CFDA Issued Two Clinical Evaluation of Technical Review Guidelines

Registration guideline

Scope of application

Therapeutic respirator clinical evaluation of technical review guidelines.

治療呼吸機臨床評價技術審查指導原則.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.

子宮內膜去除（熱傳導、射頻消融）設備臨床評價技術審查指導原則.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.