Table of Contents

Business Setup & Operations

• Startup Visa
• Setting up a Business in Japan
• How Foreign Startups Can Raise Funds in Japan
  Also in: Fund Raising
• Company Establishment
• Life Science & Startup Hubs
  Also in: Licensing & Partnering

Public Support

• Home-Country Public Support for Entering the Japanese Market
  Also in: Licensing & Partnering
• Using JETRO for Japan market entry
  Also in: Licensing & Partnering
• Public Support in Yokohama City

Regulatory & Compliance

• PMDA Consultation
  All PMD Act products
• Guide to Selecting Regulatory Affairs Staff & Consultants
  All PMD Act products
• Expedited Review Systems for Pharmaceuticals
  PharmaceuticalAlso in: Pharmaceutical, Regenerative Medical Product
• Guidelines for Establishing Generic Drug Names
  PharmaceuticalAlso in: Pharmaceutical, Regenerative Medical Product
• Combination Products, Combination Medical Device, Kit Products, Combination Drugs
  All PMD Act productsAlso in: Pharmaceutical, Regenerative Medical ProductMedical Device, IVD
• References in English

Pharmaceutical, Regenerative Medical Product

• How to Determine if a Product is a Pharmaceutical Drug
  PharmaceuticalAlso in: Regulatory & Compliance
• Advanced Medical Care System
  All PMD Act products
• Over-The-Counter (OTC) Drug
  PharmaceuticalAlso in: Regulatory & Compliance
• References on Reimbursement (Cost Calculation) for Regenerative Medical Products
  Regenerative medical productAlso in: Regulatory & Compliance

Medical Device, IVD

• IVD, LDT, RUO
  IVD
• DMAH: Designated Marketing Authorization Holder-Summary Ver.
  Medical deviceAlso in: Regulatory & Compliance
• How to Determine if a Product is a Medical Device
  Medical deviceHealthcare (non-medical)Also in: Regulatory & Compliance
• Medical Device Classification for Combined Products
  Medical deviceAlso in: Regulatory & Compliance
• Medical Device Classification (Class I–IV) in Japan: How to Determine a Device's Class
  Medical deviceAlso in: Regulatory & Compliance
• How to Confirm JMDN of a Medical Device
  Medical deviceAlso in: Regulatory & Compliance
• Medical Device & IVD Reimbursement-Summary Ver.
  Medical deviceIVDAlso in: Regulatory & Compliance
• Medical Device & IVD Reimbursement
  Medical deviceIVDAlso in: Regulatory & Compliance
• Comparison of Medical Device Definitions: Japan, US, & EU
  Medical deviceAlso in: Regulatory & Compliance
• Companion Diagnostics and Gene Panel Testing
  PharmaceuticalIVDAlso in: Regulatory & Compliance

Healthcare Products, Caretech

• Guidance for Non-Medical Services
  Healthcare (non-medical)
• Therapeutic Orthoses and Assistive Devices
  Healthcare (non-medical)Also in: Regulatory & ComplianceMedical Device, IVD
• Cosmetics and Quasi-drugs
  Cosmetics & quasi-drugsAlso in: Regulatory & CompliancePharmaceutical, Regenerative Medical Product
• Overseas Expansion of Non-Medical Devices as Medical Devices
  Medical deviceHealthcare (non-medical)Also in: Medical Device, IVD
• Medical Device vs Non-Medical Device-Product Positioning Strategy
  Medical deviceHealthcare (non-medical)Also in: Regulatory & ComplianceMedical Device, IVD

Fund Raising

• Public Grants and Subsidies
• J-SHIPS

Intellectual Property

• Patent or Trade Secret?
• Employee Invention
  Also in: Academia & Tech Transfer
• Matching of Patents Held by Startups and Individuals

Legal & Contracts

• References for Contracts
• Guide to Industry-Academia Collaboration Agreements
  Also in: Intellectual PropertyAcademia & Tech Transfer

Licensing & Partnering

• Networking, Partnering
• Introducing Seeds to Pharmaceutical Companies
  Also in: Pharmaceutical, Regenerative Medical ProductMedical Device, IVD
• Incentives (Returns) to Licensor Universities
  Also in: Intellectual PropertyAcademia & Tech Transfer