Clinical Trial Agent

Legal basis

• 1
  Specification for quality management of medical devices clinical trials
• 2
  Sample Serious adverse event Report Form for clinical trials of medical devices/in vitro diagnostic reagents
• 3
  Catalogue of basic documents for clinical trials of medical devices/in vitro diagnostic reagents
• 4
  Sample clinical trial protocol for in vitro diagnostic reagents
• 5
  Sample clinical trial report of in vitro diagnostic reagents
• 6
  Sample clinical trial report for medical devices
• 7
  Sample clinical trial protocol for medical devices

Required documents:

Product technical requirements

Product description

Product registration inspection report

Clinical approval (if required)

Production enterprise certification documents

Product listing certificate (imported products)