Medical Device Classification Determination - Regulatory News - Medical Devices

In the medical device recording or registration procedure, accurately identify the class of the device will be the first and essential step that has significant influence on the registration procedure, cost and period.

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.

OUR SERVICE
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.	Rich Industry experience Quickly and clearly identify the categories In combination with customer requirements, prior to the preparation of reporting data Professional declaration materials for subsequent registration to lay a good foundation Address language barriers	Period: 8 business days Charge: free
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)

OUR TEAM
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 md@cirs-group.com.

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