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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.

56 facts23 dimensions8 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Consumer advertising restrictions and internet-sales channel

advertising.consumer-restrictions
Fact-level verified

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 devices intended exclusively for use/application by health professionals; advertising of remaining devices to consumers may only be done in the internet medium where the device is sold; Annex-3 (Ek-3) products (e.g. sensitivity toothpaste, denture-care products, condoms, patient diapers, incontinence products) may be advertised freely to consumers.

Conditions
  • Madde 15(2): Kurum-permitted newspaper/magazine announcements to health professionals announcing market launch are outside the paragraph-1 restrictions.
  • Madde 15(3): advertising must comply with Laws No. 6502 and 6112.
  • Madde 18(1): non-compliant devices may not be sold or advertised (fairs exception).

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority

authority.competent-authority
Fact-level verified

TİTCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu), the Ministry of Health agency defined as 'Kurum' in the regulation, executes the Turkish Medical Device Regulation.

Conditions
  • Applies to medical devices; the parallel IVD Regulation is executed by the same authority (TİTCK).

Baseline fact cited only the UTS application portal; corrected to the executing-authority rule with the regulation as source.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Notified-body change agreement contents

change.nb-transfer-agreement
Fact-level verified

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 agreement between manufacturer, new notified body and (where applicable) previous notified body, covering at minimum certificate invalidity date, use of the previous NB identification number, document transfer (including confidentiality/ownership), handover date of tasks, and the last serial/lot number covered by the previous body.

Supply-interruption notification duty

change.supply-interruption-notification
Fact-level verified

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 harm or a serious risk to patients or public health in Turkey or one or more EU member states, it must inform the Kurum without undue delay (article added by RG-17/8/2024-32635).

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical investigation application validation (10 days)

clinical.application-completeness-validation
Fact-level verified

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 complete per Annex XV Section II; the sponsor may object through the Kurum's objection procedure.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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In-house (health-institution) manufacturing exemption

definition.in-house-manufacturing-exemption
Fact-level verified

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) conditions are met (no transfer to another legal entity; manufacture and use under appropriate quality management systems; further conditions listed in the article).

Conditions
  • Madde 5(4): such devices are deemed to be put into service.
  • The parallel IVD Regulation contains equivalent in-house conditions, stricter for class D (İVTT Madde 6(f)).

Medical device definition

definition.medical-device-principal-function
Fact-level verified

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, prevention, monitoring, treatment or alleviation of disease, etc.

Definition continues with the specific intended-purpose list; the full article mirrors MDR Annex VIII text.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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UTS document legalization and translation rules

dossier.uts-foreign-document-legalization
Fact-level verified

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 (or legalized via Turkish embassy/consulate); e-Apostille is accepted with verification; documents in foreign languages require a sworn translator's Turkish translation; certificates must be e-signed, otherwise a Turkish-notary-certified copy or verification via the notified body's official site or EUDAMED is required.

Guide effective 13/05/2026; first version of this guidance line.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Importer verification duties

roles.importer-verification
Fact-level verified

Before placing a device on the market, importers verify that the device is CE marked, that the EU declaration of conformity has been drawn up, and that an authorised representative has been appointed; importers also verify economic-operator/device registration data in the electronic system within 2 weeks of placing on the market (Madde 30(2)).

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Sales-center authorization by provincial directorate

establishment.sales-center-authorization
Fact-level verified

Medical-device sales centers (satış merkezi) must obtain an authorization certificate (yetki belgesi) from the provincial health directorate (müdürlük): documents are reviewed within 15 business days, an on-site inspection is performed within 45 business days, and deficiencies must be cured within 45 business days of the inspection report; the application includes a commitment to sell only devices registered in the Kurum's registration and information system (Madde 5(2)(ç)) and registered centers must keep their recorded data up to date (Madde 8(4)).

Conditions
  • The authorization certificate is issued after proof of payment of the fee (Madde 7(1)).
  • Applies to sales centers; a sorumlu müdür (responsible manager) requirement applies per the Regulation.

Fees

What regulator fee applies to this class, route, event, and date?

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Domestic-product fee support (40%)

fees.domestic-product-fee-support-40-percent
Fact-level verified

The TİTCK 2026 fee schedule applies a reduced fee ('Türkiye'de Üretilen Ürün Desteği — Evet/%40') for many device-related services when the product is manufactured in Turkey, i.e. a 40% domestic-product support/discount on the corresponding fee.

Fee-exemption/discount condition not expressible as a plain fee row.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Electronic IFU permitted for professional users

label.electronic-ifu-professional-users
Fact-level verified

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 for lay users, adds a definition for fixed-installation devices and links e-IFU information to the UDI database; it entered into force effective from 16/7/2025.

Effective from 2025-07-16

Amendment published on an official Ministry of Health domain; MADDE 1 repeals the second paragraph of the base communiqué's Article 2.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Official forms & portals

Which current form, portal, account, and submission package must be used?

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UTS national registration system and process guide

portal.uts-registration-processes
Fact-level verified

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 governed by the TİTCK guide TCKKD-KLVZ-03, whose legal basis is Madde 34 of the Medical Device Regulation and Madde 32 of the IVD Regulation.

TİTCK describes UTS as tracking devices 'from the production line to the point of sale and use' for domestically produced and imported devices and cosmetics. The UTS application portals (uts.saglik.gov.tr / utsuygulama.saglik.gov.tr) were unreachable from the research environment.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Measures for non-compliance without unacceptable risk

surveillance.non-compliance-measures
Fact-level verified

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 appropriate measures without delay to restrict or prohibit the device's availability or to ensure its recall or withdrawal, and notifies the Commission and authorities.

Measures for unacceptable risk

surveillance.unacceptable-risk-measures
Fact-level verified

Where evaluation shows a device presents an unacceptable risk, the Kurum requires the manufacturer, authorised representative and other economic operators, within a reasonable period notified to them, to carry out appropriate, duly justified corrective actions: bringing the device into conformity, restricting its availability, subjecting it to requirements, withdrawing or recalling it; results are notified to the Commission and other authorities via the electronic system.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Conformity-assessment routes by class

registration.conformity-assessment-routes
Fact-level verified

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 Annex X technical documentation per-device), custom-made and investigational devices excluded.

Conditions
  • Madde 52(4): implantable class IIb (except sutures, staples, dental fillings, brackets, crowns, screws, wedges, plates, wires, pins, clips, connectors) additionally undergo technical-documentation assessment per device.

Free-sale certificate issued by the Kurum

registration.free-sale-certificate
Fact-level verified

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 the CE-marked device may be marketed in Turkey and EU member states; the Basic UDI-DI is stated on the certificate.

Market-access route (CE + UTS)

registration.market-access-route
Fact-level verified

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 representatives, importers, distributors, notified bodies, health institutions and other persons.

Conditions
  • Madde 34(2): the detailed UTS obligations are set out in regulations published by the Kurum (see the TCKKD-KLVZ-03 guide).
  • Madde 30(1): the Kurum may impose additional provisions on economic-operator registration.

Effective from 2021-05-26

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Turkey approvals and evidence in other markets (3 records)

ArmeniaBrazil ANVISA · EU conformity assessment · US FDA · Health Canada · Singapore HSA · UK MHRA · South Korea MFDS · Japan MHLW / PMDA · NMPA · Australia TGA · Türkiye conformity assessment

Prior approval / evidence record

Import of an unregistered device requires proof of authorisation in the country of manufacture or in an IMDRF member country

reliance.origin-country-or-imdrf-authorisation-evidence-for-unregistered-import
Fact-level verified
Statement

A device that has no Armenian state registration can still be imported, but the import (conformity) certificate file must contain a document confirming that the device is authorised for use — state registration or free circulation — in its country of manufacture or in an IMDRF member country, or a reasoned reference to such a document, including a Declaration of Conformity with references to the relevant registers. This is the origin-country free-sale certificate requirement: a Turkish, Korean, Chinese or European exporter must produce its home-country registration/free-sale evidence (or an IMDRF-country equivalent) even though the device is not registered in Armenia. The document is mandatory paperwork; the Armenian expert organisation still examines the file and the Ministry of Health still decides.

Source Approval

Registration / free circulation in the country of manufacture, or in any IMDRF member country — US FDA, EU member states (CE), Japan PMDA, Korea MFDS, China NMPA, Canada, Australia, Brazil, Singapore, UK — evidenced by a registration certificate, free-sale certificate or a Declaration of Conformity with register references

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Import Control

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The obligation attaches to the import (conformity) certificate for devices without Armenian state registration; for devices that do have Armenian state registration the equivalent item is a copy of the Armenian registration certificate, and the origin-country evidence is not required.
  • One of the ten statutory grounds for refusing the import certificate is that the imported device has no Armenian state registration, except in the cases the Law allows (Article 47.2(7)(8)). The origin/IMDRF evidence does not cure that ground where registration was required; it is the supporting document for the unregistered-device import cases the Law permits.
  • The file also requires, for every batch, a quality conformity certificate or equivalent, and the instructions for use or a reference to their electronic version (Annex 2, para. 2(2)(b), (c)).
  • The document list was extended by Government Decree No. 1731-Ն of 12.10.2023 and No. 1619-Ն of 17.10.2024.

Language: Armenian. Verbatim, Government Decree No. 429-Ն of 30.03.2023, Annex No. 2, para. 2(2)(a): "պետական գրանցում չունեցող բժշկական արտադրատեսակների համար՝ ա. բժշկական արտադրատեսակի արտադրող երկրում կամ Բժշկական արտադրատեսակների կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրներում կիրառման թույլտվությունը (պետական գրանցումը, ազատ կիրառումը) հավաստող փաստաթուղթ կամ դրա վերաբերյալ փաստարկված տեղեկանք, այդ թվում՝ բժշկական արտադրատեսակների համապատասխանության հայտարարագիր (Declaration of Conformity) համապատասխան գրանցամատյանների հղումով". Translation: "for medical devices without state registration: a. a document confirming authorisation for use (state registration, free circulation) in the country of manufacture of the medical device or in member countries of the International Medical Device Regulators Forum (IMDRF), or a reasoned reference thereto, including a Declaration of Conformity for the medical device with reference to the relevant registers".

Czech RepublicTürkiye conformity assessment

Prior approval / evidence record

Türkiye CE under aligned MDR/IVDR — customs union free circulation

reliance.reliance-edge-turkiye-ce-to-eu27-approval-turkiye-ce-mdr-ivdr-czechia
Fact-level verified
Target

geo:cze

Source Approval

Türkiye CE under aligned MDR/IVDR

Edge Type

Customs Union Free Circulation

Market Access Strength

Direct With Local Obligations

Regulatory Layer

Product Marketing

Local Application Required

No

Target Decision Retained

No

Conditions
  • medical devices and IVDs subject to route-specific scope
  • certificate duly issued by a Turkish notified body under aligned MDR/IVDR rules

EU-level baseline confirming the edge.

DenmarkTürkiye conformity assessment

Prior approval / evidence record

Türkiye CE under aligned MDR/IVDR — customs union free circulation

reliance.reliance-edge-turkiye-ce-to-eu27-approval-turkiye-ce-mdr-ivdr-denmark
Fact-level verified
Target

geo:dnk

Source Approval

Türkiye CE under aligned MDR/IVDR

Edge Type

Customs Union Free Circulation

Market Access Strength

Direct With Local Obligations

Regulatory Layer

Product Marketing

Local Application Required

No

Target Decision Retained

No

Conditions
  • medical devices and IVDs subject to route-specific scope
  • certificate duly issued by a Turkish notified body under aligned MDR/IVDR rules

Prior approvals and evidence for Turkey (6 records)

TurkeyEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority

CE Mark (EU MDR)

Accepted

Yes

Benefit

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.

Timeline Savings

None published

Tıbbi Cihaz Yönetmeliği (Resmî Gazete 2/6/2021 no. 31499 mükerrer, amended 2022, 2023 and 17/8/2024) — Art. 52 conformity assessment routes and Arts. 70, 75 and 78 clinical investigation deadlines

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

TurkeyEU conformity assessment

Prior approval / evidence record

EU CE under MDR/IVDR — customs union free circulation

reliance.reliance-edge-eu-ce-to-turkiye-approval-eu-ce-mdr-ivdr-turkiye
Fact-level verified
Target

geo:tur

Source Approval

EU CE under MDR/IVDR

Edge Type

Customs Union Free Circulation

Market Access Strength

Direct With Local Obligations

Regulatory Layer

Product Marketing

Local Application Required

No

Target Decision Retained

No

Conditions
  • medical devices and IVDs subject to route-specific scope
  • Turkish UTS, language, economic-operator, and surveillance obligations remain

Confirmed from the Turkish regulation itself: devices must bear the CE mark (Madde 20) and importers/distributors verify CE marking and the EU declaration of conformity (Madde 13(2)/14).

TurkeyEU conformity assessment

Regulatory reference

EUDAMED use became mandatory — TİTCK duyuru 2026/KKB-1

reliance.eudamed-mandatory-2026-uts-effect
Fact-level verified

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 on UTS certificate and device registration processes.

Announcement verified on the official TİTCK activity-area page; the duyuru detail page itself was not reachable (404) from the research environment.

TurkeyNMPA

Regulatory reference

China NMPA approval: no recognition regime

reliance.china-nmpa-no-recognition-route
Pending verification
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, demonstrated through the conformity-assessment procedures of Annexes IX-XI (notified-body involvement for Class IIa and above) and evidenced by CE marking. The Regulation contains no clause recognising, abridging on the basis of, or otherwise giving effect to a non-EU marketing authorisation; a China NMPA registration certificate or Class I filing has no regulatory status in Türkiye, and a Chinese manufacturer must obtain CE certification under the aligned regulation and register in ÜTS/EUDAMED through a Turkish authorised representative/importer.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

turkey

China Classes In Scope

All NMPA classes (Class I filing, Class II/III registration) mapped to Türkiye Class I/IIa/IIb/III; IVDs under the parallel IVD regulation

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Madde 5(1): only devices meeting the Regulation's requirements may be placed on the market or put into service
  • Madde 52(1): manufacturer must carry out conformity assessment per Ek IX-XI before placing on the market
  • Madde 20(1): devices deemed compliant must bear the CE conformity marking per Ek V
  • No article refers to foreign (non-EU) approvals; Madde 8 presumption of conformity relates only to harmonised standards published in the EU Official Journal
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2021-06-02

Source passage: MADDE 5- (1) Usulüne uygun olarak temin edildiğinde ve doğru şekilde kurulduğunda, bakımı yapıldığında ve kullanım amacına uygun şekilde kullanıldığında bu Yönetmeliğin gerekliliklerini karşılayan cihazlar, piyasaya arz edilebilir veya hizmete sunulabilir. [...] MADDE 20 - (1) Ismarlama imal edilen veya araştırma amaçlı cihazlar hariç olmak üzere, bu Yönetmeliğin gerekliliklerine uygun olduğu kabul edilen cihazlar, Ek V'te gösterildiği şekilde CE uygunluk işareti taşır. [...] MADDE 52 – (1) İmalatçılar, bir cihazı piyasaya arz etmeden önce, Ek IX ila Ek XI'de belirtilen ilgili uygunluk değerlendirme prosedürleri uyarınca söz konusu cihazın uygunluğunun değerlendirmesini gerçekleştirir.

TurkeyUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

Yes

Benefit

Usable as supporting technical evidence only. Market entry runs on a CE or Turkish notified-body certificate, and a US clearance substitutes for neither.

Timeline Savings

None published

Tıbbi Cihaz Yönetmeliği (Resmî Gazete 2/6/2021 no. 31499 mükerrer, amended 2022, 2023 and 17/8/2024) — Art. 52 conformity assessment routes and Arts. 70, 75 and 78 clinical investigation deadlines

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

TurkeyEU conformity assessment

Regulatory reference

Review clocks

What review, validation, and applicant stop-clock rules apply?

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Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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Devices without CE mark (custom-made, investigational)

derogation.custom-and-investigational-no-ce
Fact-level verified

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 52(7) and Annex XIII (whose documentation includes the Annex XIII Section 1 declaration).

Conditions
  • In-house health-institution manufacturing is separately exempt under Madde 5(5).

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

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UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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UDI carrier application dates

udi.carrier-application-dates
Fact-level verified

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 carrier on themselves — implantable and class III from 26/5/2023, class IIa and IIb from 26/5/2025, class I from 26/5/2027.

Quoted dates are for reusable devices; the same clause lists the earlier non-reusable dates.

UDI system scope and Commission database

udi.system-scope-and-commission-database
Fact-level verified

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 facilitates traceability; the Commission-established and -operated UDI database is used (Madde 28), and data entry into EUDAMED is performed by the relevant parties (Madde 33).

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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IVD incident deadlines (conditional)

vigilance.ivd-incident-deadlines-conditional
Fact-level verified

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 threat; the report is submitted via the electronic system.

Conditions
  • Legacy IVDD vigilance obligations continue per Madde 1(5)(a) until the electronic-system date.

MDR-mirrored incident deadlines (conditional)

vigilance.mdr-incident-deadlines-conditional
Fact-level verified

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 unexpected serious deterioration of health. FSCAs and recalls are reported before implementation except in emergencies. These Article 85 deadlines apply only from 6 months after the EU OJ notice that the relevant EUDAMED electronic system is functional (Madde 111(1)(a)).

Conditions
  • Effective date conditional per Madde 111(1)(a); until then the 2010 Tebliğ regime applies to medical devices.

Operative 2010 warning-system deadlines (medical devices)

vigilance.operative-2010-teblig-deadlines
Fact-level verified

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); immediately for the other category; 10 days for death or unexpected serious deterioration; 30 days for other situations; based on Law No. 4703.

Conditions
  • Manufacturers, authorised representatives, importers and persons responsible for placing on the market report; firm contact information must be updated within 20 days.
  • Remains the operative medical-device regime while Article 85 is EUDAMED-conditional.

Related structured datasets

Classification systems · 2 records
Open Turkey IVD risk classification →
Id

turkey:ivd

Jurisdiction Id

turkey

Domains
  • ivd
Name

Turkey IVD risk classification

Classes
  • Id

    a

    Label

    IVD Class A

    Normalized Risk Level

    low

  • Id

    b

    Label

    IVD Class B

    Normalized Risk Level

    medium

  • Id

    c

    Label

    IVD Class C

    Normalized Risk Level

    high

  • Id

    d

    Label

    IVD Class D

    Normalized Risk Level

    highest

Regulator

TITCK

Official Domains
  • titck.gov.tr
  • mevzuat.gov.tr
Source Status

official-source-verified

Source Title

Turkish IVD regulation, Madde 49 (classification per Annex VIII)

Source Url

https://www.mevzuat.gov.tr/anasayfa/MevzuatFihristDetayIframe?MevzuatTur=7&MevzuatNo=38658&MevzuatTertip=5

Verified On

2026-08-25

Source Supports
  • ivd-class-axis
  • ivd-classification-rules
Open EU-aligned general medical-device classification. →
Id

turkey:medical-device

Jurisdiction Id

turkey

Domains
  • medical-device
Name

EU-aligned general medical-device classification.

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    is

    Label

    Class Is

    Normalized Risk Level

    low

  • Id

    im

    Label

    Class Im

    Normalized Risk Level

    low

  • Id

    ir

    Label

    Class Ir

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Class IIa

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Class IIb

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    highest

Regulator

TITCK

Official Domains
  • titck.gov.tr
  • mevzuat.gov.tr
Source Status

official-source-verified

Source Title

Turkish medical device regulation, Madde 51 (classification per Annex VIII)

Source Url

https://www.mevzuat.gov.tr/anasayfa/MevzuatFihristDetayIframe?MevzuatTur=7&MevzuatNo=38657&MevzuatTertip=5

Verified On

2026-08-25

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
Open Turkey registration →
Country

Turkey

Jurisdiction Id

turkey

Country Code

TR

Flag

🇹🇷

Regulator

Turkish Medicines and Medical Devices Agency

Regulator Abbrev

TITCK

Region

europe

Tier

3

Risk Classification

EU-aligned (I, Is, Im, Ir, IIa, IIb, III)

Classes
  • Id

    class-i

    Class Name

    Class I (non-sterile, non-measuring, non-reusable)

    Risk Level

    low

    Pathway

    Self-declaration, then ÜTS registration

    Official Timeline
    Min

    0

    Max

    0

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Tıbbi Cihaz Yönetmeliği (Resmî Gazete 2/6/2021 no. 31499 mükerrer, amended 2022, 2023 and 17/8/2024) — Art. 52 conformity assessment routes and Arts. 70, 75 and 78 clinical investigation deadlines

    Url

    https://www.mevzuat.gov.tr/mevzuat?MevzuatNo=38657&MevzuatTur=7&MevzuatTertip=5

    Effective Date

    2021-06-02

    Accessed Date

    2026-08-29

    Realistic Timeline
    Min

    6

    Max

    9

    Unit

    months

    Notes
    • 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
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

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
Prior Approvals
  • Authority

    CE Mark (EU MDR)

    Accepted

    Yes

    Benefit

    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.

    Timeline Savings

    None published

  • Authority

    FDA 510(k)/PMA

    Accepted

    Yes

    Benefit

    Usable as supporting technical evidence only. Market entry runs on a CE or Turkish notified-body certificate, and a US clearance substitutes for neither.

    Timeline Savings

    None published

Local Rep Required

Yes

Local Rep Name

Turkish Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

Not accepted

Registration Validity

Indefinite (registration does not expire)

Last Updated

2026-08-29

Verification Status

partially-verified

Official Sources
  • Title

    Tıbbi Cihaz Yönetmeliği (Resmî Gazete 2/6/2021 no. 31499 mükerrer, amended 2022, 2023 and 17/8/2024) — Art. 52 conformity assessment routes and Arts. 70, 75 and 78 clinical investigation deadlines

    Url

    https://www.mevzuat.gov.tr/mevzuat?MevzuatNo=38657&MevzuatTur=7&MevzuatTertip=5

    Effective Date

    2021-06-02

    Accessed Date

    2026-08-29

Reviewed On

2026-08-29

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by TITCK. Appoint a Turkish Authorized Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to TITCK including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    TITCK reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. TITCK may issue questions.

    Duration

    0 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, TITCK issues Turkey market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Turkey fees →
Jurisdiction Id

turkey

Country

Turkey

Country Code

TR

Authority

TITCK / UTS

Low Risk Local
Min

201

Max

335

Currency

TRY

Per Product

Yes

High Risk Local
Min

201

Max

335

Currency

TRY

Per Product

Yes

Details
  • Id

    device-product-registration

    Item

    Medical-device product registration

    Currency

    TRY

    Amount Local

    335

    Amount Local Min

    201

    Amount Local Max

    335

    Amount Local Formatted

    TRY 201–335

    Frequency

    Per application

    Notes

    The general 2026 fee is TRY 335; the tariff’s 40% domestic-product support column shows TRY 201 when eligible.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    device-document-registration

    Item

    Medical-device document registration - EC certificate or declaration of conformity

    Currency

    TRY

    Amount Local

    335

    Amount Local Formatted

    TRY 335

    Frequency

    Per document

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    device-class-determination

    Item

    Medical-device and class determination

    Currency

    TRY

    Amount Local

    51527

    Amount Local Formatted

    TRY 51,527

    Frequency

    Per device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    free-sale-certificate-1-50-products

    Item

    Free-sale certificate - 1–50 products

    Currency

    TRY

    Amount Local

    3349

    Amount Local Formatted

    TRY 3,349

    Frequency

    Per certificate

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    free-sale-certificate-51-250-products

    Item

    Free-sale certificate - 51–250 products

    Currency

    TRY

    Amount Local

    6634

    Amount Local Formatted

    TRY 6,634

    Frequency

    Per certificate

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    free-sale-certificate-over-250-products

    Item

    Free-sale certificate - over 250 products

    Currency

    TRY

    Amount Local

    9918

    Amount Local Formatted

    TRY 9,918

    Frequency

    Per certificate

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    clinical-investigation-first-non-ce

    Item

    Clinical investigation - first application, device without CE mark (thesis/academic excluded)

    Currency

    TRY

    Amount Local

    57967

    Amount Local Formatted

    TRY 57,967

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    clinical-study-ce-marked

    Item

    Clinical investigation or performance study - CE-marked device

    Currency

    TRY

    Amount Local

    2576

    Amount Local Formatted

    TRY 2,576

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    post-market-study-first-application

    Item

    Post-market clinical study - first application

    Currency

    TRY

    Amount Local

    25763

    Amount Local Formatted

    TRY 25,763

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    clinical-study-change-application

    Item

    Clinical-investigation change application

    Currency

    TRY

    Amount Local

    1094

    Amount Local Formatted

    TRY 1,094

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    mdr-ivdr-exception-application

    Item

    MDR/IVDR conformity-assessment exception application

    Currency

    TRY

    Amount Local

    64408

    Amount Local Formatted

    TRY 64,408

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    certificate-extension-2023-kk-1

    Item

    Certificate-extension application (Communiqué 2023/KK-1)

    Currency

    TRY

    Amount Local

    4637

    Amount Local Formatted

    TRY 4,637

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    announcement-2021-kk-3

    Item

    Announcement application (Communiqué 2021/KK-3)

    Currency

    TRY

    Amount Local

    4637

    Amount Local Formatted

    TRY 4,637

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    sales-center-authorization-certificate

    Item

    Sales-center authorization certificate (Yetki Belgesi)

    Currency

    TRY

    Amount Local

    3617

    Amount Local Formatted

    TRY 3,617

    Frequency

    Per certificate

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    technical-service-first-activity-certificate

    Item

    Technical service - first activity certificate

    Currency

    TRY

    Amount Local

    38645

    Amount Local Formatted

    TRY 38,645

    Frequency

    Per certificate

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    notified-body-initial-or-reappointment

    Item

    Notified body - initial/re-appointment application

    Currency

    TRY

    Amount Local

    257635

    Amount Local Formatted

    TRY 257,635

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    notified-body-assessment

    Item

    Notified body - assessment

    Currency

    TRY

    Amount Local

    772906

    Amount Local Formatted

    TRY 772,906

    Frequency

    Per assessment

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

  • Id

    notified-body-annual-surveillance

    Item

    Notified body - annual surveillance

    Currency

    TRY

    Amount Local

    322044

    Amount Local Formatted

    TRY 322,044

    Frequency

    Annual

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Source Title

    TITCK current 2026 institutional service tariff

    Source Effective Date

    2026-03-23

    Verified On

    2026-08-25

Notes
  • The linked workbook is TITCK’s current 2026 tariff version published 23 March 2026.
  • Personnel-document, training, and other administrative rows remain in the linked tariff.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    TITCK current 2026 institutional service tariff

    Url

    https://titck.gov.tr/storage/Archive/2026/dynamicModulesAttachment/2026FiyatTarifesi23.03.2026_bbf0e454-3672-4419-aabf-17e7ce944fae.xlsx

    Effective Date

    2026-03-23

    Accessed Date

    2026-08-25

  • Title

    TITCK annual institutional service-tariff archive

    Url

    https://www.titck.gov.tr/dinamikmodul/70

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Turkey certifications →
Slug

turkey

Market

Turkey

Confidence

low

Schemes
  • Id

    medical-device-ce-conformity

    Name

    Medical-device CE conformity

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Conformity with EU-harmonised standards whose reference numbers are published in the EU Official Journal creates a presumption of conformity with the Turkish Medical Device Regulation requirements (Madde 8).

    Source Urls
    • https://www.mevzuat.gov.tr/anasayfa/MevzuatFihristDetayIframe?MevzuatTur=7&MevzuatNo=38657&MevzuatTertip=5
    Source Binding

    reviewed

  • Id

    radio-equipment-regulation-ce-conformity

    Name

    Radio Equipment Regulation CE conformity

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Source Urls
    • https://btk.gov.tr/yonetmelikler
    Source Binding

    candidate

  • Id

    btk-market-surveillance

    Name

    BTK market surveillance

    Category

    Radio Spectrum

    Status

    Evidence Only No Separate Certificate

    Object

    Radio Equipment

    Source Urls
    • https://btk.gov.tr/yonetmelikler
    Source Binding

    candidate

  • Id

    ministry-authorized-calibration-organizations

    Name

    Ministry-authorized calibration organizations

    Category

    Legal Metrology

    Status

    Mandatory For Use Site

    Object

    Test Control Calibration Organization

    Note

    Kalibrasyon Yönetmeliği (Madde 2): organizations performing test, control and calibration of devices requiring calibration during their use must be authorized by the Ministry; manufacturers', importers', technical services' and users' own activities are out of scope; ionizing-radiation devices are excluded.

    Source Urls
    • https://mevzuat.gov.tr/File/GeneratePdf?mevzuatNo=20855&mevzuatTur=KurumVeKurulusYonetmeligi&mevzuatTertip=5
    Source Binding

    reviewed

Official Sources
  • Authority

    Ministry of Trade

    Topic

    radio equipment product rules

    Url

    https://urunkurallari.ticaret.gov.tr/en/sectoral-guide/communication-technology-telecommunication-and-data-processing

  • Authority

    BTK

    Topic

    regulations including Radio Equipment Regulation

    Url

    https://btk.gov.tr/yonetmelikler

  • Authority

    Mevzuat

    Topic

    Kalibrasyon Yönetmeliği authorized calibration organizations

    Url

    https://mevzuat.gov.tr/File/GeneratePdf?mevzuatNo=20855&mevzuatTur=KurumVeKurulusYonetmeligi&mevzuatTertip=5

  • Authority

    Mevzuat

    Topic

    Medical Device Regulation harmonised standards presumption Madde 8

    Url

    https://www.mevzuat.gov.tr/anasayfa/MevzuatFihristDetayIframe?MevzuatTur=7&MevzuatNo=38657&MevzuatTertip=5

  • Authority

    Ministry of Trade

    Topic

    radiology nuclear medicine radiotherapy device quality control regulation inventory

    Url

    https://urunkurallari.ticaret.gov.tr/tr/sektorel-rehber/tibbi-cihazlar/mevzuat

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