TITCK · structured requirements

🇹🇷 Turkey IVD regulatory data

Explore the IVD requirements currently available for Turkey, organized by topic and linked to official sources.

17 facts9 dimensions4 official sourceslatest verification 2026-10-21

Changes after registration

Common questions about changing a registered IVD 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

Approval validity & renewal

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

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Separate existing placed stock from further legacy placing

ivd-legacy-stock-conditional-continuation

Fact-level verified

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 remains subject to the relevant class/date, valid-certificate, QMS and application conditions and absence of significant changes in design or intended purpose. This is not a general rename/transfer sell-through grace period or permission to first place changed devices under obsolete labels.

Conditions

Check actual placing date, device class, applicable legacy status, certificate, traceability and affected labels.
No universal stock duration following a brand, manufacturer, REF or legal-person change is established by this transition alone.

Change control

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

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CFS grouping, copies and the state at issuance

cfs-product-regime-basicudi-copy-limits

Fact-level verified

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-specific certificates require separate applications; English copies and an additional Turkish copy attract separate charges. Only devices Registered at the issuance date are included, so complete the affected identity/registration work before relying on the resulting CFS particulars.

Conditions

The former certificate’s eligibility or continued validity after a specific role/identity change is not automatically established.

A true new manufacturer must carry the manufacturer obligations

ivd-new-legal-manufacturer-obligations

Fact-level verified

A distributor, importer or other person making a device available under its own name, registered trade name or trademark assumes manufacturer obligations, except for the stated agreement where the original manufacturer remains identified on the label and responsible. Certificates concern a single manufacturer and identify its registered name/address; revised or reissued certificates identify the earlier certificate and changes. A takeover must therefore be assessed against the actual manufacturer and certificate holder, rather than treated as a simple account rename or automatic inheritance.

Conditions

Actual merger/succession documentation and the applicable certificate/conformity route determine implementation.
Changing only the local authorised representative or importer is a separate role change.

Formal annexes to the Türkiye IVD Medical Device Regulation

Notified-body involvement depends on the actual change

ivd-notified-body-change-review

Fact-level verified

Under Annex IX the manufacturer informs its notified body of planned substantial changes to the approved QMS or device range. Changes to an approved device that may affect safety/performance or conditions of use require the technical-documentation certificate issuer’s approval; the body decides between a new conformity assessment and a certificate supplement. A same-entity office rename/address change is not automatically a factory, design or significant QMS change.

Conditions

Only when that notified-body conformity-assessment route and the relevant change trigger apply.
The IVD reference-laboratory 60-day consultation in Annex IX 4.11 is not a general administrative-change SLA.

Ordinary ÜTS application order and grouping limits

uts-ordinary-document-device-sequence

Fact-level verified

Maintain/register the supporting documents and link the appropriate declaration before the device application. For an ordinary Art 40 application select one declaration of conformity and the associated devices; the limit is 500 device notifications, with the same GMDN for legacy devices and the same Basic UDI-DI for new-regime devices except the stated ITC exception. Sign electronically and pay the applicable application fee before authority-review status. A document application is limited to 5 notifications; payment-required document types enter review after signature and payment. These limits do not authorize arbitrary change bundling or one overall fee/clock.

Conditions

Custom-made/system-procedure-pack applications have a separate maximum 5-device rule.
This is the ordinary document/device sequence; the CFS sequence is different.

ÜTS record updating and the application needed for registration

uts-registration-update-application-route

Fact-level verified

Choose the applicable individual legacy, MDR or IVDR device record route. A device registration/update notification governed by Arts 25–33/37–38 must be submitted for authority assessment under Art 40 to reach Registered status. The guide permits individual entry, so optional bulk-template availability is not required to describe the individual route. Art 35 separately permits specified updates such as catalogue-document association or new product images without an application; it does not equate a changed orderable REF with a catalogue document.

Conditions

Assess the actual changed record fields and applicable conformity/identifier consequences.
Individual entry is not permission to bypass document, UDI or registration requirements.

Dossier requirements

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

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Document authentication and translation require the activation qualification

uts-document-activation-and-translation-limits

Fact-level verified

The guide describes importer certificate/declaration authentication and Turkish translation procedures and a distinct authorised-representative mandate/EUDAMED actor-printout route. The mandate rule is not the same as certificate/declaration legalization. Articles 8,12,15 and 39(4) take effect only when the specified procedures become technically functional in a ÜTS release; other guide provisions take effect at publication. Select the operating document route and its physical-petition requirements accordingly.

Conditions

Use Articles 8, 12, 15 and 39(4) only after the specified procedures become technically functional in the relevant ÜTS release; other guide provisions apply from publication. Article 15 concerns the MDR system/procedure-pack declaration route, rather than a general IVD declaration rule.
A same-entity office update does not automatically require factory-relocation documents.

Economic-operator roles

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

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If the authorised representative changes, document the handover

ivd-authorised-representative-handover

Fact-level verified

The manufacturer, incoming authorised representative and, where practicable, outgoing representative agree the end/start of mandates, last date for the former representative in supplied information, transfer of documents including confidentiality/property rights, and forwarding of later complaints or suspected-incident reports. This handover concerns the authorised representative; it does not itself transfer the manufacturer’s legal responsibility or certificate.

Conditions

Use only if the representative actually changes.

Local company master data and takeover account access

uts-company-account-change-is-role-specific

Fact-level verified

For company transfer/merger, update the authorised signatories and users defined in ÜTS so the company’s ÜTS activities can continue. Changes to responsible manager, company title and address update automatically in ÜTS when updated in ÇKYS. This local firm-data mechanism does not itself establish transfer of a foreign manufacturer’s conformity certificate or responsibilities.

Label, IFU & language

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

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Align changed identity across labels and declaration

ivd-changed-identity-label-doc-alignment

Fact-level verified

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 where applicable. The EU declaration of conformity identifies the responsible manufacturer, device/product or trade name, identification permitting traceability, catalogue reference where relevant and Basic UDI-DI. After an identity change these documents must describe the same responsible person and device.

Conditions

Read under the applicable national MDR/IVDR conformity regime; legacy devices require their applicable legacy documentation.
A logo-artwork change is not by itself proof of a change to the device name or legal manufacturer.

Official forms & portals

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

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Local-manufacturer CFS uses the current sample workbook

cfs-local-manufacturer-current-workbook-route

Fact-level verified

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 matching the registered Turkish names, upload the file and sign/send for authority assessment. Devices must be Registered; Rejected or System-has-individual-product statuses cause rejection. The current application workbook is required for that execution route.

Conditions

Only if an export CFS is requested by the local manufacturer.
The current sample workbook itself must be obtained from the designated application; historical workbook layouts are not certified substitutes.

Separate CFS route for a Türkiye-established EU authorised representative

cfs-turkey-established-euar-pdf-route

Fact-level verified

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 an applicant-prepared PDF containing device barcodes and English names matching ÜTS Turkish names. The authority assesses the application and provides fee instructions; after payment it issues only for devices still Registered at issuance.

Conditions

This requires the actual Türkiye-established EU-AR role. It is not an alternative role that a local manufacturer may select to avoid the sample Excel.

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 (2 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.

Prior approvals and evidence for Turkey (3 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

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

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

Review clocks

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

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CFS assessment precedes fee accrual and payment

cfs-assess-accrue-pay-issue-order

Fact-level verified

For the local-manufacturer CFS, the sequence is upload → electronic signature/send → authority assessment → if suitable, fee accrual/payment reference → institutional payment → issuance. Pay within 10 days or ÜTS cancels automatically. The optional 3-working-day pickup hold follows payment/issuance arrangements; it is not a CFS assessment SLA.

Conditions

Use institutional collection via the stated Halkbank channel; ordinary remittance/EFT cannot be matched.
No universal administrative-change or CFS approval duration is stated by these payment/collection windows.

UDI data timing is not authority review time

ivd-udi-update-clock

Fact-level verified

New UDI-DI data must be available when the device is placed on the market. Where a change does not require a new UDI-DI, the manufacturer updates the relevant UDI-database record within 30 days of the change. The economic operator also updates changed actor-registration information within one week under the relevant actor-registration article. These are data-maintenance duties, not authority variation-approval promises.

Conditions

Apply the relevant registration/database operational and transitional stage; deferred ÜTS document procedures take effect only on the specified technically functional release. These maintenance duties do not set an authority review period.

İn Vitro Tanı Amaçlı Tıbbi Cihaz Yönetmeliği (RG 02.06.2021, No. 31499 Mükerrer, consolidated text)

UDI, listing & traceability

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

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New UDI-DI test for trade name or model changes

ivd-identity-change-new-udi-test

Fact-level verified

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 code must first be mapped to the actual label and declared device identity; it is not automatically a UDI-DI or a model.

Conditions

Applies to devices in the national MDR/IVDR UDI regime; do not substitute this for the applicable legacy barcode route.

Tıbbi Cihazların Ürün Takip Sistemine Kayıt Süreçlerine İlişkin Kılavuz (TCKKD-KLVZ-03), Kılavuz Metni V.4.0, effective 13/05/2026

Record REF and model according to the actual label/documents

uts-identity-and-reference-fields

Fact-level verified

For MDR and IVDR records, enter version/model and reference/catalogue number exactly as declared in the linked documents or label. At least one of those two fields must be populated. If the same declared information serves as model in a document and REF on the label (or conversely), enter it in both fields. UDI-DI must not be entered as either model or reference/catalogue number. Multiple declared reference numbers are recorded as the guide specifies.

Conditions

The guide has a separate Art 25 legacy-device record route.
This rule does not establish that every internal sales code is registered device identity.

Related structured datasets

Classification systems · 1 record

Open Turkey IVD risk classification →

turkey:ivd

Jurisdiction Id

turkey

Domains

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

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Turkey registration →

Country

Turkey

Jurisdiction Id

turkey

Country Code

Flag

🇹🇷

Regulator

Turkish Medicines and Medical Devices Agency

Regulator Abbrev

TITCK

Region

europe

Tier

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

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

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Turkey fees →

Jurisdiction Id

turkey

Country

Turkey

Country Code

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

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

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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Pricing

Changes after registration

Approval validity & renewal

Separate existing placed stock from further legacy placing

Change control

CFS grouping, copies and the state at issuance

A true new manufacturer must carry the manufacturer obligations

Notified-body involvement depends on the actual change

Ordinary ÜTS application order and grouping limits

ÜTS record updating and the application needed for registration

Dossier requirements

Document authentication and translation require the activation qualification

Economic-operator roles

If the authorised representative changes, document the handover

Local company master data and takeover account access

Label, IFU & language

Align changed identity across labels and declaration

Official forms & portals

Local-manufacturer CFS uses the current sample workbook

Separate CFS route for a Türkiye-established EU authorised representative

Reliance & recognition

Turkey approvals and evidence in other markets (2 records)

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

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

Prior approvals and evidence for Turkey (3 records)

CE Mark (EU MDR)

China NMPA approval: no recognition regime

FDA 510(k)/PMA

Review clocks

CFS assessment precedes fee accrual and payment

UDI data timing is not authority review time

UDI, listing & traceability

New UDI-DI test for trade name or model changes

Record REF and model according to the actual label/documents

Related structured datasets

More Turkey medical device resources