April 28, 2026 · KNOWLEDGE
CE MDR vs MDD: What Changed for Medical Robots
How Europe's shift from MDD to MDR changed CE marking for medical robots — clinical evidence, software rules, Notified Body scrutiny, and transition timelines.
›#Regulatory-Primer
5 articles
April 28, 2026 · KNOWLEDGE
FDA 510(k) vs PMA vs De Novo Pathways Compared
Plain-language comparison of FDA 510(k), PMA, and De Novo pathways for medical devices — which surgical robots use each route and why it matters.
›April 28, 2026 · KNOWLEDGE
How NMPA Class III Medical Device Approval Works in China
Practical primer on NMPA Class III medical device approval — classification, clinical trial, technical review, and what's different for surgical robots.
›April 28, 2026 · KNOWLEDGE
NMPA Innovative Medical Device Green Channel Explained
How China's NMPA Innovation Green Channel works — qualification criteria, priority review benefits, and how surgical robots have used this pathway.
›April 28, 2026 · KNOWLEDGE
Reading NMPA Registration Numbers: Decoding the Format
NMPA numbers encode approval year, device class, and category prefix. Learn to read 国械注准/国械注进 format using real examples from Chinese medical robots.
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