Turkey

AI Citation Summary

• Country: Turkey
• Product line: Medical devices
• Regulator / source: Regulatory maturity: Medium-high. The regulatory framework is modeled on EU MDR but is independent from the EU and requires separate registration. Enforcement has become increasingly rigorous; the ÜTS traceability system continues to expand its scope.
• Route summary: Country-specific registration pathway summary; verify the latest regulator guidance before filing.
• Typical timeline: Practical registration timeline - Qualifying Class I notification: 2–4 weeks; Class III approval: 9–15 months. Supplementary-information rounds can extend these ranges.
• Key fees: Market characteristics: A middle-income emerging market; medical device market size approximately USD 3–3.5 billion; high import dependency (~70%); domestic manufacturers concentrated in low-risk consumables; high receptiveness to foreign brands; moderate price sensitivity
• Local requirement: Local agent / certificate holder - Yes. A Turkish Authorized Representative is mandatory because a foreign manufacturer cannot register directly. The registration / notification is filed in the manufacturer's name, with the representative serving as the Turkish legal contact.
• Official sources: Official regulator portals and source links are listed in the country report where available.
• Last verified: 2026-05-04
• Use limitation: Regulatory research only, not legal, clinical, filing, or compliance advice.
• Preferred citation: MedTech Atlas

Market Overview

• Population: Approximately 85 million; median age 32; strong growth in healthcare demand
• Healthcare system: The Social Security Institution (SGK, Sosyal Güvenlik Kurumu) mandatory health insurance covers more than 98% of the population; public hospitals are the primary procurement channel; private hospitals are growing rapidly
• Market characteristics: A middle-income emerging market; medical device market size approximately USD 3–3.5 billion; high import dependency (~70%); domestic manufacturers concentrated in low-risk consumables; high receptiveness to foreign brands; moderate price sensitivity
• Regulatory maturity: Medium-high. The regulatory framework is modeled on EU MDR but is independent from the EU and requires separate registration. Enforcement has become increasingly rigorous; the ÜTS traceability system continues to expand its scope.

Quick Reference

Item	Value
Local agent / certificate holder	Yes. A Turkish Authorized Representative is mandatory because a foreign manufacturer cannot register directly. The registration / notification is filed in the manufacturer's name, with the representative serving as the Turkish legal contact.
Practical registration timeline	Qualifying Class I notification: 2–4 weeks; Class III approval: 9–15 months. Supplementary-information rounds can extend these ranges.
Typical total cost	Approximately USD 15,000–35,000 for one Class IIb device, the explicit total budget reference in this page; actual TRY-denominated charges may fluctuate.
Certificate validity / renewal	Class I notifications are indefinitely valid if information is kept current; Class IIa / IIb / III approvals are typically valid for 5 years and should be renewed 6–12 months before expiry.
Primary regulator	Turkish Medicines and Medical Devices Agency (TITCK), under the Ministry of Health; ÜTS is the mandatory product-tracking and registration system.
CE / FDA acceleration	CE is a mandatory prerequisite rather than an optional accelerator; its technical file can be reused with certified Turkish translations. FDA approval does not replace CE and provides no formal TITCK fast track.

Market-Entry Logic

Turkey medical-device entry should be separated into TITCK / UTS regulatory review, classification, local representative / importer, technical file, quality-system evidence, clinical / performance evidence, import, post-market surveillance, reimbursement, procurement and service coverage. For foreign companies, approval is only the compliance entry point; commercial success depends on public procurement, private hospital adoption, distributor coverage, installation / training, service uptime, tenders and reimbursement coding.

Entry layer	Key question	Practical view
Regulatory route	Which product category, risk class, application type, reliance route, or special pathway applies?	Confirm the pathway before translating the dossier; route choice drives evidence, timing, fees, inspections, labelling, and change-control obligations
Local execution	Who holds the registration, imports, answers regulator questions, manages safety reporting, and controls renewals or variations?	Contract structure matters because local agents, sponsors, distributors, or licence holders can control practical market access even when the foreign manufacturer owns the product
Evidence and economics	What clinical, quality, performance, HTA, pricing, and budget-impact evidence is needed?	Registration evidence and payer evidence should be planned together; otherwise approval may be achieved without reimbursement, tender access, or hospital adoption
Channel access	Which payer, hospital, distributor, retail, tender, or private-care channel will create volume?	Start with the channel that matches product value and service burden; premium products often need reference sites before broad tender or retail expansion

Main Players and Channel Map

Type	Representative players	Market meaning
Regulator / review	TITCK / UTS	Determines approval route, technical evidence, inspections, labelling, post-market duties, renewals, and variations
Payment / procurement	SGK reimbursement, public tenders and city hospital PPP networks	Determines reimbursement, tender economics, price ceilings, purchasing lists, and patient affordability
Companies / channels	local manufacturers, importers, UTS-registered distributors, Acibadem, Medical Park, public hospitals and multinational medtech companies	Shows the competitive set, partner universe, distribution power, hospital access points, and local execution benchmarks
End users / buyers	Public hospitals, private hospital groups, specialist centers, laboratories, pharmacies, insurers, and regional distributors	Determine adoption, tender volume, reference cases, service expectations, and receivables risk

Development Trends

1. Approval and access are increasingly separate: Technical approval does not guarantee reimbursement, procurement listing, physician adoption, or patient affordability.
2. Local execution quality is a major differentiator: Strong local regulatory, medical, market-access, distribution, and service teams reduce deficiency, launch, and lifecycle risk.
3. Evidence expectations are rising: Payers and hospitals increasingly ask for comparative clinical value, real-world evidence, budget impact, and operational service data.
4. Pricing pressure is structural: localisation, exchange-rate pressure, SGK pricing, public tender preference, UTS traceability and regional hub positioning are reshaping launch sequencing and product economics.
5. Partner control should be managed early: Contracts should protect dossier access, registration ownership, renewal obligations, safety reporting, inventory, and transition rights.

Regulatory Authority

• Competent Authority: TITCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu — Turkish Medicines and Medical Devices Agency), under the Ministry of Health (T.C. Sağlık Bakanlığı)
• Official portal: https://www.titck.gov.tr / E-submission system: https://ebys.titck.gov.tr
• ÜTS System (Ürün Takip Sistemi — Product Tracking System): https://uts.titck.gov.tr
• Key regulations:
  • Medical Devices Regulation (Tıbbi Cihaz Yönetmeliği, 2021 version, closely aligned with EU MDR 2017/745)
  • IVD Medical Devices Regulation (İVD Yönetmeliği, aligned with EU IVDR 2017/746)
  • Active Implantable Medical Devices Regulation (Aktif İmplante Edilebilir Tıbbi Cihaz Yönetmeliği)
  • TITCK-issued guidance documents and circulars (Kılavuzlar)

Device Classification

Local Classification	Risk Level	EU/FDA Equivalent	Notes
Sınıf I	Low risk	EU MDR Class I / FDA Class I	General devices; most require no pre-market review, but registration is mandatory
Sınıf IIa	Medium-low risk	EU MDR Class IIa / FDA Class II	Notified Body involvement required; TITCK recognizes select EU Notified Bodies
Sınıf IIb	Medium-high risk	EU MDR Class IIb / FDA Class II	More rigorous technical documentation review
Sınıf III	High risk	EU MDR Class III / FDA Class III	Implants and high-risk active devices; longest review period

Classification rules are largely identical to the EU MDR Annex VIII rules (Rules 1–22).

Registration Pathway

Pathway for Foreign Manufacturers

1. Appoint a Turkish Authorized Representative (Yetkili Temsilci)

   • Must be a legal entity registered in Turkey; the representative must be registered with TITCK
   • The representative must hold the relevant license and bears legal liability

2. Obtain CE Marking (required for Class IIa and above)

   • CE marking is a prerequisite for registration, but does not replace Turkish registration
   • The certificate issued by the Notified Body must be current and the NB must be recognized by TITCK

3. Prepare Technical Documentation

   • Technical documentation must comply with EU MDR Annex II/III requirements
   • Key documents require certified Turkish translation

4. Register the Device in the ÜTS System

   • ÜTS (Ürün Takip Sistemi) is a mandatory product tracking system
   • The Authorized Representative or manufacturer registers basic product information in ÜTS
   • A UBB code (Ulusal Barkod Bilgi Bankası — National Barcode Database) is assigned; this is the Turkish local UDI

5. Submit Marketing Notification to TITCK (Piyasaya Arz Bildirimi)

   • Submit application through TITCK's electronic system
   • Class I (excluding sterile, measuring, and reusable surgical instruments): Notification-based; no approval needed before market placement
   • Class IIa/IIb/III: Approval-based; must await TITCK's marketing approval letter

6. Obtain an Import Permit (İthalat İzni)

   • Certain products (particularly Class II and above) require a separate import permit
   • Issued by TITCK; validity period is generally aligned with the registration

7. Customs Clearance

   • Cleared using the TITCK-issued import permit and ÜTS registration information

Key Prerequisites

• Valid CE marking (for Class IIa and above, the NB must be recognized by TITCK)
• Active Authorized Representative (Yetkili Temsilci) agreement
• ISO 13485 certificate (current)
• Turkish-language labeling and Instructions for Use (IFU) ready
• ÜTS system account activated

Registration Dossier Requirements

• ISO 13485 certificate (current; issuing body must be recognized by TITCK — certificates from IAF member bodies are generally accepted)
• Certificate of Free Sale (CFS) (issued by the competent authority in the manufacturer's country; notarization + legalization required)
• EU Declaration of Conformity (DoC) (Turkish version or with certified translation)
• Notified Body certificate (Class IIa/IIb/III; must be current)
• Device description and intended purpose (Turkish translation mandatory)
• Risk management file summary (ISO 14971; summary version acceptable)
• Clinical Evaluation Report (CER) (mandatory for Class IIa and above; Class III must include clinical investigation data or equivalent)
• IFU and labeling (Turkish version; compliant with ÜTS/UBB requirements)
• Letter of Authorization for Authorized Representative (notarized + legalized via consulate or Apostille)
• ÜTS product registration confirmation screenshot
• Manufacturer's business license or proof of legal entity (notarized + legalized)
• Import permit application form (where applicable)

Common pitfall: Many applications are rejected due to poor translation quality or an incomplete legalization chain for the Letter of Authorization. Use a translation agency with proven TITCK experience.

Registration Timelines

Stage	Official Timeframe	Practical Reference
ÜTS product registration	5–10 business days	1–2 weeks (initial account setup may take longer)
Class I notification (non-sterile/non-measuring)	Effective upon submission	2–4 weeks (including document preparation)
Class IIa approval	30–60 business days	3–6 months (including supplementary information rounds)
Class IIb approval	60–90 business days	6–9 months
Class III approval	90–120 business days	9–15 months
Import permit (İthalat İzni)	15–30 business days	1–2 months (run in parallel with registration)

Practical note: The TITCK review clock stops when a request for supplementary information (Eksiklik Yazısı) is issued. For high-risk devices, there may be 2–3 rounds of supplementary information requests, each taking 1–3 months. Actual total timelines may exceed the figures above.

Registration Costs

Item	Estimated Cost (USD)
TITCK official application fee (Class I)	~100–300
TITCK official application fee (Class IIa/IIb)	~500–1,500
TITCK official application fee (Class III)	~1,500–3,000
Import permit fee	~200–500 per batch
Turkish translation (full technical dossier)	3,000–10,000 (depending on volume)
Authorized Representative (Yetkili Temsilci) annual fee	3,000–10,000/year (depending on product complexity)
Notarization + consulate legalization	500–2,000 (depending on number of documents and country)
Local regulatory consultant	2,000–8,000 (depending on complexity)
Total budget reference (Class IIb, single device)	~15,000–35,000

Note: Turkey has high inflation. The above figures are USD reference estimates; actual charges may be denominated in Turkish Lira (TRY) and subject to significant fluctuation.

Local Agent / Marketing Authorization Holder Requirements

• Local agent mandatory: Yes. Foreign manufacturers cannot register directly with TITCK; a Turkish Authorized Representative is required.
• Representative qualifications:
  • Must be a legal entity registered in Turkey (individuals cannot serve as Yetkili Temsilci)
  • Must be registered as an Authorized Representative with TITCK
  • Must employ a responsible person with medical device regulatory knowledge (relevant technical/regulatory background typically required)
  • The representative bears joint legal liability for the device's compliance within Turkey
• Marketing authorization holder rules:
  • Registration/notification is filed in the manufacturer's name; the Authorized Representative serves as the Turkish legal contact
  • Changing the Authorized Representative requires a TITCK variation application with new authorization documents; product supply must not be interrupted during the transition (complete the new representative's registration before terminating the old arrangement)

Import Requirements

• Import Permit (İthalat İzni): Class II and above generally requires a TITCK import permit; applied for per batch or annually; the ÜTS registration number must be provided
• Customs requirements:
  • Customs clearance requires: ÜTS registration confirmation, import permit, commercial invoice, packing list
  • Customs tariff code (GTİP) must accurately correspond to the product category
  • Some products are subject to additional duties (medical device import duty rates range from 0%–18%; certain preferential rates apply)
• Labeling language: Turkish-language labeling is mandatory and must include: manufacturer information, Authorized Representative information, product name (in Turkish), lot/serial number, expiry date, IFU reference, and UBB code

Post-Market Surveillance

• Adverse event reporting (Piyasa Gözetimi ve Denetimi):
  • Serious adverse events must be reported to TITCK within 15 business days
  • Immediately life-threatening events must be reported urgently within 2–3 business days
  • Reports submitted via the TITCK TS-13 system or email
• Recall rules: The manufacturer or Authorized Representative must execute voluntary recalls as required by TITCK and report recall progress; the ÜTS system supports traceability
• Periodic Safety Update Report (PSUR/PMS): High-risk products must maintain a PMS plan and periodic safety update reports per EU MDR requirements; TITCK may request submission
• Market surveillance: TITCK and provincial health directorates (İl Sağlık Müdürlüğü) conduct regular market surveillance; non-compliant products are subject to withdrawal orders

Renewal Requirements

• Registration validity:
  • Class I notifications: Indefinitely valid; information changes require updates
  • Class IIa/IIb/III approvals: Typically 5-year validity
• Renewal timing:
  • Submit renewal applications 6–12 months before expiry
  • Renewal requires resubmission of updated technical documentation, particularly the CE certificate (if renewed)
  • Product information changes in ÜTS must be updated simultaneously
• Variation notifications: Significant design changes, manufacturer changes, and Authorized Representative changes must be reported to TITCK in advance

Special Regulatory Requirements

• UDI / UBB System:
  • Turkey uses the UBB (Ulusal Barkod Bilgi Bankası) as its local UDI system, managed through ÜTS
  • All marketed devices must be assigned a UBB code with basic product data registered in ÜTS (equivalent to the EUDAMED/GUDID function)
  • Class III devices and implants must carry the UBB code (barcode/QR code) on the smallest sales unit
  • The mandatory enforcement schedule is being progressively implemented; consult the latest TITCK announcements
• Local testing:
  • Certain product categories (e.g., IVDs, radiation-emitting equipment) may require local verification testing at TITCK-recognized laboratories in Turkey
  • EMC (electromagnetic compatibility) testing reports included in the CE marking file are generally accepted
• Special category restrictions:
  • Products containing radioactive substances require additional approval from the Nuclear Regulatory Authority (TAEK)
  • Combination products containing drug components require coordination with the Ministry of Health pharmaceutical directorate
  • IVD products are subject to separate regulations with different classification and application procedures
  • Devices containing restricted substances such as DEHP/BPA require additional declarations

Market Access Channels

• Public hospital procurement: The most important channel; entry into the SGK (Social Security Institution) medical device reimbursement list is key. Procurement is conducted through the national healthcare procurement body (SHÇEP/Türkiye Kamu Hastaneleri Kurumu) and provincial health directorates. Inclusion in the SGK reimbursement list (SUT, Sağlık Uygulama Tebliği) is essential for large-scale public hospital procurement.
• Private hospitals/clinics: Account for ~30% of the market and are growing fastest; procurement decisions are more flexible; high receptiveness to new technologies; significant premium pricing opportunity for internationally recognized brands
• E-commerce/distribution: B2B distribution dominates; consumer medical devices (home/consumer-grade) are sold through pharmacies (Eczane) and e-commerce platforms (Hepsiburada, Trendyol, etc.) — ÜTS compliance is required
• Government tenders (İhale): Conducted through the Public Procurement Authority (KİK) platform; valid TITCK registration is required; domestic manufacturers enjoy some preferential policies

Market Entry Strategy

• Recommended approach:

  • High-risk/high-value products (Class IIb/III): Prioritize local distributors with SGK reimbursement list experience and appoint them as Authorized Representative. Start the Turkish registration process immediately after obtaining the EU CE certificate to avoid the Turkish re-approval process being triggered by CE certificate renewal.
  • Low-to-medium risk products (Class I/IIa): The importer may also serve as Authorized Representative, but their TITCK registration status must be confirmed; complete UBB code registration in ÜTS before initiating market promotion.
  • SGK reimbursement list entry: A prerequisite for the public channel; requires separate pricing negotiations; typically adds 6–18 months.

• Key risks:

  1. Translation quality: Errors in Turkish technical documentation translations are the leading cause of rejection; use certified translators with medical device experience
  2. Authorized Representative change: If the distributor becomes insolvent or the relationship is terminated, complete the change promptly; otherwise the product cannot be legally sold
  3. CE certificate expiry: Renew EU NB certificates promptly; Turkish registration depends on a valid CE certificate — once it lapses, Turkish approval must be re-triggered
  4. ÜTS compliance delay: Sales must not commence before product registration in ÜTS is complete, even if TITCK approval has been granted
  5. Currency risk: The Turkish Lira has depreciated significantly; local contracts should be denominated in USD/EUR or include currency adjustment clauses

• Practical tips:

  • The Turkish registration timeline is tied to EU MDR review cycles — start the Turkish application immediately upon receipt of the EU NB certificate to minimize delays between the two
  • TITCK officials may occasionally request a face-to-face meeting in Ankara on technical matters (especially for Class III); the Authorized Representative and the manufacturer's regulatory lead should maintain close coordination
  • SGK reimbursement negotiations require a dedicated local pricing consultant; budget sufficient time and resources
  • The Turkish medical device market is fragmented with many local distributors; use industry associations (e.g., TİSBİD) to screen for quality partners

Leveraging Existing CE / FDA / NMPA Approvals

Quick Reference

Certificate	Acceleration Effect	Primary Mechanism
EU CE (MDR/IVDR)	⭐⭐⭐⭐⭐ (prerequisite)	CE marking is a mandatory prerequisite for Turkish market entry; technical documentation is fully reusable; CE certificate validity is directly linked to Turkish registration
US FDA (510(k)/PMA)	⭐⭐	No formal FDA fast-track mechanism in Turkey; provides some supporting value for products where CE requirements are unclear
China NMPA	⭐	TITCK does not recognize NMPA; essentially no benefit

EU CE (MDR/MDD/IVDR)

• Recognition mechanism: The Turkish medical device regulatory framework is modeled on EU MDR/IVDR. CE marking is a mandatory prerequisite — not merely an accelerator — for importing medical devices into Turkey. Without CE marking, imported devices generally cannot be registered and sold in Turkey (with limited exceptions for special cases). TITCK requires imported devices to hold a valid CE certificate issued by an EU-recognized Notified Body and to be registered in the ÜTS system. The technical documentation requirements are closely aligned with EU MDR Annex II/III, meaning that the full technical documentation package prepared for a CE application (Technical File, risk management report, CER, Declaration of Conformity) can be used directly for the Turkish application, requiring only the addition of certified Turkish translations. The CE certificate's validity period is also a reference used by TITCK to assess registration validity — when a CE certificate lapses, the Turkish registration is at risk.
• Practical effect: For CE certificate holders, the additional work required to enter the Turkish market mainly consists of: (1) appointing a Turkish Authorized Representative (Yetkili Temsilci); (2) providing certified Turkish translations of the technical documentation; (3) completing product registration in ÜTS and obtaining a UBB code; and (4) submitting the marketing notification to TITCK. Overall, the marginal effort for Turkish registration is minimal for CE holders compared to non-CE products; the main bottlenecks are translation and Authorized Representative arrangements, not technical documentation preparation.
• Key considerations: TITCK requires that CE certificates be issued by "TITCK-recognized Notified Bodies." Verify that the NB used appears on TITCK's recognized list (generally consistent with the EU NANDO database, but verify periodically). CE certificates must be renewed promptly upon expiry; once lapsed, the product's Turkish marketing authorization is immediately suspended. TITCK may be slow to respond to CE certificate changes triggered by device modifications; notify the Authorized Representative to update the Turkish registration proactively.

US FDA (510(k) / De Novo / PMA)

• Recognition mechanism: TITCK has no formal mutual recognition agreement with FDA. FDA approval cannot replace a CE certificate or trigger any TITCK registration simplification mechanism. In rare situations — for example, where CE requirements for a specific IVD are unclear or TITCK questions a particular technical standard — FDA approval can be submitted as supplementary evidence of a product's safety and efficacy. However, this depends on the reviewer's discretion and is not a systematic mechanism.
• Practical effect: FDA technical documentation (clinical data, risk analysis, design V&V) can support the preparation of the Turkish technical file in terms of content, but its practical value is limited. The Turkish technical file is essentially a translated CE technical file, not an FDA-format document. FDA approval is a positive commercial signal for distributors and Authorized Representatives, which may assist in commercial negotiations, but it carries no formal regulatory weight.
• Key considerations: If FDA approval documents are submitted as supplementary materials, attach a certified Turkish translation and clearly explain their informational status to avoid creating the impression that FDA approval is equivalent to CE marking.

China NMPA

• Recognition mechanism: TITCK does not recognize NMPA registration certificates. China's regulatory framework has no formal standing within the Turkish system. The core document required by TITCK is the EU CE certificate and its supporting technical documentation; NMPA registration cannot replace or supplement this requirement.
• Practical effect: Essentially no direct value for a Turkish registration application. Chinese clinical data could theoretically supplement the safety data section of the technical file, but TITCK reviewers have very low acceptance of non-EU clinical data and will require an ethnic applicability statement.
• Key considerations: Do not cite NMPA approval as a technical compliance basis in the Turkish application dossier. If the product is marketed in both China and the EU, relevant post-market data (e.g., global PMS data) can be compiled and used in the safety section of the technical file, but must be presented with professional explanatory notes.

Practical Recommendations

1. CE-first strategy: A valid EU CE certificate is the fundamental prerequisite for Turkish registration. Plan the EU MDR registration and Turkish application in coordination — initiate the Turkish application immediately after the CE certificate is issued to minimize the overall market entry timeline.
2. Standardized Turkish translation: Establish a standardized Turkish technical documentation template that is updated in parallel with the CE technical file, preventing the Turkish registration from falling behind when CE documents are updated.
3. CE expiry alert system: Set up CE certificate expiry alerts in your CRM or project management system (recommend 18 months in advance); coordinate with the Authorized Representative to plan Turkish registration renewals in sync with CE renewals.
4. Continuous ÜTS compliance: The ÜTS traceability system requires ongoing post-market tracking of devices (similar to EUDAMED); plan this in parallel with the EU PMS system to avoid additional compliance burdens.
5. Authorized Representative selection: Prioritize Authorized Representative firms familiar with both the EU MDR and TITCK systems, capable of efficiently converting CE application documents into Turkish format and providing one-stop support for ÜTS operation and SGK reimbursement listing.

FAQ

Q: Do foreign manufacturers need a local representative, and who holds the registration?

A: A Turkish Authorized Representative is mandatory because a foreign manufacturer cannot register directly with TITCK. The registration / notification is filed in the manufacturer's name, while the Authorized Representative acts as the Turkish legal contact and bears local compliance responsibilities.

Q: How long does registration actually take in practice?

A: A qualifying Class I notification takes about 2–4 weeks including preparation. Practical references are 3–6 months for Class IIa, 6–9 months for Class IIb, and 9–15 months for Class III. For high-risk devices, supplementary requests stop the review clock and may add 1–3 months per round.

Q: How much should a company budget in total?

A: The page gives an explicit total budget reference of approximately USD 15,000–35,000 for one Class IIb device. This is not an all-class estimate; the component table lists official fees, Turkish translation, annual Authorized Representative service, legalization, and consulting, while actual TRY-denominated charges may fluctuate.

Q: Does an existing CE or FDA approval accelerate TITCK registration, and by how much?

A: CE is a mandatory prerequisite rather than an optional accelerator. Its technical file can be reused with certified Turkish translations, reducing incremental dossier work, but the page gives no fixed time saving and separate Authorized Representative, ÜTS / UBB, and TITCK steps remain. FDA approval provides no formal fast track or simplified pathway.

Q: What is the most common reason an application is delayed or rejected?

A: Turkish translation errors are identified as the leading cause of rejection, and an incomplete legalization chain for the authorization letter is another common reason for return. Supplementary-information requests also stop the TITCK review clock until a response is submitted.

Q: What happens if the manufacturer wants to change its Authorized Representative later?

A: The change requires a TITCK variation application and new authorization documents; the page does not describe the registration as freely transferable. Complete the new representative's registration before ending the old arrangement so legal sales and product supply are not interrupted.

Q: Is a Turkish clinical trial always required, or can existing evidence be used?

A: This page does not state a blanket local-clinical-trial requirement. Class IIa and above require a Clinical Evaluation Report, and Class III requires clinical-investigation data or equivalent; CE dossier materials, including the CER, can be reused with Turkish translation. Certain categories may still require local verification testing.

Q: What language is required for the dossier, labeling, and IFU?

A: Turkish labeling and IFU are mandatory, and key technical-dossier documents require certified Turkish translation. The label must include the product and manufacturer details, Authorized Representative information, traceability information, and the UBB code listed in the import section.

Q: How often is renewal required, and which changes need a separate filing?

A: Class I notifications remain valid indefinitely if their information is updated. Class IIa / IIb / III approvals are typically valid for 5 years and should be renewed 6–12 months before expiry with updated technical documentation. Significant design, manufacturer, or Authorized Representative changes require an advance variation; the page does not define a universal threshold for a wholly new application.

Q: Can FDA approval replace CE marking for Turkish market entry?

A: No. The page treats valid CE marking as the mandatory prerequisite for imported-device registration, subject only to the limited special-case exceptions it notes. FDA approval cannot replace CE or trigger TITCK simplification; at most, it may serve as supplementary technical evidence or a commercial credibility signal.