Lessons from global materiovigilance systems: What India can learn?

Medical devices are indispensable in modern healthcare, playing a crucial role in diagnosing, treating, and managing various medical conditions. While these devices offer significant benefits, they also pose potential risks due to defects, malfunctions, or adverse events, which can lead to serious patient harm. To mitigate these risks, materiovigilance - the systematic monitoring, detection, assessment, and prevention of adverse events related to medical devices - is essential for ensuring their safety, efficacy, and reliability. Many developed nations have established robust materiovigilance frameworks, incorporating stringent regulatory oversight, mandatory reporting mechanisms, and active stakeholder involvement. Countries such as the United States, the United Kingdom, and those within the European Union have implemented comprehensive postmarket surveillance programs that emphasize real-time adverse event reporting, manufacturer accountability, and transparent data sharing. Regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency enforce compliance through strict regulations, periodic safety evaluations, and corrective actions to address identified risks. These systems encourage proactive surveillance, industry responsibility, and public access to safety information, fostering trust in medical devices. In contrast, India's materiovigilance system is still evolving. The Materiovigilance Programme of India, launched in 2015, is a crucial initiative aimed at improving medical device safety. However, challenges remain, such as limited mandatory reporting, low awareness among healthcare professionals, underreporting of adverse events, and inconsistent regulatory enforcement. By analyzing global best practices, India can strengthen its materiovigilance framework through enhanced reporting infrastructure, greater stakeholder engagement, and stricter regulatory policies.