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 Research 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 

Drugs

• Good Clinical Practice for Drugs (SFDA order No.3)

In vitro diagnostic reagents

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