Biosensors in Wearable Medical Devices: Regulatory Framework and Compliance across US, EU, and Indian Markets.

Abstract

Biosensors play a crucial role in the diagnosis and monitoring of diseases as therapeutic applications that come with ease through incorporation and collaboration with wearable medical devices. Various regulatory markets are implementing development and management strategies for this emerging medical device field. This paper provides regulatory navigation of biosensors in wearable diagnostic devices across the US, EU, and Indian markets. The regulatory structure of all three countries differs from their origination and management which is discussed in this article along with the regulatory requirements applicable to such devices. The study also focuses on areas such as Good Manufacturing Practices (GMP), risk-based device classification, validation, and post-market surveillance. Key highlights include understanding regulatory authorities, guidelines, rules, regulations, and standards; comparison of regulatory perspectives between the three markets; application of biosensors in medical devices; prospects and market size. The study identifies approval pathways, regulatory challenges, and harmonization efforts across the globe. The paper explores recent advancements in biosensors for health interventions, such as personalized medicine, collaboration with the IoT, biomedical applications, and their accessibility.