India tightens adverse-event reporting for medical devices

Economic Times
Economic Times 1w India
The Indian Pharmacopoeia Commission ordered medical-device marketing rights holders to promptly report all adverse events—serious and non-serious, known and unexpected—via the Materiovigilance Programme of India (MvPI) platform.
India tightens adverse-event reporting for medical devices
Why it matters
The directive was issued by the Indian Pharmacopoeia Commission (IPC) in a letter signed by its secretary-cum-scientific director, V Kalaiselvan, citing concerns about underreporting of adverse events, including cases linked to domestically made equipment. Reporting is to be done on the government’s MvPI system, which the health ministry launched to monitor, record and analyze adverse events associated with medical devices. The article notes the instruction comes in the context of an India recall of a Johnson & Johnson hip replacement device after global reports of metal poisoning and high failure rates, and follows earlier guidance from India’s drug regulator for manufacturers to set up systems for timely adverse-event identification and reporting.
TOPICS

Law & Public Safety Regulatory Actions Health & Medicine Healthcare Systems

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