GENERAL

 

• Nuremberg Code  

• The Declaration of Helsinki 

• The Belmont Repot 

 

FDA

 

• FDA Federal Regulations on GCP and Clinical Trials 

• FDA Federal Regulation on Medical Devices  

 

ICH

 

• ICH Guideline on Good Clinical Practice (GCP) [E6] 

• ICH Efficacy Guidelines  

• ICH Safety Guidelines 

• ICH Quality Guidelines 

• ICH Good Manufacturing Practice Guideline (GMP) [Q7] 

• ICH Multidisciplinary Guidelines 

 

ISRAEL

 

• Israeli MoH Guideline on Human Clinical Trials (2014) 

• Israeli MoH Guideline on Adverse Events and New Safety Information Reporting 

 

MEDDEV

 

• MEDDEV Guidelines on Clinical Investigations of Medical Devices 

• MEDDEV Guidelines on Clinical Evaluation of Medical Devices 

• MEDDEV Guideline on Classification of Medical Devices 

• MEDDEV Guideline on Post Market Clinical Follow Up Studies 

• MEDDEV Guideline on the Medical Device Vigilance System