COMPARATIVE STUDIES BETWEEN INDIAN REGULATORY REQUIREMENTS AND GLOBAL BENCHMARKS FOR SURGICAL ROBOTS

Mamta Choudhary, Shivali Rahi*, Ashutosh Upadhayay

Surgical robots have emerged as advanced medical technologies that enhance surgical precision and patient outcomes. Their increasing global adoption has prompted regulatory authorities to strengthen oversight to ensure safety and performance. Major jurisdictions such as India, USA, European Union, and Japan classify surgical robots as high-risk devices and require comprehensive evaluation. This work aims to conduct a comparative assessment of Indian regulatory requirements for surgical robots against the established frameworks of the United States, European Union, and Japan. A qualitative comparative analysis based on regulatory frameworks outlined in the provided documents. It systematically examined key regulatory domains across major jurisdictions. The parameters evaluated included risk classification, pre-market approval pathways, clinical evidence requirements, quality management systems, software/AI governance, and post-market surveillance mechanisms. India classifies surgical robots as Class C/D high-risk devices and increasingly aligns with International Medical Device Regulators Forum (IMDRF) and ISO 13485 principles. Compared to the USA and EU, India presents lack in regulatory benchmark. Global regulators maintain more stringent and structured approval pathways. While India’s regulatory framework for surgical robots is progressing toward global harmonization, significant gaps remain in clinical evidence standards, software oversight, and post-market monitoring. Addressing these gaps is essential for ensuring safe adoption and global competitiveness of robotic-surgical technologies in India.