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

Abstract

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