Shown below are some important regulatory documents impacting medical device companies. Unfortunately, the NMPA only makes these available in Chinese.
Major Regulations
| Document | Language | Number | Published |
|---|---|---|---|
| CFDA Medical Device Regulations | en | 650 | 2014 |
| Document | Language | Number | Published |
|---|---|---|---|
| CFDA Guidance on IFU, Labels and Packaging Logos of Medical Devices | en | 11 | 2014 |
| CFDA Guidance on IVD Registration (Chinese) | 5 | 2014 | |
| CFDA Guidance on Medical Device Labeling (Chinese) | 6 | 2014 | |
| CFDA Guidance on Medical Device Registration | en | 4 | 2014 |
| Guideline for Technical Review of Medical Device Software Registration (Chinese) | 2015 No. 50 | 10/2015 | |
| Technical Guidance on Clinical Evaluation of Medical Devices | en | Annex 14 | 05/2015 |
| Document | Language | Number | Published |
|---|---|---|---|
| Class I Filing Guide | en | 26 | 2014 |
| Medical device registration dossier requirements and approval documents format announcement | en | 43 | 2014 |