How to identify the class of medical device will be paid highly attention by the registrant. The main method to confirm the classification of medical device to classification catalogue and classification principle of medical device, application of medical device classification definition.
CIRS professional team provides following classification determination service to be the foundation for medical device recording/registration procedure.
|Service Content||Advantage of CIRS||Service Details|
|Determining the Classification||Identify the class of medical device according to CFDA published classification catalogue and classification principle of medical device.||
Period: 8 business days
|Application of classification definition||This type of service is applicable to products that are unable to determine the type through the existing regulations, and need to submit classification definition applications to the CFDA||
Data compilation: 30 working days
Audit in the Provincial FDA: 1-2 months
Audit in CFDA: 6-12 months
Charge: according to the product
SERVICE FLOW CHART(Click on the picture to zoom in)
CIRS medical device service team mainly consists of experienced registration and clinical experts with master’s degree and PhD in medical background. Medical devices service team is divided into three professional groups: regulatory affairs service group, clinical trials service group and customs service group. Also we have good network with other professional institutions. And our goal is to provide the most professional, efficient, long- term and comprehensive service for our clients.
* If you have any comments or questions, please contact us at firstname.lastname@example.org.