Presentation: Global Regulatory Partners GK: Current Capabilities in Japan

Reviewed Topics:

  • GRP Services in Japan
  • Medical Device Classification
  • Registration Flow of Medical Devices
  • Content of Registratoin Dossier (STED)
  • Manufacturing Site Accreditation (FMA)
  • GRP Quality Services
  • QMS inspection
  • QMS application
  • Reimbursement of Medical Device
  • ICC services

https://globalregulatorypartners.com/countries/asia/japans-pmda/