Regulatory Framework for In Vitro Diagnostic Devices in India: Current Landscape, Challenges, and Future Perspectives

In vitro diagnostic (IVD) devices are essential for disease detection and clinical decision-making. India's IVD market has grown rapidly, but regulatory oversight has lagged. Although the Indian Medical Device Rules introduced a risk-based framework in 2017, persistent gaps in enforcement, quality standards, and post-market surveillance undermine diagnostic reliability.

This review examines India's IVD regulatory framework, focusing on device classification, approval pathways, quality management requirements, and post-market mechanisms. Particular attention is given to challenges such as enforcement issues, inconsistent compliance among small and medium enterprises, adoption barriers for national/international standards, weak post-market surveillance systems, and the absence of transparent public databases. Comparative analysis highlights India's shortfalls relative to the European and US systems, especially in mandatory clinical evidence, structured post-market surveillance, and stakeholder engagement.

Despite progress, India's IVD ecosystem remains constrained by fragmented oversight and weak harmonization with global standards. Strengthening regulatory capacity, mandating evidence-based evaluation, and fostering digital health readiness are critical to ensure patient safety and global competitiveness.