IPC issued updated hospital guidance (MvPI v1.3) for reporting medical-device adverse events
The Indian Pharmacopoeia Commission (IPC), with WHO India and other stakeholders, developed an updated guidance document for hospitals—"Guidance document for hospitals in India for safety monitoring and reporting of medical devices related incidents/adverse events" (Version 1.3)—under the Materiovigilance Programme of India (MvPI). The document asks hospitals nationwide to set up structured systems to monitor and promptly report suspected medical device adverse events, with specified timelines (eg, serious events within 15 days and certain non-serious events within 30 days).
More consistent, time-bound reporting and root-cause analysis of device incidents can help detect safety signals earlier and support corrective actions to improve patient and user safety.