Registration guideline | Scope of application | Issued date |
Blood and blood component storage bag Registration Guideline. | 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. | 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. | 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. | 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 | 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. | This guideline can apply to moveable medical devices regisration application. It includes class II and class III medical device products. | 12/29/2017 |
CFDA Issued Six New Guidelines
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