Classification, Clinical Evaluation, and Post-Market Surveillance of Robotic Surgical Devices: A Comparative Regulatory Review of Global Frameworks: A Comprehensive Comparative Analysis of US FDA, EU MDR, Japan PMDA, China NMPA, and India CDSCO Regulatory Pathways for Surgical Robotics
Abstract: Robotic Surgical Devices (RSDs) represent a transformative paradigm in modern clinical medicine, combining multi-axis mechanical articulation, advanced computer vision, haptics, and artificial intelligence (AI) to enable minimally invasive procedures across urology, gynecology, orthopedics, and neurosurgery. However, the rapidly advancing technological autonomy, software complexity, and complex mechanical architectures of modern RSDs present unprecedented challenges to global medical device regulatory authorities. This review paper provides a rigorous, exhaustive comparative analysis of the regulatory frameworks governing surgical robotics across five major jurisdictions: the United States (US FDA), the European Union (EU MDR 2017/745), Japan (PMDA/MHLW), China (NMPA), and India (CDSCO). We dissect the risk-based classification schemes, pre-market clinical evaluation requirements, software and AI integration guidelines (Software as a Medical Device - SaMD / Machine Learning-enabled Medical Devices - MLMD), cybersecurity frameworks, and post-market surveillance (PMS) and vigilance mandates across these regions. Furthermore, the paper analyzes the regulatory challenges posed by next-generation autonomous surgical platforms, tele-robotic surgical networks, and remote continuous updates. By identifying systemic harmonization bottlenecks under the International Medical Device Regulators Forum (IMDRF) and synthesizing emerging post-market signals, this paper offers strategic regulatory recommendations for medical device developers, clinical investigators, and regulatory professionals navigating the global commercialization of robotic surgical technologies.
Keywords: Robotic Surgical Devices (RSD), Medical Device Regulation, US FDA 510(k) / PMA, EU MDR 2017/745, Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS), Artificial Intelligence in Surgery, Software as a Medical Device (SaMD), Global Regulatory Harmonization
How to Cite?: Surender, Ashutosh Upadhyay, Shivali Rahi, "Classification, Clinical Evaluation, and Post-Market Surveillance of Robotic Surgical Devices: A Comparative Regulatory Review of Global Frameworks: A Comprehensive Comparative Analysis of US FDA, EU MDR, Japan PMDA, China NMPA, and India CDSCO Regulatory Pathways for Surgical Robotics", Volume 15 Issue 10, October 2026, International Journal of Science and Research (IJSR), Pages: 1764-1770, https://www.ijsr.net/getabstract.php?paperid=SR261022164344, DOI: https://dx.doi.org/10.21275/SR261022164344