Applicability to Your Company
Confirm whether the amended provisions relate to your licenses or registrations, marketing authorization activities, products, or business model.
2025 PMD Act Amendment: What Medical Device Companies Should Review
The 2025 amendment to the Pharmaceuticals and Medical Devices Act (PMD Act) and related legislation was promulgated on May 21, 2025, and its provisions are being brought into force in stages.
Because the amendment also includes provisions primarily concerning pharmaceuticals, medical device companies should not decide their response simply on the basis that "the Act was amended." They need to identify the provisions relevant to their business licenses and registrations, products, business model, and post-market responsibilities.
First Confirm Which Provisions Apply to Your Company and When They Take Effect
When responding to a legislative amendment, first review the latest laws, ordinances, ministerial regulations, notifications, and related materials and identify the provisions and effective dates relevant to your company.
Not all provisions of an amending act necessarily take effect at the same time.
In addition, related ministerial ordinances, notifications, and other materials may be issued after promulgation. It is therefore important not to finalize implementation based only on older summary materials.
In addition to the 2025 PMD Act amendment itself, this article highlights existing medical device regulatory practices that are useful to review when implementing the amendment.
Basic Items to Confirm When Responding to the Amendment
Effective Date
Confirm when the provisions relevant to your company take effect.
Related Ordinances and Notifications
Review not only the text of the Act but also the latest ministerial ordinances, notifications, administrative communications, and other materials that affect practical implementation.
Internal Rules and Procedures
Determine whether the amendment requires changes to internal policies, procedures, allocation of responsibilities, records, or forms.
Division of Responsibilities with Overseas Manufacturers
Confirm whether there are any changes to the information that overseas manufacturers must provide to the Japanese side or to communication methods for design changes, manufacturing changes, defects, or safety information.
Medical Device Regulatory Practices to Review When Implementing the Amendment
The following items are not all new obligations created by the 2025 amendment.
Rather, the amendment provides a useful opportunity to confirm whether existing regulatory practices are operating appropriately.
Quality Management
Confirm that quality management based on the QMS, including change control and nonconforming product control, is functioning in actual operations.
Post-Market Safety Management
Confirm that domestic and overseas defects, complaints, and safety information are appropriately collected and evaluated and can be linked to the actions required in Japan.
Change Control
Confirm that the Japanese organization receives information concerning changes to design, raw materials, manufacturing processes, manufacturing sites, sterilization, labeling, and other matters in time to determine whether a regulatory procedure is required.
Product Information
Confirm that trade names, generic names, lot information, expiration dates, labeling, package inserts, and related product information can be managed accurately.
Supply System
Review manufacturing sites, key materials, sterilization, logistics, and other factors for risks that could lead to supply interruptions and confirm available alternatives.
How to Reflect the Amendment in Practice
- 01
Review the Latest Official Materials
Confirm the latest amendment text, effective dates, ministerial ordinances, notifications, and related official materials.
- 02
Identify the Provisions That Apply to Your Company
Identify the provisions relevant to your business category, licenses and registrations, products, and role.
- 03
Compare the Requirements with Current Internal Operations
Compare the amended requirements with current internal rules, procedures, contracts, records, and forms.
- 04
Implement Necessary Changes
Update internal rules, procedures, allocation of responsibilities, and communication methods with related companies as necessary.
- 05
Confirm Operation After the Effective Date
Confirm that revised systems are operating in practice and that the required records are being maintained.
Also Review Information Sharing with Overseas Manufacturers
When products from an overseas manufacturer are marketed in Japan, it is important that the Japanese side can obtain change information and defect information in a timely manner.
In particular, establish information-sharing procedures for matters such as:
- Design changes
- Raw material changes
- Manufacturing site changes
- Manufacturing process changes
- Sterilization condition changes
- Overseas defects and recalls
- Labeling and IFU changes
so that the Japanese side can evaluate their regulatory impact.
Frequently Asked Questions
Does Every Provision of the 2025 Amendment Apply to Medical Device Companies?
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No. Some provisions mainly concern pharmaceuticals. Each company should identify the provisions that apply to its business and products.
Is It Enough to Review the Summary Published at the Time of Promulgation?
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Not necessarily. Effective dates and practical implementation may depend on ministerial ordinances, notifications, and other materials issued after promulgation.
Should Existing Internal Rules Also Be Reviewed?
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Yes. If relevant provisions apply to your company, review the impact on internal policies, procedures, responsibilities, records, and forms.
Related guides: Medical Device Regulatory Requirements in Japan | Post-Market Safety Management for Medical Devices in Japan
Official Sources
For the latest official information on Japan's 2025 PMD Act amendment, related ordinances and implementation notices, refer to the following MHLW source.
Contact Us About Responding to PMD Act Amendments
We review your business category and products and organize the items that should be confirmed based on the latest official materials.
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