One Stop solution for your medical device to enter Japanese market

  • PMDA*, Notified Body Approval, Regulatory Document Preparation, correspondance for obtaining liense of your product on beharf of you foreign manufacturers.
  • QMS certificate, GVP operation
  • Reimbursement application
  • Save your cost serving you as Designated Marketing Approval Holder “DMAH”
  • Support to keep your license on your hand
  • Manufacturing business licenses registration
  • Reviewing of test reports (safety, efficiency)
  • Consultation

*PMDA
Abbreviation for Pharmaceuticals and Medical Devices Agency.
The PMDA plays the three roles of review, safety, and relief with regard to pharmaceuticals and medical devices, and conducts approval reviews, research work, and information provision for the sale of medical devices based on the Pharmaceutical Affairs Law.