Regulating the Future of Surgery: A Comparative Global Review of Approval Pathways, Safety Standards, and Compliance for Robotic Surgical Systems: A Comprehensive Global Policy, Regulatory Framework, and Risk Assessment Review
Abstract: Robotic Surgical Systems (RSS) have fundamentally transformed modern clinical therapeutics by enabling unprecedented precision, minimally invasive dexterity, and enhanced 3D visualization. However, the convergence of complex mechatronics, autonomous software algorithms, artificial intelligence (AI), and telesurgery presents unprecedented regulatory, ethical, and clinical risk profiles. This comprehensive review provides a rigorous comparative analysis of global approval pathways across four major jurisdictions: the United States (FDA), the European Union (EU MDR), Japan (PMDA), and India (CDSCO). We examine pre-market medical device classification, substantial equivalence standards, clinical evaluation requirements, cyber-security paradigms, post-market surveillance (PMS), and surgeon credentialing compliance. Furthermore, this paper critically addresses emerging regulatory hurdles surrounding generative AI integration, autonomous robotic navigation, liabilities in telesurgical latency, and data privacy frameworks. Recommendations are offered for establishing globally harmonized regulatory standards and adaptive oversight protocols to safe-guard patient safety while fostering technological innovation.
Keywords: Robotic Surgical Systems, Medical Device Regulation, Artificial Intelligence in Surgery, Patient Safety, Global Regulatory Standards
How to Cite?: Surender, Ashutosh Upadhyay, Shivali Rahi, "Regulating the Future of Surgery: A Comparative Global Review of Approval Pathways, Safety Standards, and Compliance for Robotic Surgical Systems: A Comprehensive Global Policy, Regulatory Framework, and Risk Assessment Review", Volume 15 Issue 10, October 2026, International Journal of Science and Research (IJSR), Pages: 1759-1763, https://www.ijsr.net/getabstract.php?paperid=SR261022143449, DOI: https://dx.doi.org/10.21275/SR261022143449