CFDA Issued Two Clinical Evaluation of Technical Review Guidelines

December 22 2017, China Food and Drug Administration (CFDA)  issued two clinical evaluation of technical review guidelines including therapeutic respirator.

Registration guideline

Scope of application

Therapeutic respirator clinical evaluation of technical review guidelines.

治疗呼吸机临床评价技术审查指导原则.pdf

This guideline can apply to therapeutic respirator that is managed as class III medical devices. The device is used for life supporting or maintenance. Therapeutic respirator is an automatic device designed to increase or supply patient ventilation. Therapeutic respirator can be apply to adult, children, infant or newborn.  

Endometrial ablation device (Heat conduction, radiofrequency ablation) clinical evaluation of technical review guidelines.

子宫内膜去除(热传导、射频消融)设备临床评价技术审查指导原则.pdf

This guideline can apply to endometrial ablation device that make use of heat conduction and radio frequency ablation to remove endometrium. This kind of devices can apply to endometrial ablation because of women pre-menopausal, non-fertility requirement or menstrual excess caused by a benign illness(Excessive uterine bleeding). It is managed as class III medical devices. 

* If you have any comments or questions, please contact us at md@cirs-group.com. 

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