Service items

SFDA Regulations for Clinical Trial

Medical device

- Provisions for Clinical trials of Medical Device(SFDA order No.5)
- General requirements on Clinical Trials of Cardiac Valve Prostheses(consultative draft)
- General requirements on Clinical Trials of Artificial Joints(consultative draft)
- The Application and Reaserch Progress of Hemodialyzer Membrane
- Several Problems that Shall be Noted on Clinical Trials After Drug-eluting Stent Goes to Market
- ARC Definition of Research Focus on Drug-eluting Stent

 

In vitro diagnostic reagents


- Guidance for Research Technology on In-virto Clinical Diagnostic Reagent.
- Basis Elements of Clinical Research on In Vitro Diagnostic Regents.

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