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 |
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
read moreThinking of selling your medical device in China? If so, you need to register your device with China's regulatory authority, the China Food and Dru
read more