Ran Chen

The same orthopedic implant can be Class II in the United States and Class III across the European Union, China, Japan and Australia. This report compares pathways, realistic timelines, government fees, reliance limits and mandatory in-country-representative costs across seven major markets.

The same aesthetic device can face a different risk class, evidence burden and registration route in every major market. This research report compares fillers and energy-based platforms across the United States, European Union, China, Korea, Brazil and Japan — including realistic timelines, regulator fees, reliance routes and mandatory in-country-representative costs.

The continuous glucose monitor is the fastest-scaling category in diabetes technology, and in 2024 it broke out of diabetes entirely — onto pharmacy shelves as an over-the-counter wellness product. Yet the same sensor is Class II in the U.S. (now sold OTC), Class IIb in the EU, and Class III in China. This report maps how every major regulator classifies, approves, and reimburses CGM — and why a single FDA clearance or CE mark clears none of the three gates (approval, reimbursement, intellectual property) by itself — with registration costs, timelines, and reliance routes across 30+ markets.

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.