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

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 Materiovigilance Programme of India (MvPI) as of October 9, 2026? - How do the new guidelines affect manufacturers of AI-enabled devices and Software as a Medical Device (SaMD)? - Why are cybersecurity risks now a formal part of India's post-market surveillance? - What does the expansion of adverse event reporting to Primary Health Centers mean for vigilance teams? - How should manufacturers update their post-market surveillance plans to comply with the new MvPI? - What practical steps can regulatory teams take to prepare for these changes? - Who is primarily responsible for reporting these new types of adverse events to the CDSCO? Sources: - https://www.livemint.com/industry/manufacturing/india-overhauls-medical-device-safety-rules-expands-digital-surveillance-111970643130175.html How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping them navigate complex markets like India. Our experts can assist with developing and updating your post-market surveillance and vigilance systems to meet the new MvPI requirements. We act as your local representative, manage submissions to authorities like the CDSCO, and provide continuous regulatory monitoring to ensure you stay compliant. By combining local expertise with advanced AI, we streamline the process of maintaining market access. Contact us at [email protected] or visit https://pureglobal.com. Explore our free AI regulatory tools and global device database at https://pureglobal.ai.