India mandates reporting of medical device adverse events
Marketers must report all device adverse events to national system
Change
India required marketing rights holders to report all medical device adverse events to the Materiovigilance Programme.
Why it matters
The directive mandates reporting of all adverse events, including serious, non-serious, known, and unexpected cases, to the national monitoring system. It addresses underreporting and strengthens post-market surveillance requirements.
Implications
- — Medical device marketers must report all adverse events promptly — failures risk regulatory action
- — Compliance teams must establish reporting systems — gaps risk safety and enforcement exposure
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