Shown below are some important regulatory documents impacting medical device companies. Unfortunately, the NMPA only makes these available in Chinese.
| 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 |
The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Dru
read moreTo see their products to the Chinese market, medical device and IVD manufacturers will need to obtain National Medical Products Administration (NMP
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