facts
Checked 2026-08-25
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) | 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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