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

View Full Paper

Ask AI

Bookmark

Authors

Discussion

This survey compares regulatory frameworks for medical devices in three regions, highlighting differences that affect market access.

Regulatory frameworks for medical devices differ significantly among the US, EU, and India, impacting how devices are approved and marketed.
The study highlights the U.S. FDA's centralized, risk-based approach versus the EU's decentralized model under the EU MDR 2017/745.
India's Medical Device Rules (2017) show progress, but challenges remain in implementation and infrastructure for consistency in regulations.
A comparative analysis reveals opportunities to enhance efficiency and accessibility in global medical technology regulations.

Kothwala et al. (2025) studied this question.

View Full Paper

Ask AI

Bookmark