China NMPA Medical Device Regulations
Shown below are some important regulatory documents impacting medical device companies. Unfortunately, the NMPA only makes these available in Chinese.
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | CFDA Medical Device Regulations | 650 | 2014 | |
| Download | CFDA Medical Device Regulations | 650 | 2014 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | CFDA Guidance on IVD Registration (Chinese) | 5 | 2014 | |
| Download | CFDA Guidance on Medical Device Registration | 4 | 2014 | |
| Download | Guideline for Technical Review of Medical Device Software Registration (Chinese) | 2015 No. 50 | 10/2015 | |
| Download | CFDA Guidance on Medical Device Labeling (Chinese) | 6 | 2014 | |
| Download | CFDA Guidance on IFU, Labels and Packaging Logos of Medical Devices | 11 | 2014 | English |
| Download | CFDA Guidance on Medical Device Registration | 4 | 07/2014 | English |
| Download | Technical Guidance on Clinical Evaluation of Medical Devices | Annex 14 | 05/2015 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | Class I Filing Guide | 26 | 2014 | English |
| Download | Medical device registration dossier requirements and approval documents format announcement | 43 | 2014 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | CFDA Streamlines Registration of Innovative Devices (Chinese) | 98 | 2013 | |
| Download | CFDA Proposed Adverse Event Monitoring (Chinese) | 205 | 2013 | |
| Download | CFDA Classification of 17 Categories of Devices (Chinese) | 361 | 2012 | |
| Download | CFDA Reclassification of 73 Devices (Chinese) | 271 | 2012 |
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