CFDA Issued Four New Medical Device Registration Guidelines - Regulatory News - Medical Devices

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: 硬性光學內窺鏡（有創類）注冊技術審查指導原則	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: 超聲軟組織切割止血刀注冊技術審查指導原則	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: 眼科超聲診斷設備注冊技術審查指導原則	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: 人表皮生長因子受體（EGFR）突變基因檢測試劑技術審查指導原則	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.

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

We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.