Regulatory Information

Regulations and Notifications

• Ministerial Ordinances
• Notifications and Administrative Notices

Regulatory Procedures

• Accreditation of Foreign Manufacturers
• Master File System
• GMP
• QMS

Guidance

The guidance below links to the website of the National Institute of Health Sciences.
 

• Guidance on Evaluation of Customized Orthopedic Devices for Osteosynthesis
• Guidance on Evaluation of Orthopedic Customized Artificial Hip Joint Prosthesis
• Guidance on Evaluation of the Devices for Physical Function Recovery
• Guidance on Evaluation of Accelerator Neutron Irradiation Device System for Boron Neutron Capture Therapy
• Guidance on Evaluation of Autologous Induced Pluripotent Stem Cells-derived Retinal Pigment Epithelial Cells
• Guidance on Evaluation of Orthopedic Custom-made Artificial Knee Joint Prosthesis
• Guidance for Evaluation of Three-dimensional Additive Manufacturing Technology-Based, Custom-made Orthopedic Implants Produced from Pateints' Image Data
• Guidance for Evaluation of Artificial Inteligence-Assisted Medical Imaging Systems For Clinical Diagnosis

Other Related Information

• New Regulations of Non-Corrective Colored Contact Lenses under the Pharmaceutical Affairs Law
• Issuance of Certificates for Medical Devices for Export
• Revision of Japanese Medical Device QMS requirements
• Procedures for Developing Post-marketing Study Plan
• Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2
• Checklist for GCP On-site Inspection/Document-based Compliance Assessment for New Drug (for Sponsor)
• Checklist for GCP On-site Inspection for New Drug (for Medical Institution)
• PMDA’s Support to Venture Companies
• PMDA’s Activities Leading to Medical Device Innovation

Frequently Asked Questions (FAQ)

1. Application for Product Approval
2. Acceptance of Medical Device Foreign Clinical Data
3. Accreditation of Foreign Manufacturers
4. Master File System