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 characterized by its market adaptability and flexibility. Meanwhile, China adopts a comprehensive and process-oriented approach towards the regulation of AI in medical devices. A comparative analysis of regulatory mechanisms across the United States, the European Union, and China reveals that the articulation of coherent technical review standards, the critical points of AI regulation including the emphasis on data consistency evaluations, the integration of clinical trial data to an appropriate degree, and the implementation of forward-looking strategies for software modification control, etc.. Jurisdictions beyond these leading entities are advised to assimilate the regulatory insights from these frontrunners for a more balanced regulatory framework, tailor them to the unique exigencies of their respective locales, institute a definitive ethical framework, and astutely establish core evaluative benchmarks on algorithm interpretability, consistency, and clinical validity.