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Regulatory Services
1. Complete Service as a Designated MAH (DMAH) for Foreign Manufacturer
2. Documentation for Shonin Application (Marketing Authorization)
3. Expert Technical Translation
4. Clinical Trial Management
5. Preliminary Consultation for GCP Compatibility of Foreign Clinical Data with Japanese Requirements
6. Reimbursement Application for National Health Insurance
7. Post Marketing Surveillance
By Specialty
Orthopedics, Cardiovascular Surgery, Electro Physiology, General Surgery, Neurosurgery, Urology, Dermatology, Critical Care, Radiology and many more
By Product
Artificial Knee/Hip Joint, Cardiac Defibrillator, PTCA Balloon Catheter, EP Catheter & Analyzer, Surgical Ablation Unit, Surgical Laser, MRI/CT, And many more.