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Post-market clinical follow-up (PMCF) trials are essential for maintaining the safety and performance of medical devices after market approval. Türkiye has become a strategic location for conducting these trials due to its regulatory environment and access to diverse patient populations. This article explains the framework, benefits, and operational aspects of PMCF trials in Türkiye. The Role of Post-Market Clinical Follow-Up Trials in Medical Device Regulation Post-market cl

Post-market clinical follow-ups (PMCF) are essential for maintaining medical device safety and performance after market entry. Türkiye's evolving regulatory landscape demands rigorous PMCF to ensure compliance and patient safety. This article explores key aspects of PMCF trials in Türkiye. Regulatory Framework for Post-Market Clinical Follow-Ups in Türkiye Türkiye aligns its medical device regulations with the EU Medical Device Regulation (MDR). The Turkish Medicines and Medi

Medical device clinical trials in Turkey offer a strategic opportunity for companies aiming to enter or expand in the regional market. The country’s regulatory framework, patient diversity, and cost-effective infrastructure make it an attractive destination for clinical research. This guide outlines the medical device trial process, regulatory requirements, and practical steps to conduct successful trials in Turkey. Overview of the Medical Device Trial Process in Turkey The m