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 |
China represents a vast market for medical devices, but its regulatory system can be difficult to navigate. A recent report published by China’s me
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
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