Regulatory approaches towards AI Medical Devices: A comparative study of the United States, the European Union and China.

Abstract

The swift progression of AI within the realm of medical devices has precipitated an imperative for stringent regulatory oversight. The United States, the European Union, and China stand as vanguard entities in the regulatory landscape for AI-enhanced medical devices, each delineating unique regulatory frameworks. The European Union is renowned for its avant-garde approach to AI legislation, placing a significant onus on data security. Conversely, the regulatory paradigm in the United States is c