IPC orders device marketers to report adverse events
Change
The Indian Pharmacopoeia Commission ordered marketing rights holders to promptly report all medical-device adverse events to the Materiovigilance Programme of India (MvPI).
Why it matters
Marketing rights holders must submit both serious and non‑serious, and both known and unexpected, device adverse events to the MvPI platform. Reports are required to be made promptly. The directive notes the existence of simplified reporting mechanisms but identifies persistent underreporting by domestic manufacturers. The MvPI is the national system for monitoring, recording, and analysing root causes of device-related adverse events.
Implications
- • Update adverse-event reporting procedures to ensure prompt submission to MvPI.
- • Capture and categorise event severity and whether events are known or unexpected in reporting workflows.
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