NMPA

The National Medical Products Administration (NMPA) is China's regulatory authority responsible for overseeing drugs, medical devices, and cosmetics. It was reorganized from the former China Food and Drug Administration (CFDA) in 2018.

NMPA responsibilities:
- Medical device registration and surveillance
- Drug approval and monitoring
- Cosmetics regulation
- Policy development and enforcement
- International cooperation

Medical device classification in China:
- Class I - Low risk (municipal level registration)
- Class II - Medium risk (provincial level registration)
- Class III - High risk (NMPA national registration)

Registration requirements:
- Foreign manufacturers must appoint a Chinese agent
- Product testing at NMPA-recognized labs
- Clinical trials often required (at Chinese sites)
- Chinese language labeling
- GMP inspection may be required

Key registration pathways:
1. Standard Registration - Full clinical trials in China
2. Green Channel - Expedited for innovative/breakthrough devices
3. Priority Review - For devices with clinical urgency

Unique China requirements:
- In-country clinical data often required
- Registration holder must be Chinese entity
- Technical requirements may differ from FDA/EU
- Post-market surveillance (adverse event reporting)

Timeline: 12-24+ months depending on device class and clinical requirements.

Recent changes:
- Alignment with IMDRF standards
- Acceptance of some foreign clinical data
- Simplified pathways for certain devices
- Medical Device Regulation updates (2021)