New Circular Mandates Robust Adverse Event Reporting System for Medical Device License Holders
An Overview:
New Delhi, May 15, 2024 – The Ministry of Health & Family Welfare, through the Central Drugs Standard Control Organization (CDSCO), has issued a new circular on May 15, 2024, mandating all medical device license holders to implement robust systems for identifying, documenting, and reporting adverse events associated with medical devices.
Enhanced Regulation and Post-Market Surveillance
All medical devices, including in-vitro diagnostics, now require licenses under the Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017. The circular highlights the importance of Post-Market Surveillance (PMS) to ensure device safety and performance, urging timely reporting of adverse events to identify and mitigate risks.
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Materiovigilance Programme of India (MvPI)
The Materiovigilance Programme of India (MvPI), led by the Indian Pharmacopoeia Commission (IPC), is central to this initiative, aiming to improve patient safety by monitoring and analyzing adverse events. The circular calls for active participation from the medical device industry to use the MvPI platform for reporting adverse events.
Resources and Training
Guidance documents are available on the IPC website, and training can be requested via mvpi-ipc@gov.in. Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), urges all license holders to comply with these new requirements to enhance medical device safety in India. For more information, visit the IPC website.
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Ensure Compliance with New Medical Device Reporting Mandates
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