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China Medical Device Registration Fees
NMPA government fees for 2025
CNY 210,900
Low Risk Min
CNY 308,800
High Risk Max
NMPA
Authority
2025-12-16
Last Updated
China (NMPA) Fee Overview
China (NMPA) has some of the highest government fees globally. Class II registration costs CNY 210,900 (~$29,000) and Class III costs CNY 308,800 (~$43,000). Unlike other markets, China requires mandatory in-country testing for most devices, adding $5,000-$20,000+ to actual costs. Registration is valid for 5 years with renewal fees of CNY 40,800.
Complete Fee Breakdown
| Fee Item | Amount | Frequency |
|---|---|---|
Initial Registration - Class II | CNY 210,900 | Per registration |
Initial Registration - Class III | CNY 308,800 | Per registration |
Variation - Class II | CNY 42,000 | Per variation |
Variation - Class III | CNY 50,400 | Per variation |
Renewal - Class II/III | CNY 40,800 | Every 5 years |
Key Facts About NMPA Fees
- 1Class II registration: CNY 210,900 (~$29,000)
- 2Class III registration: CNY 308,800 (~$43,000)
- 3Renewal fee: CNY 40,800 every 5 years
- 4In-country testing: $5,000-$20,000 additional
- 5Mandatory local agent required
Important Notes
- •Class I: Filing only, minimal fees
- •Class II/III: Full registration required
- •Registration valid for 5 years
- •In-country testing may be required ($5,000-$20,000 USD)
Tips for China Registration
- 1Budget for mandatory in-country testing (Type Testing)
- 2Use a licensed Chinese agent for all submissions
- 3Start renewal process 6-12 months before expiry
Frequently Asked Questions
Related Resources
Government fees are subject to change. Last data update: 2025-12-16. Always verify current fees with NMPA.