The MDRC pathway, by class
Class I filing in weeks, Class II/III registration in 12–24 months; ¥210,900–¥308,800 review fees; MDRC valid five years; home-country approval required.
Free field guide · PDF
China NMPA Medical Device Registration2026 Field Guide
What manufacturers need to know before entering the world's second-largest device market — the MDRC pathway, the mandatory China legal agent, and why FDA or CE approval alone doesn't get you in.
- MDRC validity
- 5 years
- Class III review fee
- ¥309k
- Class II/III timeline
- 12–24 mo
Sourced from NMPA guidance and 2026 registration practice.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — NMPA guidance and 2026 registration practice.
The China legal agent
No direct filing for foreign makers; the agent carries post-market duties — and draft reforms raise the bar to a licensed 'domestic person responsible'.
Testing, evidence, language
NMPA-accredited lab testing even with FDA/CE in hand, clinical evaluation or exemption, and everything in Chinese — classification first.
Sources & scope
- ElendiLabs, China NMPA medical device registration guide.
- Aiko Fong, the complete guide to importing medical devices into China — July 2026.
- China Britain Business Council, getting devices approved for sale in China.
- Artixio, medical device regulations in China (NMPA).
This guide is market-access intelligence, not legal or regulatory advice. NMPA requirements change — professional review is required before business use.
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