In Turkish Law, the Law No 7223 on Product Safety and Technical Regulations (the “Product Safety Law No 7223”) and the Turkish Regulation on Medical Devices (the “Turkish MDR”) are the primary sources of law regarding medical devices.

Under the Turkish MDR, a medical device is any instrument, apparatus, equipment, software, implant, reagent, material or other article designed by the manufacturer – used alone or in combination – for human use whose principal intended action in or on the human body is not achieved by pharmacological, immunological or metabolic means (though such mechanisms may assist it), and which is intended for one or more of the following:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
• investigation, replacement or modification of anatomy or of a physiological or pathological process or state; and
• providing information via in vitro examination of specimens (including organ, blood and tissue donations).

It also covers devices for contraception or supporting conception, and products specifically intended to clean, disinfect or sterilise the above devices.

As a general principle, the devices falling within the definition above are considered as medical devices. “Medical instruments” (eg, surgical, dental, diagnostic tools) are also deemed medical devices.

There are several pieces of legislation applicable to all medical devices, personal protective equipment and medical instruments.

• The Product Safety Law imposes general obligations on economic operators (including manufacturers, authorised representatives, importers, distributors), related to security, conformity, traceability, recall, notification and sanctions.
• The Consumer Protection Law No 6502 (the “Consumer Protection Law”) prohibits misleading consumers, the Consumer Protection Law and Turkish Commercial Code regulate liability from defects (depending on the purchaser), while the Turkish Penal Code includes sanctions against public health endangerment.

The legal framework regarding medical devices (including software) includes:

• Turkish MDR, which aligns with EU Regulation 2017/745;
• Regulation on In Vitro Diagnostic Medical Devices;
• Regulation on Clinical Trials of Medical Devices;
• Regulation on Sales, Advertising and Promotion of Medical Devices;
• other regulation specific to types of medical devices (eg, on Quality Conformity and Control of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Products, or Medical Devices Produced Using Animal-Derived Tissues); and
• other regulation on specific aspects of medical devices (eg, on Technical Services for Medical Devices Used in Provision of Healthcare Services, Communique on Import Controls of Medical Devices).

Classification of medical devices is risk-based.

There are detailed obligations imposed on economic operators to ensure product security and safe use of products. For example, non-Turkish manufacturers of medical devices must appoint a Turkish Authorised Representative. Importers are liable to verify CE marking, Declaration of Conformity (DoC), ÜTS and EUDAMED registration and Turkish labelling.

Software designed to fulfil the role of medical devices adhering to the above definition must meet all requirements of Turkish MDR (classification, ÜTS and EUDAMED registration, clinical trial and assessment, etc), and also meet data privacy requirements. There is no specific regulation on AI products yet, however, there are cybersecurity guidelines applicable across all products.

The main legal source in respect of Personal Protective Equipment (PPE) is the Regulation on Personal Protective Equipment (which transposes EU 2016/425). The general framework above (including Product Safety and Consumer Protection laws) is applicable to PPE products, and compliance with specific PPE legislation is important to avoid recalls and fines.

In practice, this framework means it is important to classify products early, conduct an analysis of product safety requirements, and evaluate the role of any software to be used within/in conjunction with physical products, and ensure awareness on product legislation and obligations. A medical device produced in Turkey, even if not placed on the Turkish market, will need to be compliant with Turkish laws if it will be placed on the European Union market.

Cosmetics

The primary regulation is the Cosmetics Law and the Cosmetics Regulation (aligning with EU Regulation 1223/2009).

The Product Safety Law and Consumer Protection Law are also applicable.

The main authority is the Turkish Medicines and Medical Devices Agency (TİTCK).

A Turkish “Responsible Person” must ensure compliance, keep a Product Information File (PIF) (formula, safety assessment by qualified assessor, GMP evidence, stability, claims substantiation, adverse effects) for ten years. Pre-market electronic notification is made to TİTCK (including information on the product, category and ingredients, including nanomaterials).

There are several lists on restricted/prohibited substances and limitations on the use of colourants, preservatives, UV filters, nanomaterials and others. Claims must meet common criteria (truthful, evidential, honest, fair) and health claims cannot be used for cosmetics products. Adverse effects must be reported.

Biocidal Products

The main regulation on Biocidal Products is the Biocidal Products Regulation. The main authority is the MoH.

There is a two-stage registration process including active substance approval/listing and product authorisation before placing on market (efficacy data, toxicology, risk assessment, analytical methods, labelling drafts).

Product types (PT) classification (disinfectants, preservatives, pest control, etc) applies. No biocidal claims can be used if a biocidal registration is not obtained; the biocidal claim must be used on the label. Labelling in Turkish must include: active substances and concentration, registration number, uses, hazard and precautionary statements, contact info, batch number and expiry date.

Advertising rules apply; advertisements cannot mislead, and no claims can be used beyond registration. Similarly, there are recordkeeping and pharmacovigilance rules applicable, such as adverse incident reporting rules.

Food and Food Supplements

The legal basis for foods and food supplements is the Law No 5996 on Veterinary Services, Plant Health, Food and Feed and the Turkish Food Codex Regulations. These sources regulate ingredients, additives, contaminants, hygiene, labelling, nutrition and health claims.

The authorities involved are two-fold: the Ministry of Agriculture & Forestry (MoAF) and MoH oversee different aspects.

Food business operators are regulated and they must obtain facility registration/approval, comply with HACCP, traceability rules and have recall plans.

Labelling must be in Turkish, and include a nutrition declaration (unless exempt). Nutrition and health claims can only be used in accordance with regulatory conditions; and disease prevention/treatment claims are prohibited.

Food Supplements Regulation regulates pre-market notifications to MoAF, permitted vitamins/minerals/other substances with maximum levels and mandatory disclaimer (“supplement, not a medicinal product...”). Health claims can only be used in cases where they are approved by the MoH.

Foods with Special Medicinal Purposes

Foods with special medicinal purposes are still deemed as foods, but are subject to other regulations such as the Regulation on Licensing of Foods with Special Medicinal Purposes. These products are subject to oversight of the MoH and prior to marketing, and must be registered with the MoH. The Regulation on Market Control of Medicinal Products for Human Use and Foods with Special Medical Purposes is applicable, and manufacturing facilities must meet GMP standards. Unsafe products are subject to recalls under the Recall Regulation. These products cannot be marketed with health claims.

GMOs/Gene Edited

Biosafety Law No 5977 regulates GMOs. Biosafety Board authorisation is required for GMO activities. GMO use in products is subject to approval; use of GMOs and related products in infant formulas, follow-on formulas and infant and young child supplements is banned. It is also prohibited to produce genetically modified plants and animals.

Applicable to all of the above are Product Safety Law No 7223 (regarding economic operator obligations, product safety and potential sanctions such as recall), Consumer Law No 6502 (regarding misleading acts and defects), Advertising Board authorities on oversight of claims, and the Personal Data Protection Law No 6698 (KVKK) (personal data in adverse event/traceability systems).

Pharmaceuticals

The core regulations are Decree Law 663; Law No 1262 on Pharmaceutical and Medical Preparations, the Regulation on Marketing Authorisations of Human Medicinal Products, Regulation on Promotional Activities of Human Medicinal Products, the Regulation on Safety of Medicines (pharmacovigilance); Regulation on Clinical Trials of Medicinal Products for Human Use and GMP/GDP Guidelines, among others.

Any product with pharmacological, immunological or metabolic action intended for diagnosis, prevention or treatment requires a TİTCK marketing authorisation. Unlicensed supply is exceptional and possible on specialist prescription. There are separate avenues for pre-marketing authorisation supply, such as compassionate use and named-patient programmes.

Labelling/leaflets must be in Turkish and include necessary information. ITS serialisation and tracking are mandatory.

Pharmacovigilance requires local QPPV, a risk management plan, PSURs and adverse reaction (ICSR) reporting.

Promotion of pharmaceuticals is highly regulated and restricted to healthcare professionals, samples and donations are limited; inducements and public advertising are prohibited.

Blood Products

Law No 5624 on Blood and Blood Products and the relevant Regulation govern donor selection, collection, mandatory infectious disease testing, processing, storage, distribution, haemovigilance and end-to-end traceability.

Blood establishments need MoH/TİTCK authorisation, quality system, validated pathogen reduction (where applicable) and long retention of records. Donor/recipient adverse reactions are reported through the national haemovigilance system.

Plasma-derived medicinal products (eg, albumin, coagulation factors, IVIG) are separately licensed medicines; additional viral safety validation and plasma source traceability are required.

Psychedelics

Classic psychedelics are restricted under Law No 2313. Manufacture, import, export, distribution, clinical trial supply and storage are limited. The use, prescription and monitoring of narcotic and psychotropic drugs is subject to a special and controlled system overseen by the MoH.

CBD (medicinal use)

Cannabinoids used to fall under narcotics control and were prohibited until Law No 7557 came into force on 24 July 2025. With the new law, medicinal products derived from cannabinoids can be legally produced. Cannabis-derived medicinal products, health and personal care products and supplements can now be licensed by the MoH, subject to tracking systems, and be sold only via pharmacies.

Regulation of Clinical Trials of Medicinal/Biological products

In Turkey, legal regulation of medicinal products and healthcare products is as follows.

• The Turkish Penal Code (Article 90 on trials on humans) prohibits all trials made without obtaining necessary permits from relevant authorities, or made in breach of relevant regulations.
• Clinical trial regulations are differentiated by product groups. These include the Regulation on Clinical Trials of Medicinal Products for Human Use, Regulation on Medical Device Clinical Trials, Regulation on Clinical Investigations of Traditional and Complementary Medicine Practices and the Regulation on Efficacy and Safety Studies and Clinical Trials of Cosmetic Products or Raw Materials.
• For certain clinical trials, MoH approval is necessary in addition to Ethics Committee approval, and in some cases, only the Ethics Committee approval is sufficient.
• ICH GCP and the Helsinki Declaration are applicable.

Product Safety Law No 7223 and the Fundamental Law on Healthcare Services No 3359 are generally applicable. The Regulation on Medical Devices is also applicable where the product is a medical device (which can include cases where the product is a standalone software or a wearable hardware).

The KVKK and secondary legislation is applicable to data privacy issues. This includes requirements to inform users, obtain consent or ensure statutory basis for processing, minimise data and take data safety precautions. Cross-border transfers are limited.

There are several cybersecurity regulations including the risk management (ISO 14971), secure development lifecycle (IEC 62304 for software, 81001 5 1) guidelines, as well as KVKK-adjacent regulations.

Advertising is bound by the Regulation on Sales, Advertising and Promotion of Medical Devices if the product is a medical device, and the Consumer Protection Law for all products sold to consumers.

Medical Apps (Standalone Software)

Software with an intended medical purpose (diagnosis, monitoring, prediction, treatment, alleviation) is deemed a medical device. If medical apps are medical devices, the above requirements regarding medical devices will be applicable to them.

Lifestyle/general wellness (fitness, meditation, step counting) apps are generally outside this definition unless claims imply medical benefit (eg, “detects arrhythmia”).

Clear delineation of intended use and disclaimers avoid up-classification.

Telemedicine

Regulation on Provision of Remote Health Services governs remote care. Telemedicine/remote health care can only be provided by licensed healthcare professionals working on behalf of authorised healthcare institutions.

In the provision of telemedicine services, only software licensed by the MoH can be used. These can be remote health information systems (USBS). Healthcare institutions must notify the USBS they will use to the MoH and obtain Remote Health Activity Authorisations. USBS systems are subject to regulations regarding cybersecurity, data security, safekeeping of patient correspondences and e-Nabız integration. Healthcare professionals can issue e-prescriptions and e-reports using these systems. These regulations also apply to health professionals such as dieticians, clinical psychologists, nurses (lactation consultants, etc), physiotherapists, etc.

Wearables

If intended for medical purposes (eg, continuous ECG, glucose monitoring, sleep apnoea detection) these will be classified as medical devices.

Otherwise, they will be deemed consumer products subject to Product Safety Law No 7223, electromagnetic/radio equipment rules, and the Consumer Law No 6502.

Medical wearables are subject to the same MDR conformity pathway.

Stem Cells

Activities related to the production, import-export and storage-distribution of human tissues and cells are carried out by centres that have obtained an activity permit from the TİTCK. Centres are subject to oversight of the TİTCK, as per the Regulation on the Quality and Safety of Human Tissues and Cells and Related Centres.

Organ and tissue harvesting, storage, grafting and transplantation for treatment, diagnosis and scientific purposes is subject to Law No 2238 on Organ and Tissue Procurement, Storage, Vaccination and Transplantation.

Turkish law does not regulate “borderline” products, and products are instead classified by relevant regulations to find which category they belong to. With regard to medicines, medical devices, PPEs, cosmetics, medicines and food, relevant regulations and authorities differ.

Classification should be made by evaluating issues such as the product’s technology, development purpose, claims used, mechanism of action and active ingredients together. When these factors are taken into account, the product can be classified as medical device, medicine, food supplement, cosmetic, etc. It is not possible for a product to be subject to more than one classification at the same time.

Medical Devices

Pursuant to the Turkish MDR, a manufacturer is “a natural or legal person who manufactures or completely refurbishes a device or who has a device designed, manufactured or completely refurbished and markets this device under its own name or trade mark”.

When placing their devices on the market or putting them into service, manufacturers ensure that the devices are designed and manufactured in accordance with the requirements of the Turkish MDR.

Accordingly, they must:

• establish, document, implement and maintain a risk management system;
• conduct clinical evaluation, including post-market clinical follow-up;
• prepare technical documentation for devices and keep it up-to-date; 
• issue an EU declaration of conformity and affix the CE conformity marking if, as a result of conformity assessment procedures, its devices comply with the requirements;
• maintain the technical documentation, a copy of each relevant certificate, for a period of at least ten years after the last device was placed on the market and make it available to the TİTCK upon request;
• establish, document, implement, maintain, keep up-to-date and continuously improve a quality management system commensurate with the risk class and type of the device;
• implement and keep up-to-date a post-market surveillance system;
• ensure that the relevant information specified in Annex I is provided with the device in Turkish; and
• ensure the details on the label are indelible, easily readable and clearly understandable for the intended user or patient.

Manufacturers who believe or have reason to believe that a device they have placed on the market or put into service does not comply with the Turkish MDR shall immediately take the appropriate corrective action, such as bringing the device into compliance, withdrawing it from the market or recalling it.

Manufacturers shall co-operate with the TİTCK upon request regarding the corrective actions taken to eliminate or, if this is not possible, reduce the risks arising from the devices they place on the market or put into service.

Medicinal Products

Businesses intending to operate manufacturing facilities (in line with the Regulation on Manufacturing Facilities for Human Medicinal Products and GMP Guidelines) must ensure the following.

• Authorisation/manufacturing permit – valid authorisation from TİTCK for each activity (manufacturing, packaging, post-import release, analytical controls) and current scope.
• Good manufacturing practices – establishment of an institutional pharmaceutical quality management system; risk-based approach, pharmaceutical quality manual, regular product quality reviews.
• Adequate personnel – adequately trained staff; serial release by the responsible manager/responsible technical person (QP equivalent); continuous training.
• Facility and equipment – proper layout, environmental control, design/qualification and calibration, cleaning and cleaning validation; prevention of cross-contamination (toxicological risk assessment, limit setting).
• Compliance with other obligations regarding documentation, data integrity, material management, deviation management, in-process controls, critical process validation, analytical method validation, stability programmes and batch traceability.

Telemedicine Platforms/Digital Health Services

Services (not “manufacture”) must be operated by licensed Turkish health institutions; and platform developers (as device manufacturer if software qualifies) shall follow the above-mentioned rules.

Hosting of health data is required to be in Turkey; and cross border transfers are limited under KVKK.

With regard to CSR in Turkey, binding duties arise through environmental, chemicals and waste regimes that apply equally to medical devices, wearables and health products.

For chemicals, KKDIK (REACH-like) registration of substances may be necessary, restricted substances (phthalates, heavy metals) steer material choices and biocides authorisation for certain chemicals apply.

With regard to manufacturing, there may be requirements for Environmental Law 2872 permits and Zero Waste (Sıfır Atık) certification.

With regard to medical waste, there is also separate legislation including the Regulation on Control of Medical Waste, which regulates its collection, separation and destruction.

In Turkey, Consumer Protection Law, Regulation on Commercial Advertisements and Unfair Commercial Practices, and the Turkish Commercial Code set forth the general rules on advertisement and promotions. In addition, for medical devices and healthcare products, there is specific legislation based on product categories. Below is a summary on a product basis.

Medical Devices

As per the regulation on Sales, Advertising and Promotion of Medical Devices, it is prohibited to directly or indirectly advertise devices that should be used or applied exclusively by healthcare professionals to the public through programmes, films, TV shows, news and similar means in all kinds of media and communication media open to public broadcasting, including the internet. The advertisement of certain medical devices can only be made by medical devices sales centres. Other medical devices can only be advertised on the webpage where the product is sold. All claims must be based on product usage instructions. No advertising activities can be carried out in a way that may harm the health and safety of the patient, user and the environment. Devices may not be advertised in a manner that may lead to unfair competition or harm the interests of the user, or by providing untrue, misleading, exaggerated or unverified information.

Pharmaceuticals

Public advertising is prohibited. All claims must be consistent with the approved SmPC and not misleading. Promotion to healthcare professionals is allowed under strict rules: materials require mandatory information (name, active substance, authorisation holder, indications, contraindications, adverse effects, supply classification), must encourage rational use, and prior/retrospective control by the TİTCK may occur. Gifts, benefits, inducements or hospitality to healthcare professionals are tightly restricted (only modest, relevant educational items; no cash equivalents), and samples are limited in quantity, time and tracking, with mandatory adverse event reporting systems.

Cosmetics

Cosmetics advertising in Turkey must use only approved/label information, ensure claims are truthful, evidence based, and may not attribute medicinal/therapeutic, disease prevention or healing properties, mislead about function, safety or environmental benefits, nor use unjustified “free from” or “hypoallergenic” claims without robust proof. Comparative, before/after, scientific or endorsement-style claims (including influencer content) require objective substantiation, no deceptive retouching, clear disclosure of paid sponsorship, and sun protection, “dermatologically tested”, natural/organic, anti-aging or efficacy statements must be supported by appropriate studies while avoiding off-label or exaggerated results. Marketing cannot target or exploit children, must use Turkish where mandatory consumer information appears, and violations can trigger suspension, corrective publication and administrative fines. With regard to advertisements of cosmetics, health claims cannot be used.

Food Products

In Turkey, food (including supplements) advertising is overseen chiefly by the Ministry of Agriculture and Forestry (compliance with Turkish Food Codex/labelling and nutrition health claim communiqués) and the Advertising Board. Food advertisements must be truthful, not misleading, consistent with label information and provide Turkish language text for mandatory consumer information. Food product advertisements may not attribute disease prevention, diagnosis, treatment or cure properties, nor suggest foods/supplements are medicines. The TİTCK has power to authorise the use of health claims in the labelling, promotion or advertisement of food supplements. The TİTCK is also the body that regulates the use of health claims in the labelling, promotion and advertisement of food supplements. Only permitted nutrition and health claims may be used with required wording and proximity of disclaimers (eg, balanced diet statement; supplement not a substitute; daily portion warnings). Comparative or influencer/digital promotions must be evidence based, clearly disclosed, avoid hidden advertising, and violations can trigger suspension, corrective notices and administrative fines. Comparative advertisement is prohibited for food supplement products.

Remote Health Services

The advertisement of healthcare services is prohibited in Turkey, and this also covers remote health services. Only the provision of information limited to services provided, expertise areas, address and contact information is allowed, as well as publishing of content that informs consumers on health.

Medical devices that meet the requirements, when duly procured and properly installed, maintained and used in accordance with their intended use, may be placed on the market or put into service.

In order to be placed on the market, a medical device must meet the general safety and performance requirements set out in the Turkish MDR. Demonstrating compliance with the general safety and performance requirements includes a clinical evaluation. Before placing a device on the market, manufacturers shall carry out an assessment of the conformity of that device in accordance with the relevant conformity assessment procedures set out in the Turkish MDR. The conformity assessment shall be carried out by notified bodies. Medical devices may only be placed on the market if a natural or legal person resident in Turkey is appointed as the responsible person. Medical devices must be notified to the TİTCK via ÜTS prior to marketing.

For cosmetics, relevant regulation requires supply of products in accordance with Consumer Protection Law, compliance with labelling rules, usage and destruction instructions, and provision of other information by the responsible person. Cosmetic products may only be placed on the market if a natural or legal person resident in Turkey is appointed as the responsible person. Cosmetics must be notified to the TİTCK via ÜTS prior to marketing.

For human medicinal products, the TİTCK-provided marketing authorizations are necessary. Only under exceptional circumstances, such as compassionate programs or named-patient programs, can products be provided to the market. Pricing and reimbursement of human medicinal products are subject to separate legislation.

With regard to digital health/remote care services, if the software is a medical device, the medical devices requirements shall apply. In the provision of telemedicine services, software must be licensed by the MoH. These can be remote health information systems (USBS). Healthcare institutions must notify the USBS they will use to the Ministry of Health and obtain Remote Health Activity Authorisations.

Key factors for internationalisation of Turkish medical device, digital health and pharma manufacturers are as follows.

With regard to medical devices, pharmaceuticals and cosmetics, Turkey substantially mirrors EU rules. This convergence facilitates dossier reuse (CTD, CE technical files) for Turkey and the EU. EU-approved devices and healthcare products are taken into account by TİTCK, and filing requirements are similar. TİTCK collaborates with international partners such as EMA and FDA.

The Turkish Personal Data Protection Authority has an agreement in place with the European Commission regarding access to the EUDAMED, in order to have access for the Turkish authority, reviewing registrations and to enable Turkish manufacturers to register. This agreement also regulates privacy obligations with regard to information shared by the European Commission to the TMMDA.

With regard to internationalisation, the EU and Turkey Customs Union eliminates duties on industrial goods once in free circulation. As Turkey is a close neighbour to European countries, “nearshoring” of supply chains is possible and Turkish companies focus on exports to the European Union especially. Turkey also has several other advantages, such as competitive skilled labour, cluster ecosystems, R&D grants and tax and investment incentives.

Jurisdictionally, Turkey is not a member of the European Union, however Turkish laws are frequently similar to European legal systems.

Medical Devices

The Turkish Medical Device Regulation requires manufacturers, importers, distributors or other persons to plan a post-market surveillance system for each device, commensurate with the risk class and appropriate to the type of device. With the post-market surveillance system, the manufacturer collects, records and analyses relevant data on the quality, performance and safety of the device. 

Pursuant to the Regulation on the Procedures and Principles of Market Surveillance and Inspection by the Ministry of Health, medical devices are subject to surveillance and inspection to ensure that they are safe and in compliance with the relevant technical regulation.

According to Article 33 of the Turkish MDR, an electronic system for vigilance and post-market surveillance will be established by the European Commission under EUDAMED.

Accordingly, manufacturers shall report through the “Electronic System for Vigilance and Post-Market Surveillance” to be established by the European Commission:

• any serious adverse events involving devices placed on the market (excluding “expected adverse events” mentioned in the product information); and
• any field safety corrective actions, in relation to devices legally placed on the market in Turkey or EU member states, including those carried out outside these countries.

Manufacturers shall report through the electronic system any statistically significant increase in the frequency or severity of adverse events that are not serious adverse events or are expected unintended side effects that may have a meaningful effect in a benefit-risk analysis and that cause or may cause unacceptable risks to the health and safety of patients, users or other persons compared to the intended benefits.

The TİTCK shall carry out appropriate controls on the suitability of the characteristics and performance of devices, including, where appropriate, documentation review and physical checks based on adequate samples or laboratory tests. In particular, TİTCK takes into account recognised principles on risk assessment and risk management, vigilance data and complaints.

In addition, the TİTCK conducts announced and, if necessary, unannounced inspections at the facilities of economic operators together with suppliers and/or contractors and, where necessary, at the facilities of professional users.

Human Medicinal Products

In accordance with the Regulation on the Safety of Human Medicinal Products, marketing authorisation holders guarantee the safety of the products they place on the market. Marketing authorisation holders are responsible for continuously monitoring the safety of their medicinal products, informing TİTCK of any changes that may affect the benefit/risk assessment of the medicinal product, including prohibitions and restrictions imposed by the competent authorities of other countries where the medicinal product is licensed, and keeping the medicinal product information up-to-date in light of available scientific data.

Marketing authorisation holders shall establish a pharmacovigilance system to carry out pharmacovigilance activities and take necessary measures to minimise and prevent risks by evaluating the information obtained through this system.

Healthcare professionals and healthcare institutions/organisations are obliged to notify TÜFAM of adverse events occurring in patients due to the use of medicinal products.

Pursuant to the Regulation on Market Control of Medicinal Products for Human Use and Foods for Special Medical Purposes, TİTCK organises market control activities for products and active substances on the market at certain intervals.

Registration holders and other institutions/organisations have an obligation to notify the TİTCK if they learn or suspect that a product is defective. For pharmaceuticals determined to be non-compliant by the TİTCK, the withdrawal process defined in the Regulation on the Withdrawal of Human Medicinal Products and Foods for Special Medical Purposes will be applied depending on the nature of the non-compliance.

Cosmetic Products

Through internal market controls, the TİTCK monitors the appropriateness of cosmetic products and sees that they do not endanger human and public health and safety. For this purpose, the TİTCK conducts market surveillance and inspection activities and controls cosmetic products and economic operators on an appropriate scale by relevant physical controls through product information dossiers, as well as where possible, through appropriate samples, and where necessary, laboratory tests.

The TİTCK determines the production site inspections, market surveillance and inspection of cosmetic products and the issues of sampling, warning, withdrawal from the market, destruction, rehabilitation and closure of the production site.

Cosmetic product manufacturers are obliged to collect and record information on the risks and safety of products to ensure product safety. Cosmetic product manufacturers must notify the TİTCK when they encounter a serious unexpected effect due to the use of cosmetic products.

Relevant regulatory authorities are as follows.

• Medicinal products including generics, biologics, advanced therapies and radiopharmaceutical:
1. Turkish Medicines and Medical Devices Agency (TİTCK) – authorisations, GMP, pharmacovigilance, promotion;
2. MoH – central oversight; and
3. Provincial Health Directorates – local inspections.
• Medical devices/in vitro diagnostics/software as a medical device/AI, wearables:
1. TİTCK – classification, conformity assessment oversight, ÜTS registration, vigilance, advertising;
2. MoH/Provincial Health Directorates – facility licences; and
3. Turkish Standards Institution (TSE) – voluntary standards, testing services (notified body functions may be via designated conformity assessment bodies).
• Biocidal products (hand/surface disinfectants, instrument disinfectants):
1. MoH General Directorate of Public Health – product authorisation, surveillance.
• Cosmetics:
1. TİTCK – notification, safety assessments, cosmetovigilance.
• Food supplements/fortified foods/certain nutraceuticals:
1. Ministry of Agriculture and Forestry – pre-market notification, labelling, inspections;
2. Turkish Food and Feed Control Laboratories – analytical testing support; and
3. TİTCK – health claims.
• Telemedicine/digital health service provision:
1. MoH and Provincial Health Directorates – licensing of health institutions, telemedicine circular compliance.
• Pricing and Reimbursement
1. Ministry of Health Pricing Commission; and
2. Social Security Institution (SGK) – reimbursement listing, reference pricing, tenders.
• Advertising/consumer protection/unfair commercial practices/e-commerce:
1. Ministry of Trade;
2. Advertising Board – administrative decisions;
3. RTÜK (Radio and Television Supreme Council) – broadcast ads; and
4. Personal Data Protection Authority – may intersect for targeted advertising.
• Data protection/cybersecurity/cross-border data:
1. Personal Data Protection Authority; and
2. National Cyber Incident Response Center (USOM) under BTK (threat co-ordination).
• Environmental/sustainability, waste, chemicals:
1. Ministry of Environment, Urbanisation and Climate Change – waste management, zero waste, carbon/climate forthcoming; and
2. Turkish Environment Agency (where applicable).
• Customs/trade, export controls:
1. Ministry of Trade – Customs Directorate General; and
2. TÜBİTAK and Ministry of Industry and Technology – export/R&D support.
• Clinical trials/ethics:
1. TİTCK – trial authorisation; and
2. Ethics Committees (institutional or central) – protocol approval.
• Intellectual property (patents, trade marks, designs):
1. Turkish Patent and Trade Mark Office (TürkPatent).
• Competition/antitrust (distribution, pricing practices):
1. Turkish Competition Authority.

Powers of the above-mentioned regulators may vary on the basis of product and non-compliance. Sanctions may include suspension of the placing of products on the market, withdrawal, destruction, suspension of advertising and promotional activities, administrative fines and even imprisonment in cases defined as a crime in the relevant laws.

The third chapter of the Turkish Penal Code regulates “Crimes against Public Health”. Accordingly:

• anyone who sells, supplies or possesses any kind of food or drink or medicines that have been spoiled or altered in a way that endangers the life and health of persons shall be sentenced to imprisonment from one year to five years and a judicial fine up to 1,500 days;
• anyone who manufactures or sells pharmaceuticals in a way that endangers the life and health of persons shall be sentenced to imprisonment from one year to five years and a judicial fine; and
• anyone who manufactures, imports or exports drugs or stimulants without a licence or in violation of a licence shall be sentenced to imprisonment from 20 to 30 years and a judicial fine from 2,000 days to 20,000 days.

According to Law No 1262:

• those who manufacture medicines without a licence, or those who sell, offer for sale or cause such medicines to be sold, shall be punished with imprisonment from one year to five years;
• those who sell, market or advertise any product with the declaration that it diagnoses or treats diseases, although such product is not a pharmaceutical, shall be sentenced to imprisonment from one year to five years; and
• importing pharmaceuticals made outside the Republic of Turkey for commercial purposes without a licence, or selling or offering for sale or having them sold, knowing their properties, is a smuggling offence and is punishable by imprisonment.

Product Safety Law No 7223 imposes administrative fines for violations of technical regulations or general product safety legislation for all products. This fine is increased in case of a serious violation in terms of product safety and public health.

In addition, products placed on the market or kept on the market in violation of the relevant regulations may be confiscated, destroyed or completely stopped from being placed on the market by the relevant ministries; access to websites may be blocked if they are illegally sold and promoted over the internet. Depending on the nature of the violation, the prosecutor’s office may initiate an investigation ex officio.

According to Article 6 of Product Safety Law No 7223, if a product (such as a medicine or medical device) causes damage to a person or property, the manufacturer or importer of that product is obliged to compensate for the damage. In order for the manufacturer or importer to be held liable, the injured party must prove the damage suffered and the causal link between the non-conformity and the damage. The relevant clauses of contracts that relieve the manufacturer or importer from liability for compensation arising from the product or reduce this liability are null and void. Article 6 of Product Safety Law No 7223 and the general provisions of the Turkish Code of Obligations No 6098 (TCO) are also applied together.

There are opinions in legal doctrine that the manufacturers and importers of medical products such as pharmaceuticals and medical devices have “hazard liability”, which is one of the cases of “strict liability” under TCO. However, there is no example reflected in judicial decisions where the manufacturer or importer of pharmaceuticals or medical devices is held liable under the provisions of “strict liability”.

If a product is manufactured defectively, if legal requirements are not complied with during and after the manufacturing phase, if information on how to use the product, possible side effects and risks according to user profiles is not provided, the manufacturer or importer must cover the damages arising from the use of the product.

Since product users are considered “consumers” under Turkish Law, lawsuits must be filed in Consumer Courts. In consumer disputes, the plaintiff is obliged to apply to the mediator before filing a lawsuit. If the plaintiff files a lawsuit without applying to the mediator, their lawsuit will be rejected due to the lack of a cause of action.

The provisions of the Consumer Protection Law and the Turkish Code of Obligations shall apply to lawsuits.

The competent court is determined according to the Code of Civil Procedure. Accordingly, the plaintiff may apply to the court where their domicile is located.

In Turkish Law, strict liability is the exception. The principal rule is fault liability. For such liability to exist, first of all, a damage must have occurred. The person claiming to have suffered damage due to a product must prove that there is a causal link between the damage and the use of the product. The product owner may try to reduce or avoid liability by claiming that it has produced the products in accordance with the legal regulations on the placing of medical products on the market.

Turkey applies a modified loser-pays rule as the losing party reimburses (i) proportional judgment fee (if plaintiff succeeds), (ii) fixed court fees, (iii) litigation disbursements (expert, witness, service, translation), and (iv) a statutory attorney fee at the Bar minimum tariff (not actual billed fees). Partial success causes apportionment of fees.

Consumers are broadly protected as they do not pre-pay proportional decision fees.

Low-value disputes go to Consumer Arbitration Committees. Mandatory mediation (consumer disputes) is a pre-condition; unjustified non-attendance shifts all later costs even if that party prevails.

Security for costs may be ordered against foreign domiciliaries lacking reciprocity.

Other mechanisms available in respect of product-related contentious matters include:

• administrative judicial review (annulment/stay) of TİTCK or Ministry decisions (legal review in accordance with regulations, guidelines and other sources), marketing authorisation refusal, suspension, recall, promotional fines, price/reimbursement listings);
• judicial review of Competition Authority or Advertising Board sanctions (Ankara Administrative Courts; Council of State on appeal);
• review of Social Security Institution (SSI) actions by labour courts (decisions on rejection of applications for reimbursement of medicines and devices critical to human life, such as cancer drugs, by the SSI);
• consumer association “representative actions” to cease unsafe or misleading practices;
• criminal investigations by public prosecutors with forensic autopsy and Turkish Forensic Medicine Institute expert panels after patient deaths allegedly linked to devices/pharmaceuticals;
• mediation (mandatory for consumer/commercial monetary claims) enabling early resolution;
• Ombudsman complaints on maladministration (eg, delay in compassionate use permits); and
• data protection complaints to KVKK Authority (which may influence product design).

The most prominent example is the lawsuits filed in recent years against the SSI’s decisions not to reimburse products that are critical to human life. HPV vaccines or the use of certain cancer products in the treatment of cancer patients at certain stages are excluded from the scope of reimbursement in Turkey. As a result of the lawsuits filed by patients, the decisions of the SSI to deny reimbursement requests are cancelled within the scope of the principle of social state and the “right to a healthy life” within the framework of constitutional rights.

Turkish law does not provide for a class action similar to that of the United Kingdom or the United States of America.

However, the following regulations in the Turkish legal system may be examples of community/group actions.

• Article 73(6) of the Consumer Protection Law – consumer organisations may file a lawsuit in the consumer courts for the elimination of the violation of the law due to the violation of the said law in matters concerning the consumer.
• Article 74(1) of the Consumer Protection Law – consumer organisations have the right to file a lawsuit for the detection of defective goods, the cessation of production or sale, the elimination of the defect, and the recall of the defective goods from those who hold them for sale. Such lawsuits may not include a claim for compensation for damages suffered by consumers.
• Article 56 of the Turkish Commercial Code – chambers of commerce and industry, chambers of artisans, stock exchanges, professional associations, consumer associations and public institutions may file certain lawsuits. The subject matter of these lawsuits may be the determination of whether the act is unfair, the prohibition of unfair competition, the removal of the situation arising as a result of unfair competition, the correction of these statements in case the unfair competition is carried out with false or misleading statements, and the destruction of the means and goods that are effective in the commission of unfair competition when it is inevitable for the prevention of infringement. In the lawsuits to be filed in this way, it is not possible to directly claim the damages of the represented members.
• Article 2 of the Administrative Procedure Law No 2577 – parties whose personal, actual and legitimate interests are violated by an administrative act may file a lawsuit for the annulment of administrative acts. Examples include the annulment lawsuit filed by the Association of Research-Based Pharmaceutical Companies (AİFD) against the decision of the TİTCK on the value of the euro exchange rate used in the determination of pharmaceutical prices, or the lawsuit filed by the Turkish Psychologists Association against the annulment of the regulation regulating the working procedures and principles of psychologists and clinical psychologists.

Turkey has no bespoke product liability ADR scheme, and parties rely on the following.

• Mandatory mediation (pre-condition) for consumer and commercial monetary claims. Mediation is a process under which the parties are free to enter into agreements voluntarily or leave issues to courts; and if an agreement is reached via mediation, the signed agreement will have the power similar to a court decision.
• Consumer Arbitration Committees (below statutory value thresholds) for device/OTC/supplement disputes offer a quick procedure.
• The Insurance Arbitration Commission offers recourse under liability policies.

Liability mechanisms under Turkish law are mutually reinforcing. Regulatory inspections, recalls, pharmacovigilance or vigilance filings generate documents later invoked in civil suits; while non-compliance, late recall or missing traceability can evidence fault and causation, and documented compliance with CE marking, vigilance reporting and risk-benefit evaluations supports a “no defect” defence.

Civil plaintiffs sometimes lodge complaints with prosecutors (product safety) to obtain forensic expert reports and pressure settlement; as criminal findings of defect/negligence are persuasive in civil court.

Turkey is converging with EU frameworks through the implementation of EU MDR/IVDR transitional guidance (UDI database expansion, strengthened post-market surveillance analytics) and the anticipated overhaul of the General Product Safety regime mirroring the EU GPSR. TİTCK digitises vigilance (e-prescribing, adverse event portal) and pilots e-labelling for devices.

Policy debate covers expired medicine take-back and pharmaceutical waste segregation within the national Zero Waste (Sıfır Atık) programme.

Environmental trends include extended producer responsibility expansion, plastic reduction targets, green hospital procurement criteria, life-cycle carbon accounting, recyclable/mono-material packaging, solvent emission controls, ISO 14001 adoption, ESG reporting mandates, and circular economy incentives influencing liability risk assessments.

Turkey underwent a serious reform in 2022 in terms of product safety and technical regulations. In this context, Product Safety Law No 7223 was published and the Turkish Medical Device Regulation was fully harmonised with the European Union regulations.

The Regulation on Promotional Activities of Medicinal Products for Human Use, which regulates the promotional activities of marketing authorisation holders, is expected to be amended in the coming days. In 2024, the draft new regulation was opened for consultation.

In March 2025, a regulation regulating the practice of health professionals such as dieticians, clinical psychologists and physiotherapists was published. Within the scope of this regulation, all healthcare professionals must obtain a licence from health directorates until 31 December 2025. After this licence, if they want to provide remote health services, they must apply to the health directorates and obtain an “online health service permit”. In line with sector demands, the definition of “digital clinic” in the field of digital health is expected to be reflected in the legislation.

AI is reshaping Turkish medical/consumer health products across the lifecycle: research and development including especially molecule/drug research, screening products, demand forecasting, chatbots on apps, counterfeit detection, predictive maintenance of devices, and analytics work, such as real-world evidence analytics supporting reimbursement and other applications are in place or under consideration.

There is no standalone AI Act yet. Anticipated AI legislation may formalise risk classification, bias testing, human oversight, transparency, logging, post-market monitoring and increased recall/liability exposure for non-compliance and accountability.