Florence Compliance Guidelines for South Korea

Florence’s Compliance Team has reviewed regulations set forth by the Ministry of Food and Drug Safety (MFDS) and confirmed that the use of electronic systems such as Florence is compliant with requirements in South Korea.

Florence complies with numerous regulations within South Korea, such as the following which directly support the use of Florence ranging from topics of electronic document management, electronic signatures and remote monitoring.

  • Regulation on Management of Essential Documents of Clinical Trials on Medical Devices
  • Regulation on Approval for Investigational New Drug Application of Drugs
  • The Medical Device Act

Privacy Considerations

Florence’s Site Enablement Platform can be used in compliance with the Personal Information Protection Act in South Korea.

Additional Resources

Florence customers have access to additional resources to support their compliance efforts, reach out to your Florence contact for additional information!

  • User Acceptance Testing Validation Templates
  • Shared Responsibility Model
  • SOP templates

  • Full listing of regulations Florence complies with globally

Trusted by Sponsors & CROs, Loved by Sites