China
China is the second largest medical device market in the world, with growing demand for innovative and imported products.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the National Medical Products Administration (NMPA).
Device Classification:
- Class I: Low risk
- Class II: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation in Chinese. |
| Local Representative | Required for foreign manufacturers. |
| Local clinical trials | Often required for Class II and III devices. |
Challenges and Operational Advice
- Long timelines: The process can take over 24 months for Class III devices.
- Strict regulations: Adapting to Chinese requirements is essential.
Why Choose ISEMED
- China Expertise
Direct experience with NMPA procedures. - Complete Support
Assistance with certifications and clinical trials.
FAQ
- Is a local representative required? Yes.
- Documentation language? Chinese.
- License duration? 5 years.