Medtech Lawyer Turkey: Expert Legal Counsel for Medical Device Companies
- Zeynep Atım Kurucuk
- 1 day ago
- 6 min read
The Medtech industry is transforming healthcare as we know it — from wearable monitors that track vital signs in real time to AI-powered diagnostic tools that save lives. But with innovation comes responsibility. Every medical device that reaches patients must comply with strict safety, quality, and regulatory standards. That’s where having the right Medtech lawyer in Turkey becomes essential.
At Kurucuk & Associates, we help Medtech and healthcare companies navigate this complex regulatory world with confidence. Based in Istanbul and deeply experienced in healthcare and life sciences law, our firm advises on everything from medical device registration and CE marking to advertising, distribution, and post-market vigilance.
In Turkey, the Turkish Medicines and Medical Devices Agency (TITCK) oversee the entire process of regulating medical devices. Understanding their rules and expectations is key for success — and mistakes can be costly. Drawing from our real-world experience with manufacturers, distributors, and digital health innovators, this guide will walk you through everything you need to know about Medtech law in Turkey, compliance strategies, and how to protect your business every step of the way.
What Does a Medtech Lawyer in Turkey Do?
The Role of a Medtech Lawyer
A Medtech lawyer isn’t just a legal advisor — they’re your translator between science, technology, and the law. From clinical evaluations to marketing approval, they make sure your innovation is not just brilliant, but also compliant.
At Kurucuk & Associates, we help clients prepare regulatory submissions, review clinical and technical files, structure compliant contracts, and respond to TITCK queries efficiently. Our goal is to simplify what can feel like a maze of legal requirements so you can focus on what truly matters — innovation and patient safety.
Legal Framework Governing Medical Devices
Medical device regulation in Turkey is built upon the TITCK framework, harmonized with the European Union’s Medical Device Regulation (EU MDR 2017/745).To legally sell a device in Turkey, you need CE marking, a Technical File, and often an Authorized Representative within the country.
Kurucuk & Associates assists clients with each of these steps, ensuring smooth compliance with both TITCK and EU standards.
Why Specialized Counsel Is Crucial for Medtech Companies
Medtech law is a blend of science, technology, and strict regulation. A small oversight in labeling, documentation, or post-market surveillance can lead to product recalls, penalties, or loss of authorization. Specialized counsel ensures that your operations are watertight — and your innovation safely reaches the people it was meant to help.
Regulatory Compliance & Market Authorization
Medical Device Registration in Turkey (TITCK Process)
The TITCK registration process requires detailed technical documentation, risk classification, and proof of compliance. A TITCK Registration Lawyer helps ensure every step — from initial submission to final approval — meets Turkish and EU legal requirements.
Our team supports manufacturers through the ÜTS (Product Tracking System), avoiding delays and ensuring transparent communication with regulators.
CE Marking and Technical File Legal Support
CE marking is the passport to the Turkish Medtech market. Our Medical Device Registration Lawyers in Turkey assist in preparing and reviewing Technical Documentation, liaising with Notified Bodies, and verifying CE validity.
We also provide ISO 13485 Legal Support in Turkey, ensuring your Quality Management System aligns with global regulatory standards.
Clinical Evaluation and QMS Requirements
Clinical evaluations prove a product’s safety and performance, while a Quality Management System (QMS) ensures ongoing compliance.
We provide full legal guidance for clinical evaluation reports, biocompatibility studies, and ISO-certified quality systems, safeguarding your path from prototype to market.
Post-Market, Vigilance & Product Liability
Vigilance and Adverse Event Reporting Obligations
Once a product is launched, the responsibility doesn’t end. Turkish law requires prompt reporting of adverse events or safety issues to TITCK.
Our Medical Device Vigilance System Lawyers assist in setting up compliant systems for ongoing monitoring and reporting — protecting patients and your brand alike.
Product Recall & Field Safety Corrective Actions (FSCA)
When safety concerns arise, fast and transparent action is vital. We handle product recalls, FSCA procedures, and regulatory notifications to TITCK, ensuring you meet all obligations without unnecessary reputational harm.
Medical Device Litigation & Liability in Turkey
In case of disputes, Product Liability Lawyers for Medtech at our firm represent both local and international clients in court and arbitration, defending against product defect claims and managing risk exposure effectively.
Commercial & Contractual Legal Support
Drafting Medtech Distribution Agreements
Medtech distribution requires precision and foresight. Our lawyers draft Medical Device Distribution Agreements in Turkey that protect your interests, define roles clearly, and ensure compliance with Turkish and EU trade laws.
Authorized Representative and Importer Responsibilities
Foreign manufacturers must appoint an Authorized Representative in Turkey. We provide end-to-end legal guidance on appointments, liability clauses, and representation requirements to ensure seamless cooperation between you and Turkish authorities.
Advertising and Promotional Compliance
Promoting medical devices in Turkey requires careful attention to TITCK advertising rules. We review all promotional content, ensuring claims are accurate, scientifically supported, and compliant with healthcare advertising regulations.
Medtech Startups, Innovation & IP Protection
Legal Challenges for Medtech Startups and Healthtech Innovators
Turkey’s Medtech startup scene is booming — but early-stage companies face hurdles in licensing, funding, and data protection.
Our Medtech Startup Lawyers in Turkey help you structure your business, secure IP rights, and build investor-ready compliance systems that support long-term growth.
Software as a Medical Device (SaMD) Regulation in Turkey
If your innovation involves software used for diagnosis or therapy, it likely qualifies as Software as a Medical Device (SaMD).We advise startups and established players on Digital Health Regulations in Turkey, guiding them through classification, testing, and TITCK approval.
AI in Healthcare – Legal Framework and Data Protection
Artificial Intelligence is transforming medical practice — but it raises new ethical and legal questions.
Our lawyers counsel clients on AI in Healthcare Legal Issues in Turkey, including data protection, algorithmic accountability, and GDPR compliance under Turkish law.
Why Choose Kurucuk & Associates as Your Medtech Lawyer in Turkey
Proven Experience in Healthcare & Life Sciences
For over two decades, Kurucuk & Associates has been a trusted partner for global Medtech, pharmaceutical, and life sciences companies. We combine legal precision with deep sector insight — from regulatory filings to cross-border compliance.
Deep Knowledge of TITCK and Regulatory Practice
Our team maintains active engagement with the TITCK, staying ahead of policy updates and inspection trends. This firsthand experience allows us to guide clients through complex audits and submissions smoothly.
Client Success Stories & Cross-Border Expertise
We’ve helped clients from Europe, the Middle East, and Asia successfully launch, register, and defend their Medtech products in Turkey.
While confidentiality is paramount, our portfolio includes multinational device manufacturers and pioneering digital health startups expanding into the Turkish market.
Our Credentials:
Years of experience in healthcare and Medtech law
Member of the International Bar Association (IBA) Health Law Section
Certified IAPP professionals for data privacy compliance
Recognized among Turkey’s leading Healthcare Regulatory Law Firms
FAQs about Medtech Legal Services in Turkey
How do I register a medical device with TITCK in Turkey?
You’ll need to submit your product details through TITCK’s ÜTS (Product Tracking System) with your CE certificate, technical documentation, and quality records. A Medtech lawyer can handle the entire process to ensure approval without delays.
What are the penalties for non-compliance with Turkish Medtech laws?
Penalties may include administrative fines, suspension of registration, or product withdrawal. Early legal compliance is far more cost-effective than post-market penalties.
Can a foreign Medtech company operate directly in Turkey?
Yes, but you’ll need an Authorized Representative or local importer to interact with TITCK and manage your products on the ground.
What documents are required for CE Marking compliance?
You must maintain a Technical File, Risk Assessment, Clinical Evaluation Report, and Declaration of Conformity proving your device meets EU MDR standards.
How can Kurucuk & Associates assist during TITCK inspections?
We conduct mock audits, prepare documentation, and represent you during TITCK inspections — ensuring smooth communication and full compliance.
Get Expert Medtech Legal Support in Turkey
Kurucuk & Associates provides tailored legal counsel for Medtech, pharmaceutical, and life sciences companies operating in Turkey’s dynamic healthcare ecosystem.
Contact us today for strategic advice on compliance, TITCK registration, and market entry — and take your innovation from concept to clinic with confidence.