NMPA Registration Chapters
Available Plans
Pro / Max / CRO
Overview
Generates registration submission materials following NMPA eRPS (Electronic Registration and Petition System) chapter structure.
eRPS Chapters
- Basic Product Information
- Summary Materials
- Non-clinical Research Materials
- Clinical Evaluation Materials
- Product Instructions and Labels
- Quality Management System Documents
- Other Materials
Supported Types
| Type | Description |
|---|---|
| Imported | Foreign manufacturer China registration |
| Domestic | Domestic manufacturer registration/filing |
Clinical Evaluation Exemption
For devices meeting exemption criteria, a simplified workflow generates exemption documentation (available on all plans).