The journal of applied laboratory medicineIndiaHumansDiagnostic EquipmentProduct SurveillancePostmarketing
Regulatory Framework for In Vitro Diagnostic Devices in India: Current Landscape, Challenges, and Future Perspectives.
Mahima Ramesh, Harsh Sah, Amrutha C
Published: 202610.1093/jalm/jfaf164
Abstract
BACKGROUND: 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-base…
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