{"id":26604,"date":"2023-08-31T12:51:52","date_gmt":"2023-08-31T09:51:52","guid":{"rendered":"https:\/\/www.bicakhukuk.com\/?p=26604"},"modified":"2026-09-01T10:29:23","modified_gmt":"2026-09-01T07:29:23","slug":"medical-device-rules-and-regulations-in-turkey","status":"publish","type":"post","link":"https:\/\/www.bicakhukuk.com\/en\/medical-device-rules-and-regulations-in-turkey\/","title":{"rendered":"Medical Device Law in T\u00fcrkiye: \u00dcTS & Compliance"},"content":{"rendered":"

T\u00fcrkiye regulates medical devices through an EU-aligned, lifecycle-based framework covering product qualification, classification, conformity assessment, market access, distribution, use and post-market control. Compliance does not end when a device receives CE marking or is registered in the Product Tracking System, known as \u00dcTS. Manufacturers and other economic operators must manage regulatory duties throughout the device\u2019s commercial life. <\/span>This guide explains the principal Turkish requirements for manufacturers, authorised representatives, importers, distributors, healthcare institutions, investors and technology companies. It also addresses enforcement, product liability and the contractual allocation of regulatory risk.<\/span><\/p>\n

1. Medical Device Regulation in T\u00fcrkiye<\/span><\/h3>\n

Medical devices range from basic instruments to implants, diagnostic systems, software and connected technologies. Their regulation seeks to protect patients and users while permitting access to innovative products whose benefits and risks have been appropriately evaluated. <\/span>T\u00fcrkiye\u2019s system broadly reflects the structure of the European Union medical-device regime and forms part of the country\u2019s wider medical and healthcare law<\/a> framework. However, market participants must also satisfy Turkish requirements concerning competent-authority interaction, economic-operator registration, \u00dcTS, Turkish-language information, sales channels, advertising and domestic enforcement. EU documentation should therefore be reviewed for its practical use in T\u00fcrkiye rather than assumed to complete every local step.<\/span><\/p>\n

2. The Turkish Regulatory Framework<\/span><\/h3>\n

The principal instruments are the Medical Device Regulation<\/strong><\/a>, published on 2 June 2021, and the In Vitro Diagnostic Medical Device Regulation<\/strong><\/a>, published on the same date. They align the Turkish framework with EU Regulation 2017\/745<\/a> on medical devices and EU Regulation 2017\/746<\/a> on in vitro diagnostic medical devices.<\/span><\/p>\n

The core regulations operate alongside Turkish rules and guidance on clinical investigations, performance studies, sales, advertising and promotion, product registration, vigilance, market surveillance, technical services, and testing, control and calibration. General product-safety, consumer, contract, data-protection and competition rules may also apply.<\/span><\/p>\n

T\u0130TCK regulations, guidance, forms, announcements and lists are living sources. The applicable text and transitional arrangements should be verified for the relevant device and date before a regulatory or commercial decision is made.<\/span><\/p>\n

Transitional provisions require device-specific analysis. Continued reliance on a legacy certificate or an extended transition period depends on the device, certificate, conformity-assessment route and satisfaction of the relevant conditions; it should not be inferred from an EU or Turkish transition announcement alone. T\u0130TCK\u2019s 30 June 2026 announcement concerning Regulations No. 2026\/1359 and 2026\/1451 illustrates why the current position must be checked at the date of supply.<\/span><\/p>\n

3. T\u0130TCK as the Competent Authority<\/span><\/h3>\n

The Turkish Medicines and Medical Devices Agency<\/a>, T\u0130TCK<\/strong>, is the principal competent authority for medical devices. Its functions include regulatory implementation, registration and coordination, oversight of conformity-assessment bodies, vigilance, market surveillance, inspection and enforcement. <\/span>T\u0130TCK operates digital and documentary processes and publishes current guidance, forms, authorised-organisation lists and announcements. In 2026, its medical-device portal included updates concerning \u00dcTS registration, EU transitional developments and testing, control and calibration activities. <\/span>Interaction with T\u0130TCK should distinguish the legal status of each source. A regulation, circular, final guidance document, draft guidance and website announcement do not have identical authority. Businesses should record the source, version and verification date relied upon.<\/span><\/p>\n

4. Is the Product a Medical Device?<\/span><\/h3>\n

The first legal question is whether the product falls within the definition of a medical device or an in vitro diagnostic medical device. Qualification depends principally on the manufacturer\u2019s intended purpose and the product\u2019s principal mode of action, not merely on its technology, marketing name or place of sale. <\/span>Complex questions arise for software, wellness applications, laboratory products, accessories, combination products and products bordering on medicines, cosmetics or general consumer goods. A software tool may be a device where it performs a medical function, while a platform limited to storage or administrative communication may fall outside the device definition. <\/span>Qualification determines the regulatory route. An incorrect decision may affect classification, conformity assessment, claims, registration and enforcement. The manufacturer should document its reasoning and revisit it when the intended purpose, functionality or promotional claims change.<\/span><\/p>\n

5. Medical Device and IVD Classification<\/span><\/h3>\n

General medical devices are classified as Class I, IIa, IIb or III<\/strong>, with regulatory controls increasing according to risk. Classification considers factors such as duration of use, invasiveness, implantation, active operation, anatomical location and the consequences of device failure. <\/span>In vitro diagnostic devices are classified as Class A, B, C or D<\/strong>. Their classification reflects the risks to individuals and public health associated with an incorrect result, the intended population and the diagnostic role of the product. <\/span>Classification is not a marketing choice. It determines the conformity-assessment route, the role of a notified body where required, the depth of technical and clinical documentation and post-market obligations. Borderline or novel products require a reasoned application of the relevant classification rules.<\/span><\/p>\n

6. Manufacturers and Regulatory Responsibility<\/span><\/h3>\n

The manufacturer bears primary responsibility for ensuring that the device is designed, manufactured and monitored in conformity with applicable requirements. Core obligations may include quality management, risk management, technical documentation, clinical or performance evaluation, conformity assessment, corrective action and post-market surveillance. <\/span>The manufacturer must define the intended purpose accurately and ensure consistency across the technical file, labels, instructions, registration data and promotional materials. Product or process changes must be evaluated for their effect on conformity documents, certificates and registrations.<\/span><\/p>\n

The regulatory framework also requires the manufacturer to have available at least one person responsible for regulatory compliance (PRRC)<\/strong> with the expertise required by the applicable Regulation. The precise organisational arrangement may depend on the manufacturer\u2019s size and circumstances, but regulatory responsibility cannot be outsourced entirely to a consultant, distributor or registration service. Contracts should support compliance without obscuring the manufacturer\u2019s statutory duties.<\/span><\/p>\n

7. Foreign Manufacturers and Turkish Authorised Representatives<\/span><\/h3>\n

A manufacturer established outside T\u00fcrkiye must appoint a sole authorised representative established in T\u00fcrkiye where the applicable Regulation requires one. The appointment must be documented through a written mandate defining the representative\u2019s regulatory tasks and access to relevant documentation; a commercial agency or distribution appointment is not, by itself, a compliant regulatory mandate.<\/span><\/p>\n

The authorised representative performs the tasks assigned by the applicable Regulation and written mandate, which may include registration, communications with T\u0130TCK, document availability, vigilance and corrective-action cooperation. Its duties are not identical to those of an importer or commercial distributor, even where one entity performs several roles. Whether the representative bears responsibility in a particular enforcement action or civil claim depends on the governing rule, the mandate and its actual conduct.<\/span><\/p>\n

The agreement should address regulatory cooperation, document access, confidentiality, complaints, incident reporting, field safety corrective action, changes to the device or certificates, termination and the future handling of \u00dcTS records. A change of representative requires advance planning to protect continuity of market access and vigilance responsibilities.<\/span><\/p>\n

8. Importers and Distributors<\/span><\/h3>\n

Importers and distributors must perform the checks allocated to them before making a device available. Depending on their role, these may include verifying CE marking, conformity documents, labelling, instructions, registration information and the identity of the manufacturer and authorised representative. <\/span>They must also preserve traceability, maintain suitable storage and transport conditions, manage complaints and cooperate with corrective actions and competent authorities. A distributor that relabels, repackages or markets a device under its own name may assume additional obligations. <\/span>Commercial agreements should define responsibility for registration, customs documentation, Turkish-language materials, stock quarantine, complaint escalation, recalls and regulatory costs. Contractual allocation does not remove statutory responsibility towards authorities, users or injured persons.<\/span><\/p>\n

9. Conformity Assessment and Notified Bodies<\/span><\/h3>\n

Before placing a device on the market, the manufacturer must complete the conformity-assessment route applicable to the product and its classification. Low-risk devices may permit a greater degree of manufacturer self-declaration, while higher-risk devices generally require the involvement of a notified body<\/strong> designated for the relevant regulatory scope and device category. <\/span>The process may include review of the quality management system, technical documentation, risk controls, clinical evidence and manufacturing arrangements. The certificate\u2019s scope, device coverage, conditions and validity should be checked carefully. <\/span><\/p>\n

A certificate should not be treated as permanently securing market access. Its issuer, designation status, scope, device coverage, conditions and validity must be verified against current official records. Changes in design, intended purpose, manufacturing location, critical suppliers or quality systems may require notification or further assessment. Suspension, restriction, expiry or withdrawal can have immediate effects on supply and registration, while a transitional extension is effective only if all applicable conditions remain satisfied.<\/span><\/p>\n

10. CE Marking and Turkish Market Access<\/span><\/h3>\n

CE marking indicates that the manufacturer has completed the applicable conformity-assessment process and declared conformity with the relevant requirements. It is central to T\u00fcrkiye\u2019s EU-aligned framework, but it should not be described as the only practical step required for Turkish market access. <\/span>The economic operators and device may also need to be registered through \u00dcTS, and Turkish rules on language, importation, sales channels, advertising and traceability must be satisfied. The concepts of placing on the market, making available and putting into service should be distinguished because different duties may attach at each stage. Customs or product-safety controls may apply according to the product and transaction. <\/span>It is equally misleading to describe T\u00fcrkiye as issuing a separate substantive product approval through ordinary \u00dcTS document registration. CE marking and \u00dcTS registration perform different legal functions; neither should be presented as a substitute for the other.<\/span><\/p>\n

11. \u00dcTS Registration and Traceability<\/span><\/h3>\n

The Product Tracking System (\u00dcTS)<\/strong> supports the registration, tracking and regulatory supervision of medical devices and relevant economic operators in T\u00fcrkiye. Processes may include company, user, document and device records, together with product identifiers and links between market participants. <\/span>The party responsible for each record should be determined at the beginning of the Turkish market-access project. Data must remain consistent with conformity documents, labels, certificates and corporate information. Changes to the manufacturer, representative, importer, product identifier or certificate may require updates.<\/span><\/p>\n

\u00dcTS registration is an administrative registration and traceability mechanism. It is not a substantive T\u0130TCK approval, marketing authorisation or governmental guarantee of safety or effectiveness<\/strong>. T\u0130TCK guidance and system requirements evolve, and current instructions should be checked for every application or correction. Users should also distinguish final guidance from consultation drafts, system notices and informal website explanations, recording the version and verification date on which an entry is based.<\/span><\/p>\n

12. Labelling, Instructions and Turkish-Language Requirements<\/span><\/h3>\n

Labels and instructions for use must provide the information required for the device to be identified and used safely for its intended purpose. Required content may include the manufacturer, authorised representative, device identification, intended purpose, warnings, precautions, storage conditions, sterility or single-use information and relevant symbols.<\/span><\/p>\n

Turkish-language requirements must be evaluated for labels, instructions and other information supplied to users. The intended user\u2014healthcare professional, laboratory specialist or patient\u2014affects how information should be presented and understood. <\/span>Electronic instructions may be permissible only within the applicable legal conditions. Importers and distributors should verify that translated materials remain consistent with the manufacturer-approved content and do not introduce broader claims or omit material warnings.<\/span><\/p>\n

13. Clinical Evaluation and Performance Evaluation<\/span><\/h3>\n

Manufacturers of medical devices must establish and maintain clinical evidence sufficient to support conformity with relevant safety and performance requirements. Clinical evaluation is a continuing process that considers available clinical data, scientific literature, investigations and post-market experience.<\/span><\/p>\n

For IVDs, performance evaluation addresses scientific validity, analytical performance and clinical performance as applicable. The evidence must correspond to the intended purpose, claims and target population. <\/span>Reliance on equivalence, literature or existing technology requires documented justification. Evidence should be updated when new safety information, complaints, design changes or post-market data affect the benefit-risk analysis.<\/span><\/p>\n

14. Clinical Investigations and Performance Studies<\/span><\/h3>\n

Clinical investigations of devices and performance studies of IVDs may require ethics review, T\u0130TCK processes and compliance with detailed rules on sponsor responsibilities, investigator qualifications, informed consent, safety reporting, insurance and records. <\/span>The regulatory route depends on the product, study purpose, conformity status and intervention. A study intended to support conformity assessment may follow a different pathway from an academic or post-market project. <\/span>Agreements between sponsors, research institutions, investigators and service providers should allocate responsibilities for submissions, data, safety reporting, monitoring, publication, intellectual property, compensation and termination without contradicting mandatory duties.<\/span><\/p>\n

15. Post-Market Surveillance and Vigilance<\/span><\/h3>\n

Manufacturers must operate a proportionate post-market surveillance system to collect and analyse information about devices placed on the market. Complaints, literature, user feedback, technical service data and safety signals should feed into risk management and corrective action. <\/span>Serious incidents and specified safety matters may require reporting through the applicable vigilance process. Field safety corrective action may include software updates, amended instructions, inspection, modification, exchange, withdrawal or recall. Communications to users must be accurate and coordinated with competent authorities where required. <\/span>Importers, distributors, representatives and healthcare institutions need clear escalation procedures. Delay caused by fragmented contractual relationships can increase patient risk and enforcement exposure.<\/span><\/p>\n

16. Sales, Advertising and Promotion<\/span><\/h3>\n

T\u00fcrkiye regulates medical-device sales centres, responsible personnel and promotional activities through a separate framework. Whether a sales-centre authorisation, responsible manager or sales and promotion personnel requirement applies must be assessed by reference to the device, operator, channel and any applicable exemption; the same conclusion should not be assumed for every product or transaction. <\/span>Advertising and promotional content must remain consistent with the device\u2019s intended purpose and evidence. Claims should not exaggerate performance, conceal risks or suggest approval beyond the legal significance of CE marking and registration. Websites, social media, exhibitions, distributor materials and healthcare-professional communications all require review. <\/span>Medical-device promotion must be distinguished from the rules governing healthcare-service advertising, medicinal-product promotion and general consumer advertising. A campaign may engage more than one regime depending on the product, speaker and claim.<\/span><\/p>\n

17. Testing, Control, Maintenance and Calibration<\/span><\/h3>\n

Initial conformity does not eliminate obligations arising during use. Certain devices require testing, control or calibration by authorised organisations under the applicable Turkish framework. T\u0130TCK publishes current lists and implementation guidance, including a guidance update announced on 27 July 2026. <\/span>Healthcare institutions and device operators should maintain inventories, schedules, service records and evidence of corrective action. Technical service providers must evaluate their own registration, authorisation, personnel and record obligations. <\/span>Failure may affect patient safety, regulatory compliance and liability. In a dispute, it may be necessary to distinguish a manufacturing defect from improper installation, inadequate maintenance, calibration failure, user error or an unauthorised repair.<\/span><\/p>\n

18. Data Protection, Cybersecurity and Connected Devices<\/span><\/h3>\n

Connected devices and medical software may collect, transmit or analyse personal health data. Compliance may therefore require coordination between device regulation, Turkish data-protection law, healthcare-data rules and cybersecurity governance. <\/span>Manufacturers and operators should consider access controls, authentication, encryption, logging, vulnerability management, software updates, third-party components, cloud infrastructure and incident response. A cybersecurity vulnerability may also become a safety and vigilance issue where it can affect device performance or patient care. <\/span>Roles and responsibilities should be defined among manufacturers, healthcare providers, software vendors and service companies. Regulatory compliance documentation should remain consistent with privacy notices, contracts and the actual technical architecture.<\/span><\/p>\n

19. Market Surveillance, Non-Compliance and Enforcement<\/span><\/h3>\n

T\u0130TCK may conduct documentary review, inspection, sampling, testing and other market-surveillance activities. It publishes information concerning unsafe products and products contrary to technical regulations. <\/span>Regulatory findings may lead to correction requests, restrictions, suspension of supply, withdrawal, recall, administrative sanctions or other measures. The response should identify the affected products and batches, assess immediate safety needs, preserve records and coordinate communications across the supply chain. <\/span>Registration in \u00dcTS or the existence of conformity documents does not prevent later enforcement. Authorities may investigate whether the device, documentation and economic operators continue to meet applicable requirements.<\/span><\/p>\n

20. Product Liability and Medical Device Disputes<\/span><\/h2>\n

Device-related harm may generate claims based on product safety, contract, tort, consumer law or healthcare liability, including issues examined in our guide to medical malpractice under Turkish law<\/a>. Depending on the governing cause of action and the facts, potentially relevant parties may include the manufacturer, authorised representative, importer, distributor, healthcare institution, technical service provider and user. Inclusion in the supply chain does not make every participant liable on identical grounds.<\/span><\/p>\n

The investigation should distinguish design, manufacturing and information defects from transport damage, improper storage, maintenance failure, unauthorised modification and clinical misuse. Technical and medical expert evidence is often required to establish defect, causation and damage. <\/span>Regulatory non-compliance may be important evidence but does not resolve every element of civil liability automatically. Conversely, a device may comply formally with registration requirements while a particular unit or use still gives rise to a claim.<\/span><\/p>\n

21. Transactions, Distribution Agreements and Regulatory Due Diligence<\/span><\/h3>\n

Medical-device transactions should address regulatory responsibilities expressly. Distribution and authorised-representative agreements need provisions on registration access, technical documentation, complaints, vigilance, recalls, audits, stock, promotional approval and cooperation after termination. <\/span>Mergers, acquisitions and investments require due diligence on product classification, certificates, \u00dcTS records, quality systems, clinical evidence, complaints, field actions, authority correspondence and critical suppliers. A commercial valuation may be materially affected by a certificate or registration that cannot be transferred or maintained after the transaction. <\/span>Exit planning is particularly important. The parties should determine how records, unsold stock, safety obligations and authority communications will be managed when a relationship ends.<\/span><\/p>\n

22. How B\u0131\u00e7ak Law Firm Assists<\/span><\/h3>\n

B\u0131\u00e7ak Law Firm advises manufacturers, authorised representatives, importers, distributors, healthcare institutions, investors and technology companies on Turkish medical-device law. Our services may include product qualification and classification analysis, market-access planning, regulatory mapping, review of \u00dcTS and T\u0130TCK issues, and drafting or negotiation of distribution and authorised-representative agreements.<\/span><\/p>\n

We also assist with labelling and promotional review, regulatory due diligence, authority correspondence, inspection and enforcement response, vigilance and recall strategy, product-liability claims and commercial disputes. Cross-border matters may require coordination between EU documentation, Turkish operational requirements and contractual arrangements among several economic operators. Related healthcare businesses may also require advice on international medical and health tourism law in T\u00fcrkiye<\/a>.<\/span><\/p>\n

Regulatory advice must be based on the device, intended purpose, classification, documentation and current official sources. Registration or past market presence cannot guarantee continued compliance.<\/span><\/p>\n

23. Conclusion<\/span><\/h3>\n

Medical-device market access in T\u00fcrkiye is not a single registration event. It is a continuing lifecycle process linking qualification, classification, conformity assessment, CE marking, \u00dcTS registration, supply-chain controls and post-market responsibility.<\/span><\/p>\n

Each participant must understand both its statutory role and its contractual relationships. Early regulatory planning can prevent inconsistencies between documents, labels, registrations and commercial practice, while effective post-market systems can protect patients and reduce enforcement and liability risk.<\/span><\/p>\n

This publication provides general information on Turkish law and does not constitute legal, technical or regulatory advice for a particular device. Current official sources and device-specific facts should be reviewed before action is taken.<\/em><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

T\u00fcrkiye regulates medical devices through an EU-aligned, lifecycle-based framework covering product qualification, classification, conformity assessment, market access, distribution, use and post-market control. Compliance does not end when a device receives CE marking or is registered in the Product Tracking System, known as \u00dcTS. Manufacturers and other economic operators must manage regulatory duties throughout the device\u2019s 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