CFDA  Issued Ten Registration Guidelines

December 12 2017, China Food and Drug Administration (CFDA)  issued ten registration guideline including ultraviolet treatment equipment.

Registration guideline

Scope of application

Ultraviolet treatment equipment registration guideline.

CN: 紫外治疗设备注册技术审查指导原则.pdf

This guideline can apply to ultraviolet treatment equipment that take advantage of the physical properties of ultraviolet. The device for irradiating the human body(Wavelength Range 200nm-400nm). It is managed as class II medical devices.

Biomicroscope registration guideline.

CN: 生物显微镜注册技术审查指导原则.pdf

This guideline can apply to the class II medical devices biomicroscope that observe under the visible light and mechanical tube length is 160 mm. It can also apply to various biomicroscope that use photography and camera technology for image observation and processing.  

Slit-lamp microscope registration guideline.

CN: 裂隙灯显微镜注册技术审查指导原则.pdf

This guideline can apply to slit-lamp microscope in the ophthalmic optics. And it is managed as class II medical devices.


Infusion pumps registration guideline.

CN: 输液泵注册技术审查指导原则.pdf

This guideline can apply to infusion pumps in infusion assist device.

Central monitoring software registration guideline.

CN: 中央监护软件注册技术审查指导原则.pdf

This guideline can apply to class II central monitoring software. It is the independent software that collect data from the monitoring devices, ecntralized real-time display and give alert.  

Small-size sterilizer registration guideline.

CN: 小型蒸汽灭菌器注册技术审查指导原则.pdf

This guideline can apply to the class II autocontrol small-size sterilizer that confirmed to the definition in the standard YY/T 0646—2015 automatic control type small steam sterilizer. 

Dynamic ECG monitoring system registration guideline.

CN: 动态心电图系统注册技术审查指导原则.pdf

This guideline can apply to the dynamic ECG monitoring system that comfirmed to the definition of dynamic ECG monitoring system in the standard YY 0885—2013. The dynamic ECG monitoring system is used for continuous recording and analysis ECG. It is for the clinical diagnosis and managed as class II.

Intravascular balloon expansion catheter with balloon filling device registration guideline.

CN: 血管内球囊扩张导管用球囊充压装置注册技术审查指导原则.pdf

This guideline can apply to the intravascular balloon expansion catheter with balloon filling device. It is used in the interventional operation for the inflating and pressure relief of the balloon expansion catheter to realize the purpose of interventional therapy of expanding blood vessels and etc.

Refractometer registration guideline.

CN: 验光仪注册技术审查指导原则.pdf

This guideline can apply to the refractometer using objective measurement principle, with a continuous or digital readout used to determine the refractive state of the human eye. It belongs to the optometric device in the ophthalmic instruments. It is a class II medical devices.

Electro-stomach irrigator registration guideline(2017 revised version).

CN: 电动洗胃机注册技术审查指导原则(2017年修订版).pdf

This guideline can apply to class II Electro-stomach irrigator. The electric washing machine is divided into water pump type and pump type. The classification of control mode is divided into manual control and self-control. The product should be accompanied by a random wash tube.

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