NMPA Registration Review Guidance Principles
NMPA issues 审查指导原则 for specific device types, published by CMDE (Center for Medical Device Evaluation).
Software & Digital Health
| Guidance | Year |
|---|---|
| 医疗器械软件注册审查指导原则 (2022) | 2022 |
| 人工智能医疗器械注册审查指导原则 | 2022 |
| 医疗器械网络安全注册审查指导原则 (2022) | 2022 |
| 移动医疗器械注册技术审查指导原则 | 2019 |
Clinical Evaluation
| Guidance | Year |
|---|---|
| 医疗器械临床评价技术指导原则 | 2021 |
| 医疗器械临床试验设计指导原则 | 2018 |
Biocompatibility
| Guidance | Year |
|---|---|
| 医疗器械生物学评价和审查指南 | 2021 |