ADVERSE EVENT REPORTING FOR MEDICAL DEVICES: A COMPARISON OF PROCESSES IN INDIA AND THE USA

Dr. Arun Ghosh*

ABSTRACT

Medical devices are essential in modern healthcare, facilitating patient care through diagnosis, treatment, and monitoring. However, their widespread use is also associated with an increased incidence of adverse events. Regulatory frameworks like the FDA in the USA and the Materiovigilance Programme of India (MvPI) aim to improve the safety of medical devices through proper reporting of adverse events and regulation of their manufacture, import, and use. The FDA has a comprehensive post-market surveillance system compared to India’s MvPI. Launched in 2015, the MvPI is still evolving as an effective monitoring framework and focuses on adverse event reporting and analysis. The MvPI has established 451 Medical Device Adverse Event Monitoring Centres nationwide, and the government introduced the Medical Devices Rules in 2017 for better regulation. Both countries encourage the reporting of adverse events by healthcare professionals, manufacturers, and consumers to ensure timely interventions. However, the MAUDE (Manufacturer and User Facility Device Experience) database provided by the FDA makes data regarding medical device adverse events more accessible to the public and healthcare professionals.

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