CFDA Issued Four Registration Guidelines

December 22 2017, China Food and Drug Administration (CFDA) issued four new registration guideline.

Registration guideline

Scope of application

Automatic blood type analyzer Registration guideline.

全自动血型分析仪注册技术审查指导原则.pdf

This guideline can apply to automatic blood type analyzer that conduct Blood group identification, antibody screening, cross-matching and etc. for the human blood type through test tube method, microporous plate method or column agglutination method.

ABO、RhD blood type antigen detection card(Column agglutination method) Registration guideline

ABO、RhD血型抗原检测卡(柱凝集法)注册技术审查指导原则.pdf

This guideline can apply to ABO、RhD blood type antigen detection card(Column agglutination method) and column agglutination method blood type detection card including ABO、RhD blood type antigen detection usage.

Human Epidermal Growth Factor receptor 2 gene amplification test kit (fluorescence in situ hybridization) Registration guideline.

人表皮生长因子受体2基因扩增检测试剂盒(荧光原位杂交法)注册技术审查指导原则.pdf

This guideline can apply to the fluorescence in situ hybridization method used to detect HER2 gene amplification in the biopsy samples and biopsy samples. It includes HER2 gene average copy number (single signal),HER2 gene average copy number and the ratio of the average copy number of chromosome 17 (CEP17) in chromosome 17 of the gene (double signal).

Hepatitis c viral nucleic acid genotyping test kit Registration guideline

丙型肝炎病毒核酸基因分型检测试剂盒注册技术审查指导原则.pdf

This guideline can apply to HCV nucleic acid genotyping test kit that based on PCR(polymerase chain reaction)method. 

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