Abstract

REGULATORY APPROVAL OF IN VITRO DIAGNOSTIC MEDICAL DEVICES IN INDIA: CURRENT FRAMEWORK, REQUIREMENTS, CHALLENGES AND FUTURE PERSPECTIVES

M. Krishna Snigdha*, G. Ramakrishna, M. V. Nagabhushanam, M. Beena Devi, Enapagundla Brahmareddy, Katakam Hepsiba

Abstract

In vitro diagnostic (IVD) medical devices play a critical role in disease diagnosis, screening, prognosis, therapeutic monitoring, and public-health surveillance. In India, IVDs are regulated under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules (MDR), 2017, with regulatory oversight by the Central Drugs Standard Control Organisation (CDSCO). The MDR, 2017 established a risk-based regulatory framework in which IVDs are classified into Classes A, B, C, and D according to increasing individual and public-health risk. Regulatory requirements encompass device classification, manufacturing and import licensing, quality management systems, technical documentation, risk management, analytical and clinical performance evaluation, labelling, and post-market surveillance. Manufacturers are required to demonstrate compliance with applicable quality and performance requirements, while importers must additionally fulfil authorized representation and supporting documentation obligations. Post-market safety monitoring is supported through the Materiovigilance Programme of India. Although the Indian regulatory system has undergone substantial modernization, challenges persist in regulatory awareness, documentation quality, performance-evaluation infrastructure, approval timelines, adverse-event reporting, and regulation of emerging technologies. This review critically summarizes the regulatory pathway for IVD medical devices in India and highlights future priorities including international harmonization, regulatory digitalization, stronger clinical evidence, enhanced materiovigilance, and preparedness for artificial intelligence, molecular diagnostics, and other next-generation diagnostic technologies.

Keywords: In vitro diagnostic devices; CDSCO; Medical Devices Rules 2017; IVD regulation; clinical performance; quality management system; materiovigilance; India.