Regulatory Approaches to Medical Devices: A Comparison between the United States, European Union, and India

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This survey compares FDA's centralized model and EU's decentralized system for medical devices, highlighting key regulatory differences.

Key differences exist between regulatory frameworks for medical devices in the US, EU, and India, affecting their market access.
The FDA employs a risk-based approach to medical device approval, contrasting with the EU's decentralized model emphasizing clinical data.
India's regulatory landscape is guided by Medical Device Rules (2017), aiming for alignment with international standards, yet facing implementation challenges.
The study identifies areas for improving regulatory consistency, efficiency, and accessibility of medical technologies worldwide.

Kothwala et al. (2025) studied this question.

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