CFDA Issued Four New Medical Device Registration Guidelines

September 21th 2017, China Food and Drug Administration (CFDA) issued four new registration guidelines (exposure draft).

Guideline	Applicable Scope
Hard Optical Endoscope (invasive type) Registration Technical Guideline CN: 硬性光学内窥镜（有创类）注册技术审查指导原则	Apply to: the class III Hard Optical Endoscope. It mainly enter the human body by invasive method instead of the human natural body orifice. Not apply to: soft endoscopes, electronic endoscope, none optical imaging system vision tube and sighting tube.
Ultrasonic Soft Tissue Cutting Hemostatic Knife Registration Technical Guideline CN: 超声软组织切割止血刀注册技术审查指导原则	Apply to: Ultrasonic Soft Tissue Cutting Hemostatic Knife products with soft tissue cutting or vessel sealing function. Not apply to: The cutting or closure function products for vessel 3mm and above
Ophthalmic Ultrasound Diagnostic Equipment Registration Technical Guideline CN: 眼科超声诊断设备注册技术审查指导原则	Apply to: Ophthalmic A- type and B-type Ultrasound Diagnostic Equipment, the general ultrasonic diagnostic equipment that apply to the eyes or eye diagnostic/cure devices with Ophthalmic A/B ultra-function. Not apply to: High frequency ophthalmic ultrasound diagnostic instrument or acoustic biological microscope
Human Epidermal Growth Factor Receptor（EGFR）Mutated Gene Detection Reagent Registration Technical Guideline CN: 人表皮生长因子受体（EGFR）突变基因检测试剂技术审查指导原则	Apply to: Human Epidermal Growth Factor Receptor（EGFR）Mutated Gene Detection Reagent based on nucleic acid polymerase chain reaction(PCR method). With EGFR mutations detecting target, in vitro qualitative detection cytology samples, in the human body, frozen tissue, sex of formaldehyde fixed paraffin embedding tissue and peripheral blood samples, other body fluids extraction of nucleic acid component of the target gene sequence.

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