Medical Device Lifecycle Compliance


BradyKnows ensures our clients legally compliant to Chinese regulations and laws

Conception & Development

  • Regulatory intelligence
  • Design controls compliance

Pre-market

  • NMPA registration
  • Type testing
  • Clinical evaluation
  • Good Clinical Practice compliant clinical trials

Manufacture

  • Good Manufacturing Practice compliance
  • Packaging and labelling compliance
  • NMPA inspection and remediation

Sale

  • Good Sales Practice compliance
  • Advertising compliance
  • Periodic risk evaluation reporting (PRER)
  • Adverse event reporting

Use

  • Post-market surveillance
  • Quality assurance compliance
  • Intellectual property protection
  • Legal agent representation