A decade of review in global regulation and research of artificial intelligence medical devices (2015-2025).

Abstract

Artificial intelligence (AI) and medical devices are increasingly integrated, reshaping global diagnostic paradigms. However, the adaptive learning and opaque nature of AI technologies pose significant challenges to traditional regulatory frameworks. In response, regulatory bodies worldwide, including the U.S., EU, China, Japan, and South Korea, have initiated various policies to address the unique risks posed by AI medical devices (AIMD). These efforts aim to balance innovation with patient saf