Nexiv Global Insights

Health Market Access — Explained.

Practical guidance on NMPA registration, FDA compliance, Blue-hat certification, and cross-border health market entry — from specialists who've been inside the regulatory system.

NMPA Registration · Medical Devices · China Market Entry

NMPA Medical Device Registration: Complete Guide for Foreign Manufacturers (2026)

Step-by-step guide to registering a medical device with China's NMPA — Class I, II, and III pathways, realistic timelines, government fees, Authorized Agent requirements, and the most common reasons dossiers fail. Written by former NMPA review specialists.

April 13, 2026 · 16 min read
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2026 Complete Guide
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NMPA
Class I–III
NMPA Regulation · BCI · Medical Devices

China's Brain-Computer Interface Medical Device Regulations: A Complete Guide for 2026

How China's NMPA classifies BCI devices — from Class II wearables to Class III invasive implants — with timelines, fast-track pathways, and what foreign manufacturers need to know.

April 10, 2026 · 14 min read
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