CFDA Issued Six New Guidelines

Registration guideline

Scope of application

Issued date

Blood and blood component storage bag Registration Guideline.

全血及血液成分貯存袋注冊技術審查指導原則.pdf

This guideline can apply to blood bag that managed as medical devices as a reference for the non-clinical evaluation part registration dossiers preparation and product technical review.

01/10/2018

Disposable infusion pump (non-electric drive) Registration Guideline.

一次性使用輸注泵（非電驅動）注冊技術審查指導原則.pdf

This guideline can apply to disposable infusion pump (non-electric drive) as a reference for registration dossiers preparation and product technical review.

01/10/2018

Hemoconcentrator Registration Guideline.

血液濃縮器注冊技術審查指導原則.pdf

This guideline can apply to hemoconcentrator that made of hollow fiber and used during extracorporeal circulation. The blood is enriched by filtration. And the product is provided in a sterile, non-thermal condition. Only one time use.

01/10/2018

Proton Carbon Ion Therapy System Clinical Evaluation Technical Review Guideline.

質子碳離子治療系統臨床評價技術審查指導原則.pdf

This guideline can apply to proton or carbon ion therapy system. It belongs to medical high-energy ray equipment in the ‘Medical Device Classification Catalog(Year 2002 Version)’ and the MD code is 6832. Also other similar particle beam therapy system shall refer to the related content in this guideline.

1/8/2018

AnimalSource Medical Devices Registration Guideline

動物源性醫療器械注冊技術審查指導原則.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.

01/05/2018

Moveable Medical Devices Registration Guideline.

移動醫療器械注冊技術審查指導原則.pdf

This guideline can apply to moveable medical devices regisration application. It includes class II and class III medical device products.

12/29/2017