Navigating the Evolving Regulatory Landscape
The medical device industry in Türkiye is governed by stringent regulations that are increasingly harmonized with European Union standards, including the MDR and IVDR frameworks. For manufacturers and importers, maintaining compliance with the Turkish Medicines and Medical Devices Agency (TITCK) is not just a legal requirement but a critical business necessity. We guide our clients through the complexities of the Product Tracking System (ÜTS), ensuring that every device meets the necessary safety and quality benchmarks before reaching the market.
Risk Management & Commercial Strategy
Beyond initial market entry, the medical device sector demands ongoing legal vigilance regarding product liability, clinical trials, and data privacy. Our firm provides strategic advice on structuring robust distribution and supply chain agreements that protect intellectual property while ensuring commercial agility. We help clients mitigate risks associated with post-market surveillance and advertising restrictions, allowing medical technology innovators to focus on improving patient outcomes while we handle the regulatory burden.
Our Services in Medical Devices Law
Regulatory Compliance & ÜTS Registration
Assisting with the registration and notification processes in the Turkish Product Tracking System (ÜTS) and ensuring adherence to MDR/IVDR.
Licensing & Market Access
Managing the legal procedures for obtaining establishment licenses, product certifications, and navigating reimbursement pathways.
Distribution & Supply Chain Agreements
Drafting and negotiating cross-border distribution, agency, and manufacturing agreements tailored to the medical device sector.
Product Liability & Safety
Providing legal defense and risk advisory on product defects, recalls, and adverse event reporting requirements.
Clinical Trials & Research
Structuring legal frameworks for clinical investigations, ensuring patient consent compliance, and managing ethics committee applications.
Public Procurement & Tenders
Advising on legal requirements for participating in public health tenders and managing disputes related to state procurement.
Why Choose
Karacabey
Practical, commercially aware legal advice tailored to your operations.
Schedule a ConsultationDeep Regulatory Knowledge
We stay ahead of the curve on TITCK regulations and EU directives, ensuring your products remain compliant in a shifting legislative environment.
Practical Business Solutions
Our advice is not just theoretical; we focus on removing legal bottlenecks to speed up your time-to-market and operational efficiency.
Proactive Compliance Monitoring
We act as a long-term partner, monitoring changes in advertising bans and data protection laws to prevent legal issues before they arise.
Clients We Serve
We work with a wide range of clients in the Medical Devices industry.
Need Legal Support?
Looking for a legal partner who understands your sector? Karacabey offers precise, strategic counsel for companies operating in regulated environments.
Schedule a Consultation