The three pathways
Equivalence comparison, China trial (6–12+ months), or overseas-data acceptance — choosing the right one before you file.
Free field guide · PDF
China NMPA: Clinical Evaluation2026 Field Guide
The three pathways, the ethnic-difference analysis, and the safety rules — with the NMPA practice you need.
- Pathways
- 3
- China trial
- 6–12+ mo
- CMDE review
- 60–120 d
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The review reality
60–120 working-day CMDE review, the one-year Supplement Request clock, and the top deficiency triggers to avoid.
The safety rules
24-hour SAE reporting in China, 30-day overseas-AE reporting, and the China-specific testing you can't skip.
Sources & scope
- linkedin.com (Aiko Fong), The Complete Guide to Importing Medical Devices into China.
- bradyknowsmedical.com, NMPA Challenges & Pitfalls & Analysis.
- meddeviceonline.com, A Road Map To China's Medical Device Registration Process.
This guide is market-access intelligence, not regulatory or legal advice. NMPA clinical requirements, CMDE practice, and exemption catalogues change — professional review is required before business use.
Market Access Strategy Session
China on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your NMPA route — clinical pathway selection, ethnic-difference analysis, and dossier strategy.
Professional review is required before business use.
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