Materiovigilance Program Of India (MVPI): Current Need And Status In Country

ABSTRACT

Background:The term “medical device” includes a broad classification of production ranging from therapeutic medicinal devices withlocal uses tohighlyadvanced electronic medicalequipmentandindicativemedicaldevices. These devices vary widely in their production, type and are highly essential for patients’ care. Thus, their manufacturing, distribution, and sales must be managed to ensure their quality, safety, and efficacy. They play a major role in to detection, assessment and management and treatment of many different diseases. That being said, the quality of devices can very different and even the perfectly articulated products can fail in clinical practice. Post-market surveillance istherefore essential to ensure the quality and evaluate the safety and performance of medical devices. Despite the importance placed on surveillance of drug safety, the need for better monitoring of medical device-associated adverse events receives less attention. A well-structured vigilance system is the backbone of a robust regulatory framework to ensure the quality and promote the safe use of medical devices. The regulation of medical devices, however, is a complex and constantly evolving area that is often complicated by legal technicalities. Although the regulations may differ from one country to another.