MATERIOVIGILANCE AND MEDICAL DEVICE SAFETY MONITORING IN INDIA
Akash Kumar, Hiba Parveen, Yusra Ahmad, Dr. Lokesh Tyagi, Rimmi Rawat
Faculty of Pharmacy, Veer Madho Singh Bhandari Uttarakhand Technical University
Dehradun, India
Abstract: The systematic efforts to prevent and mitigate the dangers posed by medical devices are one of the principal functions of materiovigilance. MvPI’s inception under the Pharmacovigilance Programme in India was a significant milestone in enhancing the management of medical devices and regulatory intervention for the devices. The paper explores the roles of some members of the multidisciplinary healthcare team (physicians, nurses, biomedical engineers, pharmacists, & technical staff) and the potential device-related risk. The paper also explores the influence of maternal vigilance on the regulatory cycle (recalls & alerts, redesign & modification, & control) on the Medical Device Rules (MDR 2017). The paper also explores the current PMS in India and the positive indicators such as the rise in reporting centres, the growing number of reports submitted digitally, and the use of real-world data. India has made progress on Reporting Centre closure, Reporting Centre underuse, Reporting Centre untraceability, Reporting Centre manufacturer unaccountability, and Reporting Centre poor hospital culture weak Reporting Centre. India’s progress has been compared to that of other countries in order to highlight India’s progress. This comparison shows that India has made progress in reporting. India has made progress on reporting. This paper is focussed on reporting in order to enhance device safety and surveillance in India.
Keywords: Materiovigilance, Medical Devices, MvPI, Adverse Device Event (ADE), Post-Market Surveillance, Patient Safety, India.
VOLUME 10 ISSUE 04 2026: 143 – 158