June 24, 2025

Japan is one of the world’s largest and most regulated medical device markets. The Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW) oversee a rigorous approval process to ensure safety, quality, and efficacy. Here’s a concise guide to the latest regulatory requirements and how to successfully register your medical devices in Japan.

 

Key Regulatory Framework

1. Product Classification

  • Medical devices are classified into four categories (Class I–IV) based on risk:
    • Class I: General (low risk, e.g., tongue depressors)
    • Class II: Controlled (moderate risk, e.g., infusion sets)
    • Class III: Specially Controlled (higher risk, e.g., implantable devices)
    • Class IV: Highest Risk (e.g., pacemakers)
  • Classification determines the registration pathway and documentation required.

2. Marketing Authorization Holder (MAH) Requirement

  • Only a Japan-based MAH can submit applications and hold product approvals.
  • Foreign manufacturers must appoint a Designated Marketing Authorization Holder (DMAH) if they lack a local subsidiary.

3. Foreign Manufacturer Accreditation (FMA)

  • All overseas manufacturing sites must obtain FMA from MHLW before device registration.
  • FMA ensures compliance with Japanese GMP (QMS Ordinance).

4. Application Dossier (STED Format)

  • Prepare a Summary Technical Documentation (STED) dossier, aligning with global IMDRF/GHTF guidelines.
  • Dossier includes device description, intended use, risk analysis, clinical data, and QMS evidence.

5. e-Submission and Language

  • Electronic submissions are encouraged, especially for higher-risk devices.
  • Most documents can be in English, but key forms and summaries must be translated into Japanese.

6. Review Pathways

  • Class I: Notification to PMDA/MHLW (self-certification).
  • Class II: Third-party certification or PMDA review (if no certification standard exists).
  • Class III & IV: Full PMDA review, including clinical evaluation and QMS audit.

7. Post-Market Surveillance

  • MAH/DMAH must submit periodic safety reports, manage adverse event reporting, and comply with recalls or field safety corrective actions.
  • QMS audits are conducted regularly to ensure ongoing compliance.

 

Recent Regulatory Updates (2024–2025)

  • Digital Transformation: PMDA is expanding eCTD-like digital submissions for medical devices.
  • Faster Review for Innovative Devices: Accelerated pathways for breakthrough and orphan devices.
  • Labeling Requirements: Enhanced UDI (Unique Device Identification) and bilingual labeling (Japanese/English) for greater transparency.
  • Expanded Scope: Some software as a medical device (SaMD) and AI-based products now require full PMDA review.

 

How Maven Supports Medical Device Registration in Japan

1. Regulatory Strategy & Classification

  • Assess device risk class and optimal registration pathway.

2. Dossier Preparation & Translation

  • Compile STED dossier, translate required documents, and ensure QMS evidence meets Japanese standards.

3. FMA & MAH/DMAH Services

  • Secure FMA for manufacturing sites and act as your DMAH for seamless local representation.

4. Digital Submission Management

  • Navigate PMDA’s electronic submission systems and track application status.

5. Post-Market Compliance

  • Support with vigilance, safety reporting, and QMS audits.

 

Conclusion

Japan’s medical device regulatory landscape is complex but offers significant market potential for compliant manufacturers. Success depends on accurate classification, robust documentation, and strong local partnerships. Maven’s regulatory experts can guide you through every step—from FMA and dossier preparation to post-market surveillance—ensuring your medical devices reach Japanese patients safely and efficiently.