Firstly, you can check the classification and its regulatory obligations under CFDA regulations by using CIRS free China Medical Device Regulatory Database (CMDRD).If the classification of you product can’t be determined by searching the existing classification catalogue or using classification criteria. We will help you submit an application to determine the classification to National Institutes for Food and Drug Control (NIFDC) of CFDA to further determine the classification and regulatory obligations.
If you wish to avail of this offer, please fill in this information form and send it to Ms. Elaine Lyu Elaine@cirs-group.com or md@cirs-group.com for free
More information on medical device classification
- What Is the Classification of Medical Device?
- How to Classify Your Medical Devices?
- Some devices are no longer managed as class I medical devices in China.