India's Revised Materiovigilance (MvPI) Guidelines: Expanded Scope for Software, AI, and Cybersecurity

Medical Device Global Market Access · Oct 12, 2026 · 5m

India has significantly overhauled its medical device safety monitoring framework. Effective October 9, 2026, the revised Materiovigilance Programme of India (MvPI) guidelines now explicitly include software glitches, AI-enabled device performance, and cybersecurity risks as reportable adverse events. This episode breaks down the expanded scope, the new requirement for reporting from Primary Health Centers, and the practical implications for manufacturers' post-market surveillance and vigilance obligations in this key market. Key Questions: - What are the key changes in India's revised…