Ran Chen

Artificial intelligence is the fastest-growing class of medical device in history — and the most regulation-divergent. The U.S. FDA now lists 1,524 AI-enabled devices; South Korea authorized 153 in a single year. Yet the same software is Class II in the U.S., Class IIa+ and 'high-risk' in the EU, and Class III in China — each with its own evidence, local-holder, and change-control rules. This report maps how every major regulator classifies, approves, and polices AI as a medical device, with registration costs, timelines, and reliance routes across 30+ markets, and the playbook for reaching them without rebuilding the dossier each time.