Latest Trends in the PMD Act Revision

Key Points for Medical Device Businesses to Understand

Table of Contents

• 1. Introduction
• 2. Overview of the Reiwa 7 (2025) PMD Act Revision
• 3. Background of the Revision
• 4. Main Points Particularly Relevant to Medical Device Businesses
  • 4-1. Strengthening Quality and Safety Assurance and Pharmaceutical Affairs Governance
  • 4-2. Product Database Registration and Barcode Utilization
  • 4-3. Clarification of Real-World Data Utilization
  • 4-4. Importance of a Stable Supply System
  • 4-5. Consultation System for Innovative Medical Device Development
• 5. What Medical Device Companies Should Prepare For in the Future
• 6. Conclusion

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1. Introduction

The Reiwa 7 (2025) revision of the Pharmaceutical and Medical Device Act (PMD Act), which was enacted and promulgated in 2025, appears to be primarily a system revision centered on pharmaceuticals, but it also holds significant implications for medical device businesses (References 1, 2).

The main pillars of this revision include ensuring the quality and safety of pharmaceuticals, stable supply of medical products, fostering an environment for drug discovery, and strengthening pharmacy functions. The Ministry of Health, Labour and Welfare (MHLW) is sequentially publishing ministerial ordinances, notifications, and circulars related to the revised law, with phased system development progressing, including provisions effective in November 2025 and May 2026.

In the medical device sector, issues such as product databases, barcode labeling, real-world data, post-market performance evaluation, pharmaceutical affairs governance, and stable supply will become even more critical.

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2. Overview of the Reiwa 7 (2025) PMD Act Revision

The Reiwa 7 (2025) PMD Act revision is formally titled “Act Partially Amending the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.” The MHLW explains this revision as a systemic review aimed at promptly and appropriately providing the public with pharmaceuticals and other products of assured quality.

The four main pillars of the revision are:

1. Strengthening the assurance of quality and safety of pharmaceuticals and other products.
2. Strengthening the stable supply system for medical pharmaceuticals and other products.
3. Establishing an environment for more active drug discovery.
4. Strengthening pharmacy functions for the appropriate provision of pharmaceuticals to the public.

The MHLW's summary document indicates the establishment of a quality assurance manager and safety management manager at marketing authorization holders, orders for changes in responsible executives in case of legal violations, establishment of a supply system management manager for medical pharmaceuticals, and reporting obligations during supply suspensions.

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3. Background of the Revision

The background to this revision includes recent drug shortages, quality misconduct incidents, changes in the drug discovery environment, and changes in the roles of pharmacies and pharmacists.

In particular, quality misconduct and supply shortages are critical issues common not only to the pharmaceutical industry but also to the medical device industry. Medical devices and instruments used in clinical settings are required not only to be effective and safe but also to be supplied stably, to have product information accurately managed, and to allow for prompt recall and information provision in the event of problems.

Therefore, this PMD Act revision shifts its focus from a