Regulatory Affairs & Reimbursement
REGULATORY AFFAIRS & REIMBURSEMENT
Registration Opens the Door.
Reimbursement Opens the Market.
Medical device market access requires more than regulatory approval. Understanding registration requirements, reimbursement pathways, and public procurement procedures is essential for building a sustainable commercial presence.
Gradyan supports international manufacturers in navigating Türkiye's medical device regulatory and reimbursement environment.
THREE DISTINCT PROCESSES
Understanding the Market Access Pathway
ÜTS Registration
Product documentation, regulatory compliance, and registration in Türkiye's Product Tracking System (ÜTS).
SGK / SUT
Assessment of applicable reimbursement provisions, product classification, and relevant application requirements.
DMO
Evaluation of applicable State Supply Office procurement requirements and product listing procedures.
HOW GRADYAN SUPPORTS YOU
Practical Regulatory Guidance
Documentation & Compliance Review
Reviewing relevant certificates, technical documentation, and local regulatory requirements.
ÜTS Registration Support
Guiding manufacturers and authorized local parties through registration preparation and coordination.
Reimbursement Strategy
Evaluating SUT provisions, reimbursement conditions, and potential application pathways for specific products.
DMO & Regulatory Updates
Supporting the assessment of DMO requirements and relevant regulatory changes.
GRADYAN GROUP
The Right Roadmap Saves Time and Resources.
Every medical device has different regulatory and reimbursement considerations. Gradyan helps manufacturers identify the appropriate pathway, understand potential barriers, and plan their market access activities more effectively.
Discuss Your Regulatory Requirements